Parkinson's Disease
Conditions
Keywords
LCIG, Parkinson's disease, levodopa carbidopa intestinal gel, Telemedicine
Brief summary
The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.
Detailed description
Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.
Interventions
None listed
Sponsors
AbbVie
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics 2. Motivated and confident to test Duodopa home titration using TM 3. Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator 4. Understood and signed the study informed consent form
Exclusion criteria
1. Dementia or cognitive decline with Mini Mental State Examination score less than 24 2. Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator 3. Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery 4. Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time. |
| Median Number of Contacts | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Technical Events | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population. |
| Incidence of Technical Events Experienced by Participants | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34). |
| Percentage of Participants With Consequences | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population. |
| Incidence of Consequences Due to Technical Events | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43). |
| Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population. |
| Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34). |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information. |
| Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Median Total Time for Titration | From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range. |
| Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other). |
| Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization). |
| Median Time Spent for Health Care Utilization Outside the TM Care Chain | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range. |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information. |
| Median Total Free Time of Participant | From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days | Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Parkinson's Disease Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Participants With Parkinson's Disease |
|---|---|
| Age, Continuous | 65.5 Years STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Median Number of Contacts
Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator + DNS: TM | 5.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator: Home Visit | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Total Contact With Participant: All Types | 19.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Total Contact With Participant: TM | 13.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Total Contact With Participant: Telephone | 1.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Total Contact With Participant: Home Visit | 5.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Total Contact With Participant: Other | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator: All Types | 3.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator: TM | 2.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator: Telephone | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator: Other | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + DNS: All Types | 9.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + DNS: TM | 5.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + DNS: Telephone | 1.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + DNS: Home Visit | 3.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + DNS: Other | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator + DNS: All Types | 5.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator + DNS: Telephone | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator + DNS: Home Visit | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + Investigator + DNS: Other | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + TM Technician: All Types | 2.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + TM Technician: TM | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + TM Technician: Telephone | 0.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + TM Technician: Home Visit | 2.0 Number of contacts |
| Participants With Parkinson's Disease | Median Number of Contacts | Participant + TM Technician: Other | 0.0 Number of contacts |
Primary
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator: All Types (N=12) | 29.1 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator: TM (N=12) | 22.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator: Telephone (N=1) | 30.0 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator: Home Visit (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator: Other (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + DNS: All Types | 317.4 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + DNS: TM | 22.8 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + DNS: Telephone (N=8) | 15.9 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + DNS: Home Visit | 280.8 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + DNS: Other (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator + DNS: All Types | 45.0 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator + DNS: TM | 42.0 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator + DNS: Telephone (N=1) | 7.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator + DNS: Home Visit (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + Investigator + DNS: Other (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + TM Technician: All Types | 100.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + TM Technician: TM (N=1) | 1.8 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + TM Technician: Telephone (N=1) | 4.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + TM Technician: Home Visit | 100.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Participant + TM Technician: Other (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total DNS: All Types | 349.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total DNS: TM | 78.6 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total DNS: Telephone (N=8) | 15.9 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total DNS: Home Visit | 280.8 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total DNS: Other (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Investigator: All Types | 73.8 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Investigator: TM | 57.0 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Investigator: Telephone (N=1) | 37.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Investigator: Home Visit (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Investigator: Other (N=0) | NA Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Participant: All Types | 532.8 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total participant: TM | 100.2 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Participant: Telephone (N=8) | 15.9 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Participant: Home Visit | 345.0 Minutes |
| Participants With Parkinson's Disease | Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant | Total Participant: Other (N=0) | NA Minutes |
Secondary
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 4 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 5 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 6 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication? | Scale 7 (Very Satisfied) | 60.0 Percentage of participants |
Secondary
Incidence of Consequences Due to Technical Events
Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Any Consequence (N=11) | 100.0 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Contact Delay: Type A (N=1) | 2.3 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Contact Delay: Type B (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Contact Delay: Type C (N=3) | 7.0 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Contact Delay: Type D (N=3) | 11.6 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Re-establishment of Connection: Type A (N=1) | 2.3 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Re-establishment of Connection: Type B (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Re-establishment of Connection: Type C (N=4) | 9.3 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Re-establishment of Connection: Type D (N=5) | 18.6 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | TM-call Replaced by Telephone Call: Type A (N=3) | 7.0 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | TM-call Replaced by Telephone Call: Type B (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | TM-call Replaced by Telephone Call: Type C (N=4) | 11.6 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | TM-call Replaced by Telephone Call: Type D (N=7) | 23.3 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Failed Scheduled Contact: Type A (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Failed Scheduled Contact: Type B (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Failed Scheduled Contact: Type C (N=2) | 4.7 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Failed Scheduled Contact: Type D (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Other Consequence: Type A (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Other Consequence: Type B (N=0) | NA Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Other Consequence: Type C (N=2) | 7.0 Percentage of consequences |
| Participants With Parkinson's Disease | Incidence of Consequences Due to Technical Events | Other Consequence: Type D (N=0) | NA Percentage of consequences |
Secondary
Incidence of Technical Events Experienced by Participants
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Any Technical Event (N=11) | 100.0 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type A: Failure to Answer Video Call (AVC) (N=2) | 5.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type A: Other (N=1) | 2.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type B: Intentional Failure to AVC (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type B: Other (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type C: Mechanical (N=2) | 8.8 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type C: Electrical (N=3) | 14.7 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type C: Other (N=5) | 14.7 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type D: Failure to Establish Connection (N=6) | 32.4 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type D: Interruptions (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type D: Transmission Quality (N=2) | 5.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type D: Sound Quality (N=5) | 17.6 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type D: Image Quality (N=1) | 2.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants | Type D: Other (N=1) | 2.9 Percentage of technical events |
Secondary
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Any Technical Event (N=11) | 100.0 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type A: Contact Delay (N=1) | 2.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type A: Re-establishment of Connection (N=1) | 2.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type A: TM-call Replaced by Telephone Call (N=3) | 8.8 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type A: Failed Scheduled Contact Failure (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type A: Other Consequence (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type B: Contact Delay (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type B: Re-establishment of Connection (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type B: TM-call Replaced by Telephone Call (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type B: Failed Scheduled Contact Failure (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type B: Other Consequence (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type C: Contact Delay (N=3) | 8.8 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type C: Re-establishment of Connection (N=4) | 11.8 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type C: TM-call Replaced by Telephone Call (N=4) | 14.7 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type C: Failed Scheduled Contact Failure (N=2) | 5.9 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type C: Other Consequence (N=2) | 8.8 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type D: Contact Delay (N=3) | 14.7 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type D: Re-establishment of Connection (N=5) | 23.5 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type D: TM-call Replaced by Telephone Call (N=7) | 29.4 Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type D: Failed Scheduled Contact Failure (N=0) | NA Percentage of technical events |
| Participants With Parkinson's Disease | Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence | Type D: Other Consequence (N=0) | NA Percentage of technical events |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | Investigator Experience: More | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | Investigator Experience: Equal | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | Investigator Experience: Less | 60.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | DNS Experience: More | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | DNS Experience: Equal | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact? | DNS Experience: Less | 93.3 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | Investigator Experience: More | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | Investigator Experience: Equal | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | Investigator Experience: Less | 66.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | DNS Experience: More | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | DNS Experience: Equal | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact? | DNS Experience: Less | 60.0 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | Investigator Experience: More | 53.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | Investigator Experience: Equal | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | Investigator Experience: Less | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | DNS Experience: More | 93.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | DNS Experience: Equal | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts? | DNS Experience: Less | 0.0 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 4 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 5 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 6 | 53.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | Investigator Experience: Scale 7-Very Satisfied | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 5 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 6 | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs? | DNS Experience: Scale 7-Very Satisfied | 40.0 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 6 | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 5 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 6 | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | Investigator Experience: Scale 7--Very Satisfied | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 4 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 5 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? | DNS Experience: Scale 7--Very Satisfied | 46.7 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 3 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 5 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 6 | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | Investigator Experience: Scale 7-Very Satisfied | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 4 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 5 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 6 | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments? | DNS Experience: Scale 7-Very Satisfied | 40.0 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 3 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 5 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 6 | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | Investigator Experience: Scale 7-Very Satisfied | 66.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 5 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 6 | 33.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant? | DNS Experience: Scale 7-Very Satisfied | 46.7 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 3 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 4 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 5 | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 6 | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | Investigator Experience: Scale 7-Very Satisfied | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 4 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 5 | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 6 | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant? | DNS Experience: Scale 7-Very Satisfied | 20.0 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 5 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 6 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | Investigator Experience: Scale 7-Very Satisfied | 73.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 5 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 6 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment? | DNS Experience: Scale 7-Very Satisfied | 80.0 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 5 | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 5 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 6 | 60.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | Investigator Experience: Scale 7-Very Satisfied | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 2 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 6 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment? | DNS Experience: Scale 7-Very Satisfied | 46.7 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 5 | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 6 | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | Investigator Experience: Scale 7-Very Satisfied | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 3 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 5 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 6 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? | DNS Experience: Scale 7-Very Satisfied | 66.7 Percentage of participants |
Secondary
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 5 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 6 | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | Investigator Experience: Scale 7-Very Satisfied | 66.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 1-Very Dissatisfied | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 4 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 5 | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 6 | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM? | DNS Experience: Scale 7-Very Satisfied | 66.7 Percentage of participants |
Secondary
Median Time Spent for Health Care Utilization Outside the TM Care Chain
The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Parkinson's Disease | Median Time Spent for Health Care Utilization Outside the TM Care Chain | 190.8 Minutes |
Secondary
Median Total Free Time of Participant
Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.
Time frame: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Parkinson's Disease | Median Total Free Time of Participant | 3865.2 Minutes |
Secondary
Median Total Time for Titration
The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.
Time frame: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Parkinson's Disease | Median Total Time for Titration | 4093.2 Minutes |
Secondary
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact
The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact | Telephone | 0 Number of participants |
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact | Other | 0 Number of participants |
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact | Home or Outpatient Visit | 1 Number of participants |
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact | Hospitalization | 0 Number of participants |
Secondary
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider | General Practitioner | 0 Number of participants |
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider | Emergency Ward | 0 Number of participants |
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider | Other Neurologist | 0 Number of participants |
| Participants With Parkinson's Disease | Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider | Other | 1 Number of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 1 (Very Unconfident) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 5 | 14.3 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 6 | 42.9 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments? | Scale 7 (Very Confident) | 42.9 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 1 (Very Unsecure) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 4 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 5 | 14.3 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 6 | 14.3 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa? | Scale 7 (Very Secure) | 64.3 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 7 (Very Satisfied) | 88.9 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 5 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home? | Scale 6 | 11.1 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 5 | 16.7 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 1 (Very Unconfident) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 6 | 16.7 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump? | Scale 7 (Very Confident) | 66.7 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 4 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 5 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 6 | 28.6 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? | Scale 7 (Very Satisfied) | 57.1 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 1 (Very Hard) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 4 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 5 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 6 | 35.7 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? | Scale 7 (Very Easy) | 50.0 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 5 | 14.3 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 6 | 28.6 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? | Scale 7 (Very Satisfied) | 57.1 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 5 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 6 | 35.7 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? | Scale 7 (Very Satisfied) | 57.1 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 5 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 6 | 21.4 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)? | Scale 7 (Very Satisfied) | 71.4 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 3 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 5 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 6 | 28.6 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home? | Scale 7 (Very Satisfied) | 64.3 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 3 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 5 | 14.3 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 6 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home? | Scale 7 (Very Satisfied) | 78.6 Percentage of participants |
Secondary
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 1 (Very Dissatisfied) | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 2 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 3 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 4 | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 5 | 7.1 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 6 | 21.4 Percentage of participants |
| Participants With Parkinson's Disease | Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment? | Scale 7 (Very Satisfied) | 64.3 Percentage of participants |
Secondary
Percentage of Participants Who Experienced Technical Events
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type A: Failure to Answer Video Call | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type A: Other | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type B: Intentional Failure to Answer Video Call | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type B: Other | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type C: Mechanical | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type C: Electrical | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type C: Other | 33.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type D: Failure to Establish Connection | 40.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type D: Interruptions | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type D: Transmission Quality | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type D: Sound Quality | 33.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type D: Image Quality | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Type D: Other | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events | Any Technical Event | 73.3 Percentage of participants |
Secondary
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Any Technical Event | 73.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type A: Contact Delay | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type A: Re-establishment of Connection | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type A: TM-call Replaced by Telephone Call | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type A: Failed Scheduled Contact Failure | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type A: Other Consequence | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type B: Contact Delay | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type B: Re-establishment of Connection | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type B: TM-call Replaced by Telephone Call | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type B: Failed Scheduled Contact Failure | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type B: Other Consequence | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type C: Contact Delay | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type C: Re-establishment of Connection | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type C: TM-call Replaced by Telephone Call | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type C: Failed Scheduled Contact Failure | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type C: Other Consequence | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type D: Contact Delay | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type D: Re-establishment of Connection | 33.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type D: TM-call Replaced by Telephone Call | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type D: Failed Scheduled Contact Failure | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence | Type D: Other Consequence | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | Very Much Improved | 28.6 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | Much Improved | 71.4 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | Minimally Improved | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | No Change | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | Minimally Worse | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | Much Worse | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms | Very Much Worse | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Consequences
Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Failed Scheduled Contact: Type A | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Failed Scheduled Contact: Type B | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Any Consequence | 73.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Contact Delay: Type A | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Contact Delay: Type B | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Contact Delay: Type C | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Contact Delay: Type D | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Re-establishment of Connection: Type A | 6.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Re-establishment of Connection: Type B | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Re-establishment of Connection: Type C | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Re-establishment of Connection: Type D | 33.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | TM-call Replaced by Telephone Call: Type A | 20.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | TM-call Replaced by Telephone Call: Type B | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | TM-call Replaced by Telephone Call: Type C | 26.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | TM-call Replaced by Telephone Call: Type D | 46.7 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Failed Scheduled Contact: Type C | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Failed Scheduled Contact: Type D | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Other Consequence: Type A | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Other Consequence: Type B | 0.0 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Other Consequence: Type C | 13.3 Percentage of participants |
| Participants With Parkinson's Disease | Percentage of Participants With Consequences | Other Consequence: Type D | 0.0 Percentage of participants |
Secondary
Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Parkinson's Disease | Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital? | Investigator Experience | 73.3 Percentage of participants |
| Participants With Parkinson's Disease | Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital? | DNS Experience | 60.0 Percentage of participants |
Secondary
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Parkinson's Disease | Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment? | 92.9 Percentage of participants |
Secondary
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Parkinson's Disease | Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period? | 88.9 Percentage of participants |
Secondary
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?
From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Parkinson's Disease | Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment? | 100.0 Percentage of participants |
Secondary
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Population: The analysis was performed using FAS with non-missing information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Parkinson's Disease | Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration? | 92.9 Percentage of participants |