Idiopathic Parkinson's Disease
Conditions
Keywords
Rotigotine, Neupro®, Parkinson, Treatment preference, Care-giving
Brief summary
The study objective is to evaluate advantages and disadvantages of Neupro® versus oral anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease patients requiring caregiver support in nursing home or outpatient care settings.
Interventions
DRUGNeupro®
Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed.
Sponsors
UCB Pharma
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Only patients having signed the consent form regarding study information, data transfer and data use * The patients suffer from idiopathic Parkinson's Disease (iPD) treated with a combination of L-dopa or another oral iPD drug and Neupro® for at least one month * The patients require caregiver support documented as per medical records (e.g. based on German level of care intensity 1 or greater) * The decision to prescribe Neupro® must have been made by the physician independent of his/her decision to include the patient in the study
Exclusion criteria
* Patients not fulfilling the inclusion criteria * And according to Summary of Product Characteristics (SmPC): Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting. | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers. |
| Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians. |
| Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month. | The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable. |
Countries
Germany
Participant flow
Recruitment details
Patients participating in this study were in need of care either by family members at home or by professional nurses in outpatient care or nursing homes. The Participant Flow refers to the Enrolled Set (ES). All patients who were entered into the database are included in the Enrolled Set (ES).
Pre-assignment details
The physicians were instructed to select idiopathic Parkinson's Disease (iPD) patients with documented need of care with caregivers/nurses who attended patients at home as caregiving family members or as professional nurses in outpatient care or nursing homes.
Participants by arm
| Arm | Count |
|---|---|
| Neupro® Treatment Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed. | 148 |
| Total | 148 |
Baseline characteristics
| Characteristic | Neupro® Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 131 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age Continuous | 74.61 years STANDARD_DEVIATION 8.26 |
| Height | 168.39 centimeters STANDARD_DEVIATION 10.28 |
| Region of Enrollment Germany | 148 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 88 Participants |
| Type of care-giving: Patient lives at nursing home Missing | 24 participants |
| Type of care-giving: Patient lives at nursing home No | 108 participants |
| Type of care-giving: Patient lives at nursing home Yes | 16 participants |
| Weight | 73.43 kilogram STANDARD_DEVIATION 14.71 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 148 |
| serious Total, serious adverse events | 0 / 148 |
Outcome results
Primary
Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication | 1.32 units on a scale | Standard Deviation 0.67 |
Primary
Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication | 1.46 units on a scale | Standard Deviation 0.32 |
Secondary
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neupro® Treatment | Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Applicable | 139 participants |
| Neupro® Treatment | Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Not applicable | 7 participants |
| Neupro® Treatment | Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Missing | 1 participants |
Secondary
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neupro® Treatment | Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Applicable | 89 participants |
| Neupro® Treatment | Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Not applicable | 57 participants |
| Neupro® Treatment | Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support | Missing | 1 participants |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts | 1.03 units on a scale | Standard Deviation 0.98 |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance | 1.33 units on a scale | Standard Deviation 0.93 |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia | 1.44 units on a scale | Standard Deviation 0.94 |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication | 1.49 units on a scale | Standard Deviation 0.79 |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting | 1.50 units on a scale | Standard Deviation 0.91 |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration | 1.54 units on a scale | Standard Deviation 0.77 |
Secondary
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients | 1.19 units on a scale | Standard Deviation 0.91 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance | 1.36 units on a scale | Standard Deviation 0.59 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption | 1.35 units on a scale | Standard Deviation 0.75 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia | 1.59 units on a scale | Standard Deviation 0.82 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication | 1.48 units on a scale | Standard Deviation 0.6 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting. | 1.48 units on a scale | Standard Deviation 0.54 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption | 1.64 units on a scale | Standard Deviation 0.55 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments | 1.15 units on a scale | Standard Deviation 0.63 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia | 1.87 units on a scale | Standard Deviation 0.32 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration | 1.50 units on a scale | Standard Deviation 0.44 |
Secondary
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro® Treatment | Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients | 1.37 units on a scale | Standard Deviation 0.58 |