Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes

Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02038959

Enrollment

210

Registered

2014-01-17

Start date

2014-03-31

Completion date

2016-08-31

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson disease, Parkinson's, Parkinson's disease, telemedicine, virtual visits, video calls, video conferencing, virtual house calls

Brief summary

Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following: 1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care; 2. To show that such an approach can improve quality of life; 3. To establish that the telemedicine can enhance the quality of care; and 4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.

Detailed description

Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's usual care supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.

Interventions

OTHERVirtual Visits

Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater * No better alternative explanation for the parkinsonism * Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing * Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine * Have a local care provider that the study team can contact * Live at home, in a senior housing complex, or assisted living facility * Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only) * Willing and able to provide informed consent * Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.

Exclusion criteria

* Currently hospitalized * Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse). * Participation in another telemedicine study.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of Virtual Visits for Parkinson Disease	One year	Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.
Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39	Baseline to One year	Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.

Secondary

Measure	Time frame	Description
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA	baseline to one year	Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.
Change in Patient Assessment of Chronic Illness Care	baseline to one year	We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.
Minutes Spend on Last Parkinson's Disease Provider Visit	One year	—
Change in EQ-5D Index Value	baseline to one year	EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2	baseline to one year	Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3	baseline to one year	Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4	baseline to one year	Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB	baseline to one year	Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.
Change in Montreal Cognition Assessment	baseline to one year	We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.

Countries

United States

Participant flow

Recruitment details

Individuals with Parkinson disease were recruited and enrolled remotely and sent educational materials about Parkinson disease created by the National Parkinson Foundation. Recruitment for the study began in February 2014.

Pre-assignment details

272 individuals were referred to 18 sites to be consented. Two hundred ten individuals with Parkinson disease enrolled in the study, and 195 were eventually randomized.

Participants by arm

Arm	Count
Usual Care and Educational Materials Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.	98
Virtual Visits and Educational Materials Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone).	97
Total	195

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	6	8

Baseline characteristics

Characteristic	Virtual Visits and Educational Materials	Usual Care and Educational Materials	Total
Age, Continuous	65.9 years STANDARD_DEVIATION 7.8	66.9 years STANDARD_DEVIATION 8.5	66.4 years STANDARD_DEVIATION 8.1
Gender Female	49 Participants	42 Participants	91 Participants
Gender Male	48 Participants	56 Participants	104 Participants
Minutes spent with Parkinson disease provider	30 minutes	30 minutes	30 minutes
Region of Enrollment United States	97 Participants	98 Participants	195 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 98	0 / 97
serious Total, serious adverse events	0 / 98	0 / 97

Outcome results

Primary

Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39

Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.

Time frame: Baseline to One year

Population: Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.

Arm	Measure	Value (MEAN)	Dispersion
Usual Care and Educational Materials	Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39	-0.7512 units on a scale	Standard Error 0.9472
Virtual Visits and Educational Materials	Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39	-0.4123 units on a scale	Standard Error 1.0029

p-value: >0.05ANCOVA

Primary

Feasibility of Virtual Visits for Parkinson Disease

Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.

Time frame: One year

Arm	Measure	Value (NUMBER)
Usual Care and Educational Materials	Feasibility of Virtual Visits for Parkinson Disease	0 participants
Virtual Visits and Educational Materials	Feasibility of Virtual Visits for Parkinson Disease	95 participants

Secondary

Change in EQ-5D Index Value

EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).