Trial Outcomes & Findings for Remote Access to Care, Everywhere, for Parkinson Disease (NCT NCT02144220)

NCT ID: NCT02144220

Last Updated: 2017-02-23

Results Overview

The percent of telemedicine visits completed as scheduled. (Goal \>80%)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 277 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-02-23

Participant Flow

Recruitment was primarily online through mass email messaging from the Davis Phinney Foundation, internet listings on Fox Trial Finder, messages from PatientsLikeMe, Google AdWords in eligible states, and outreach to support groups.

Individuals indicated their interest in participating by either visiting the Davis Phinney Foundation's "funded research" web page where individuals completed an online screening survey or by contacting study coordinators by phone or email.

Participant milestones

Measure	Virtual Care Visit One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Overall Study STARTED	277
Overall Study COMPLETED	258
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Virtual Care Visit One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Overall Study technology incompatibility	9
Overall Study Lack of Efficacy	4
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	1

Baseline Characteristics

Remote Access to Care, Everywhere, for Parkinson Disease

Baseline characteristics by cohort

Measure	Virtual Care Visit n=277 Participants One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Age, Continuous	67.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Gender Female	138 Participants n=5 Participants
Gender Male	139 Participants n=5 Participants
Region of Enrollment United States	277 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The percent of telemedicine visits completed as scheduled. (Goal >80%)

Outcome measures

Measure	Virtual Care Visit n=277 Participants One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Feasibility	91 percentage of visits

PRIMARY outcome

Timeframe: Baseline and 6 months

The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.

Outcome measures

Measure	Virtual Care Visit n=258 Participants One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Change in Quality of Life as Measured by the PDQ-39 Assessment Tool	0.4 units on a scale Interval -1.5 to 0.6

SECONDARY outcome

Timeframe: 6 months

• The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%)

Outcome measures

Measure	Virtual Care Visit n=258 Participants One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Acceptability	74 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.

Outcome measures

Measure	Virtual Care Visit n=258 Participants One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Feasibility (Descriptive)	94 percentage of visits

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Virtual Care Visit n=258 Participants One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Percentage of Patients Who Felt That the Recommendations Improved Their Health	56 percentage of participants

Adverse Events

Virtual Care Visit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ray Dorsey, MD

University of Rochester

Phone: 585-275-0663

Email: ray.dorsey@chet.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place