Parkinson Disease
Conditions
Keywords
Telemedicine, Virtual care visit, Remote visit, Video-conferencing
Brief summary
The primary objective of this study is to evaluate the feasibility, efficacy and the value of providing care to individuals with Parkinson disease directly into their homes. The specific aims are: 1. To demonstrate the feasibility of conducting remote evaluations of patients with Parkinson disease nationally; 2. To measure the impact of remote care on each patient's ability to improve his or her quality of life (QoL) and better manage his or her Parkinson disease; and 3. To assess the long-term acceptability to patients in receiving ongoing care remotely via telemedicine.
Interventions
OTHERVirtual care visit
Video-conferencing visit with a Parkinson disease specialist
Sponsors
Davis Phinney Foundation
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than 30 * Self reported diagnosis of idiopathic Parkinson disease * Ability to converse in English * Ability and willingness to provide informed consent and complete study requirements * Access to a non-public computer or similar devices with broadband internet. * Located in New York, Maryland, Delaware, California, or Florida at time of virtual visit (or veterans with Parkinson disease anywhere in the U.S.)
Exclusion criteria
* Any condition (e.g.prominent psychosis) that in the investigator's or coordinator's judgment would preclude participation. * Concurrent enrollment in another telemedicine study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 6 months | The percent of telemedicine visits completed as scheduled. (Goal \>80%) |
| Change in Quality of Life as Measured by the PDQ-39 Assessment Tool | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 6 months | \- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal \>80%) |
| Feasibility (Descriptive) | 6 months | Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall. |
| Percentage of Patients Who Felt That the Recommendations Improved Their Health | 6 months | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Care Visit One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist | 277 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | technology incompatibility | 9 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Virtual Care Visit |
|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 9.1 |
| Gender Female | 138 Participants |
| Gender Male | 139 Participants |
| Region of Enrollment United States | 277 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 277 |
| serious Total, serious adverse events | 0 / 277 |
Outcome results
Primary
Change in Quality of Life as Measured by the PDQ-39 Assessment Tool
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Care Visit | Change in Quality of Life as Measured by the PDQ-39 Assessment Tool | 0.4 units on a scale |
p-value: 0.39t-test, 2 sided
Primary
Feasibility
The percent of telemedicine visits completed as scheduled. (Goal \>80%)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Care Visit | Feasibility | 91 percentage of visits |
Secondary
Acceptability
\- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal \>80%)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Care Visit | Acceptability | 74 percentage of participants |
Secondary
Feasibility (Descriptive)
Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Care Visit | Feasibility (Descriptive) | 94 percentage of visits |
Secondary
Percentage of Patients Who Felt That the Recommendations Improved Their Health
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Care Visit | Percentage of Patients Who Felt That the Recommendations Improved Their Health | 56 percentage of participants |