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| Name | Class |
|---|---|
| Davis Phinney Foundation | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual care visit | Experimental | One-time virtual care visit for Parkinson disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual care visit | Other | Video-conferencing visit with a Parkinson disease specialist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | The percent of telemedicine visits completed as scheduled. (Goal >80%) | 6 months |
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | - The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%) | 6 months |
| Feasibility (Descriptive) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Ray Dorsey, MD, MBA | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco/San Francisco VA Medical Center | San Francisco | California | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23479138 | Background | Dorsey ER, Venkataraman V, Grana MJ, Bull MT, George BP, Boyd CM, Beck CA, Rajan B, Seidmann A, Biglan KM. Randomized controlled clinical trial of "virtual house calls" for Parkinson disease. JAMA Neurol. 2013 May;70(5):565-70. doi: 10.1001/jamaneurol.2013.123. | |
| 24790799 | Background | Venkataraman V, Donohue SJ, Biglan KM, Wicks P, Dorsey ER. Virtual visits for Parkinson disease: A case series. Neurol Clin Pract. 2014 Apr;4(2):146-152. doi: 10.1212/01.CPJ.0000437937.63347.5a. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Care Visit | One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Care Visit | One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility | The percent of telemedicine visits completed as scheduled. (Goal >80%) | Posted | Number | percentage of visits | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Care Visit | One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ray Dorsey, MD | University of Rochester | 585-275-0663 | ray.dorsey@chet.rochester.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.
| 6 months |
| Percentage of Patients Who Felt That the Recommendations Improved Their Health | 6 months |
| University of Florida |
| Gainesville |
| Florida |
| 32607 |
| United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| 17082464 | Background | Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007 Jan 30;68(5):384-6. doi: 10.1212/01.wnl.0000247740.47667.03. Epub 2006 Nov 2. |
| 23616157 | Background | Dorsey ER, George BP, Leff B, Willis AW. The coming crisis: obtaining care for the growing burden of neurodegenerative conditions. Neurology. 2013 May 21;80(21):1989-96. doi: 10.1212/WNL.0b013e318293e2ce. Epub 2013 Apr 24. |
| 21832214 | Background | Willis AW, Schootman M, Evanoff BA, Perlmutter JS, Racette BA. Neurologist care in Parkinson disease: a utilization, outcomes, and survival study. Neurology. 2011 Aug 30;77(9):851-7. doi: 10.1212/WNL.0b013e31822c9123. Epub 2011 Aug 10. |
| 23054239 | Background | Willis AW, Schootman M, Tran R, Kung N, Evanoff BA, Perlmutter JS, Racette BA. Neurologist-associated reduction in PD-related hospitalizations and health care expenditures. Neurology. 2012 Oct 23;79(17):1774-80. doi: 10.1212/WNL.0b013e3182703f92. Epub 2012 Oct 10. |
| Background | The European Parkinson's Disease Association. The european parkinson's disease standards of care consensus statement. http://www.kompetenznetzparkinson.de/EPDA_Parkinson_s_Standard_nsus_Statement_Vol_I.pdf>2013. |
| 19353687 | Background | Biglan KM, Voss TS, Deuel LM, Miller D, Eason S, Fagnano M, George BP, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Dorsey ER. Telemedicine for the care of nursing home residents with Parkinson's disease. Mov Disord. 2009 May 15;24(7):1073-6. doi: 10.1002/mds.22498. |
| 20533449 | Background | Dorsey ER, Deuel LM, Voss TS, Finnigan K, George BP, Eason S, Miller D, Reminick JI, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Biglan KM. Increasing access to specialty care: a pilot, randomized controlled trial of telemedicine for Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1652-9. doi: 10.1002/mds.23145. |
| 28840919 | Derived | Korn RE, Wagle Shukla A, Katz M, Keenan HT, Goldenthal S, Auinger P, Zhu W, Dodge M, Rizer K, Achey MA, Byrd E, Barbano R, Richard I, Andrzejewski KL, Schwarz HB, Dorsey ER, Biglan KM, Kang G, Kanchana S, Rodriguez R, Tanner CM, Galifianakis NB. Virtual visits for Parkinson disease: A multicenter noncontrolled cohort. Neurol Clin Pract. 2017 Aug;7(4):283-295. doi: 10.1212/CPJ.0000000000000371. |
| Withdrawal by Subject |
|
| Protocol Violation |
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| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Number | 95% Confidence Interval | units on a scale | Baseline and 6 months |
|
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|
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| Secondary | Acceptability | - The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%) | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Feasibility (Descriptive) | Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall. | Posted | Number | percentage of visits | 6 months |
|
|
|
| Secondary | Percentage of Patients Who Felt That the Recommendations Improved Their Health | Posted | Number | percentage of participants | 6 months |
|
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|
| 0 |
| 277 |
| 0 |
| 277 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |