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Remote Access to Care, Everywhere, for Parkinson Disease (RACE-PD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual care visit
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring Telemedicine, Virtual care visit, Remote visit, Video-conferencing

Eligibility Criteria

30 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Francisco/San Francisco VA Medical Center
  • University of Florida
  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual care visit

Arm Description

One-time virtual care visit for Parkinson disease.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2014
Last Updated
January 6, 2017
Sponsor
University of Rochester
Collaborators
Davis Phinney Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02144220
Brief Title
Remote Access to Care, Everywhere, for Parkinson Disease
Acronym
RACE-PD
Official Title
Remote Access to Care, Everywhere: Using Telemedicine to Deliver Patient-centered Care to Patients With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Davis Phinney Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: To demonstrate the feasibility of conducting remote evaluations of patients with Parkinson disease nationally; 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 To assess the long-term acceptability to patients in receiving ongoing care remotely via telemedicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Telemedicine, Virtual care visit, Remote visit, Video-conferencing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual care visit
Arm Type
Experimental
Arm Description
One-time virtual care visit for Parkinson disease.
Intervention Type
Other
Intervention Name(s)
Virtual care visit
Other Intervention Name(s)
Telemedicine visit, Virtual house call
Intervention Description
Video-conferencing visit with a Parkinson disease specialist
Primary Outcome Measure Information:
Title
Feasibility
Description
The percent of telemedicine visits completed as scheduled. (Goal >80%)
Time Frame
6 months
Title
Change in Quality of Life as Measured by the PDQ-39 Assessment Tool
Description
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
Secondary Outcome Measure Information:
Title
Acceptability
Description
- 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
Title
Feasibility (Descriptive)
Description
Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.
Time Frame
6 months
Title
Percentage of Patients Who Felt That the Recommendations Improved Their Health
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Ray Dorsey, MD, MBA
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco/San Francisco VA Medical Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23479138
Citation
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.
Results Reference
background
PubMed Identifier
24790799
Citation
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.
Results Reference
background
PubMed Identifier
17082464
Citation
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.
Results Reference
background
PubMed Identifier
23616157
Citation
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.
Results Reference
background
PubMed Identifier
21832214
Citation
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.
Results Reference
background
PubMed Identifier
23054239
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19353687
Citation
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.
Results Reference
background
PubMed Identifier
20533449
Citation
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.
Results Reference
background
PubMed Identifier
28840919
Citation
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.
Results Reference
derived

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Remote Access to Care, Everywhere, for Parkinson Disease

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