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

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT02144220
• Collaborator: Davis Phinney Foundation (Other)
• Enrollment: 277
• Locations: 3
• Arm: 1
• Duration (Months): 31
• Patients Per Site: 92.3
• Patients Per Site Per Month: 3

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Virtual care visit	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 277 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Remote Access to Care, Everywhere: Using Telemedicine to Deliver Patient-centered Care to Patients With Parkinson Disease
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual care visit One-time virtual care visit for Parkinson disease.	Other: Virtual care visit; Video-conferencing visit with a Parkinson disease specialist; Other Names: Telemedicine visit Virtual house call

Outcome Measures

Primary Outcome Measures

1. Feasibility [6 months]

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

2. 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 Outcome Measures

1. 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%)

2. Feasibility (Descriptive) [6 months]

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

3. Percentage of Patients Who Felt That the Recommendations Improved Their Health [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco/San Francisco VA Medical Center	San Francisco	California	United States
2	University of Florida	Gainesville	Florida	United States	32607
3	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• Davis Phinney Foundation

Investigators

• Principal Investigator: E. Ray Dorsey, MD, MBA, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Epub 2006 Nov 2.
• 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.
• 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. Review.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Ray Dorsey, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT02144220
• Other Study ID Numbers: RSRB-50627
• First Posted: May 21, 2014
• Last Update Posted: Feb 23, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Ray Dorsey, Professor, University of Rochester: Telemedicine; Virtual care visit; Remote visit; Video-conferencing
• Additional relevant MeSH terms: Parkinson Disease

Study Results

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 Detail	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.

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Period Title: Overall Study
STARTED	277
COMPLETED	258
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Overall Participants	277
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (9.1)
Gender (Count of Participants)
Female	138 49.8%
Male	139 50.2%
Region of Enrollment (participants) [Number]
United States	277 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility
Description	The percent of telemedicine visits completed as scheduled. (Goal >80%)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Measure Participants	277
Number [percentage of visits]	91

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Measure Participants	258
Number (95% Confidence Interval) [units on a scale]	0.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Virtual Care Visit
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.39
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Measure Participants	258
Number [percentage of participants]	74 26.7%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Measure Participants	258
Number [percentage of visits]	94

5. Secondary Outcome

Title	Percentage of Patients Who Felt That the Recommendations Improved Their Health
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
Measure Participants	258
Number [percentage of participants]	56 20.2%

Adverse Events

Arm/Group Title	Virtual Care Visit
Arm/Group Description	One-time virtual care visit for Parkinson disease. Virtual care visit: Video-conferencing visit with a Parkinson disease specialist
All Cause Mortality
	Virtual Care Visit
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Virtual Care Visit
	Affected / at Risk (%)	# Events
Total	0/277 (0%)
Other (Not Including Serious) Adverse Events
	Virtual Care Visit
	Affected / at Risk (%)	# Events
Total	0/277 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.