Remote Access to Care, Everywhere, for Parkinson Disease

Parkinson Disease Clinical Trial

— RACE-PD  

Official title:

Remote Access to Care, Everywhere: Using Telemedicine to Deliver Patient-centered Care to Patients With Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02144220
• Other study ID #: RSRB-50627
• Status: Active, not recruiting
• Phase: N/A
• First received: May 19, 2014
• Last updated: February 18, 2016
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 287
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 120 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Virtual care visit
Video-conferencing visit with a Parkinson disease specialist

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California San Francisco/San Francisco VA Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	The Davis Phinney Foundation for Parkinson's

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. Epub 2006 Nov 2. — View 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. — View 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. Review. — View 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. — View 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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	The percent of telemedicine visits completed as scheduled. (Goal >80%); The percent of visits in which the investigators were satisfied/very satisfied with the care they were able to provide remotely. (Goal >80%)	6 months	No
Primary	Impact	The impact on Quality of life (QoL) as measured by the change in PDQ-39 from baseline to 6 months.; Summary of recommendations following the telemedicine visit; Adherence to recommendations (>80%) and perceived utility of recommendations at 6 months.	6 months	No
Primary	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	No
Secondary	Feasibility (Descriptive)	Descriptive statistics of reasons for missed or delayed visits and reasons for investigators' comfort and lack of comfort.; The proportion of telemedicine visits at each site where investigators felt confident/very confident in their assessments.	6 months	No
Secondary	Impact of recommendations	- The changes in PDQ-39 prior to and 6 months after the telemedicine visit amongst high adherers (those who follow at least 50% of the recommendations provided) versus the low adherers (those who follow less than 50% of the recommendations provided)	6 months	No