Clinical trial NCT02144220: Remote Access to Care, Everywhere, for Parkinson Disease
Official title: Remote Access to Care, Everywhere: Using Telemedicine to Deliver Patient-centered Care to Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Telemedicine
Virtual care visit
Remote visit
Video-conferencing
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Davis Phinney Foundation
First posted: 2014-05-21
Enrollment: 277
Sex: ALL
Minimum age (years): 30
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
measure: Change in Quality of Life as Measured by the PDQ-39 Assessment Tool
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Acceptability
timeFrame: 6 months
measure: Feasibility (Descriptive)
timeFrame: 6 months
measure: Percentage of Patients Who Felt That the Recommendations Improved Their Health
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco/San Francisco VA Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: E. Ray Dorsey, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.