Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144220
Recruitment Status : Completed
First Posted : May 21, 2014
Results First Posted : January 9, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Davis Phinney Foundation
Information provided by (Responsible Party):
Ray Dorsey, University of Rochester

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Feasibility [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 6 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144220


Locations
Layout table for location information
United States, California
University of California San Francisco/San Francisco VA Medical Center
San Francisco, California, United States
United States, Florida
University of Florida
Gainesville, Florida, United States, 32607
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Davis Phinney Foundation
Investigators
Layout table for investigator information
Principal Investigator: E. Ray Dorsey, MD, MBA University of Rochester
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Ray Dorsey, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02144220    
Other Study ID Numbers: RSRB-50627
First Posted: May 21, 2014    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: February 23, 2017
Last Verified: January 2017
Keywords provided by Ray Dorsey, University of Rochester:
Telemedicine
Virtual care visit
Remote visit
Video-conferencing
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases