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

January 6, 2017 updated by: Ray Dorsey, University of Rochester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
        • University of California San Francisco/San Francisco VA Medical Center
    • Florida
      • Gainesville, Florida, United States, 32607
        • University of Florida
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 months
The percent of telemedicine visits completed as scheduled. (Goal >80%)
6 months
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.
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
6 months
Feasibility (Descriptive)
Time Frame: 6 months
Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.
6 months
Percentage of Patients Who Felt That the Recommendations Improved Their Health
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Davis Phinney Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB-50627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Virtual care visit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe