Remote Access to Care, Everywhere, for Parkinson Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Virtual care visit

• Registration Number: NCT02144220
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Primary Completion: 2016-08
• Study Completion: 2016-10
• Results First Submitted: 2016-11-10
• Results First Submitted QC: 2016-11-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Results First Posted: 2017-01-09
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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.)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual care visit	Virtual care visit	One-time virtual care visit for Parkinson disease.

Primary Outcome Measures

Name	Time	Method
Feasibility	6 months	The percent of telemedicine visits completed as scheduled. (Goal \>80%)
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

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

Trial Locations

Locations (3)

University of California San Francisco/San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States