Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes

December 1, 2016 updated by: Ray Dorsey, University of Rochester

Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study

Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following:

  1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care;
  2. To show that such an approach can improve quality of life;
  3. To establish that the telemedicine can enhance the quality of care; and
  4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's "usual care" supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.

Study Type

Interventional

Enrollment (Actual)

210

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, 94143
        • University of California San Francisco
      • Sunnyvale, California, United States, 94083
        • The Parkinson's Institute and Clinical Center
    • Florida
      • Gainsville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Struthers Parkinson Center
      • Rochester, Minnesota, United States, 55905
        • The Mayo Clinic
    • New York
      • Manhasset, New York, United States, 11030
        • Northshore Long Island Jewish - Feinstein Institute
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Spokane, Washington, United States, 99202
        • Northwest Neurological, PLLC

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater
  • No better alternative explanation for the parkinsonism
  • Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing
  • Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine
  • Have a local care provider that the study team can contact
  • Live at home, in a senior housing complex, or assisted living facility
  • Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only)
  • Willing and able to provide informed consent
  • Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.

Exclusion Criteria:

  • Currently hospitalized
  • Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse).
  • Participation 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care and Educational Materials
Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
Experimental: Virtual Visits and Educational Materials
Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Other: Virtual Visits
Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone).
Other Names:
  • Telemedicine
  • Teleneurology
  • Video call
  • Video conferencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Virtual Visits for Parkinson Disease
Time Frame: One year
Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.
One year
Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39
Time Frame: Baseline to One year
Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.
Baseline to One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EQ-5D Index Value
Time Frame: baseline to one year
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).
baseline to one year
Change in Montreal Cognition Assessment
Time Frame: baseline to one year
We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.
baseline to one year
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA
Time Frame: baseline to one year
Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.
baseline to one year
Change in Patient Assessment of Chronic Illness Care
Time Frame: baseline to one year
We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.
baseline to one year
Minutes Spend on Last Parkinson's Disease Provider Visit
Time Frame: One year
One year
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB
Time Frame: baseline to one year
Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.
baseline to one year
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2
Time Frame: baseline to one year
Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.
baseline to one year
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3
Time Frame: baseline to one year
Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.
baseline to one year
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4
Time Frame: baseline to one year
Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.
baseline to one year

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

Patient-Centered Outcomes Research Institute
National Parkinson 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)

August 1, 2016

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-12-11-4701

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 Visits

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe