A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease (GROUP-PD)

May 24, 2010 updated by: University of Rochester

A Single Center, Randomized Controlled, Pilot Study Comparing Group Visits Versus Routine Clinical Care for Participants With Parkinson's Disease (PD).

To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease.

Study Overview

Status

Completed

Conditions

Detailed Description

To establish the feasibility and to estimate the benefit of group visits for individuals with PD and their caregivers. The feasibility will be assessed by the ability to enroll and retain (measured by number of individuals who complete the 12-month study and at least half the study visits) ~40 individuals in the pilot trial. The responsiveness of the following different outcomes to group visits will be assessed during the pilot trial: quality of life, patient satisfaction, depression, caregiver burden, resource utilization, and disease progression. The primary outcome measure for efficacy will be a comparison of the change in the Parkinson's Disease Questionnaire-39 from baseline to 12 months in the control (routine care) and intervention (group visit) groups.

Study Type

Observational

Enrollment (Anticipated)

40

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
    • New York
      • Rochester, New York, United States, 14618
        • University of Rochester

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study participants will be recruited from Drs. Dorsey, Biglan, and Marshall's patient populations from the Parkinson disease clinic at the University of Rochester Neurology group.

Description

Inclusion Criteria:

  • Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no alternative explanation for the etiology of the symptoms
  • Willing and able to provide informed consent and to participate actively in group visits and complete study activities

Exclusion Criteria:

  • Cognitive impairment, psychiatric disorder, or history of or current clinically significant substance abuse that in the investigator's judgment could interfere in the conduct of group visits or with study participation.

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

Cohorts and Interventions

Group / Cohort
1
Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format.
2
Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in standard of care format (one-on-one physician-patient visits).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The feasibility (based on the ability to enroll and retain 40 individuals) and benefit (based on the 12-month change in PDQ-39) of group visits for individuals with Parkinson disease and their caregivers.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

National Parkinson Foundation

Investigators

  • Principal Investigator: E. Ray Dorsey, MD, MBA, University of Rochester
  • Principal Investigator: Kevin Biglan, MD, MPH, University of Rochester
  • Principal Investigator: Fred Marshall, MD, 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

September 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

May 25, 2010

Last Update Submitted That Met QC Criteria

May 24, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00019885

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.

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