A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease (GROUP-PD)
To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease.
Parkinson's Disease Patient Caregivers
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Single Center, Randomized Controlled, Pilot Study Comparing Group Visits Versus Routine Clinical Care for Participants With Parkinson's Disease (PD).|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528086
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14618|
|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|