A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease

Completed

• Conditions: Parkinson's Disease; Parkinson's Disease Patient Caregivers

• Registration Number: NCT00528086
• Lead Sponsor: University of Rochester

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-11
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-24
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	12 months

Trial Locations

Locations (1)

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