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

NCT ID: NCT00528086

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-08-31

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.

Conditions

Parkinson's Disease; Parkinson's Disease Patient Caregivers

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Parkinson Foundation

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

University of Rochester

Principal Investigators

E. Ray Dorsey, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Kevin Biglan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Fred Marshall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

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Other Identifiers

RSRB00019885

Identifier Type: -

Identifier Source: org_study_id