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

This study has been completed.
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00528086
First received: September 7, 2007
Last updated: May 24, 2010
Last verified: May 2010
  Purpose

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


Condition
Parkinson's Disease
Parkinson's Disease Patient Caregivers

Study Type: Observational
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).

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528086

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
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
  More Information

Publications:

Responsible Party: E. Ray Dorsey, MD, MBA, University of Rochester
ClinicalTrials.gov Identifier: NCT00528086     History of Changes
Other Study ID Numbers: RSRB00019885
Study First Received: September 7, 2007
Last Updated: May 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Group visits

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 28, 2014