A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease (GROUP-PD)
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Purpose
To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease.
| Condition |
|---|
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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). |
- 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 |
|---|
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1
Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format.
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|
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).
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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 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.
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| 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 |
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 May 22, 2013