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

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

Detailed Description
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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.

Official Title
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A Single Center, Randomized Controlled, Pilot Study Comparing Group Visits Versus Routine Clinical Care for Participants With Parkinson's Disease (PD).

Conditions
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Parkinson's Disease, Parkinson's Disease Patient Caregivers

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format. | |
| 2<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group visits