Clinical trial NCT00528086: A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease
Official title: A Single Center, Randomized Controlled, Pilot Study Comparing Group Visits Versus Routine Clinical Care for Participants With Parkinson's Disease (PD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Parkinson's Disease Patient Caregivers
Keywords: Group visits
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Parkinson Foundation
First posted: 2007-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: E. Ray Dorsey, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Kevin Biglan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Fred Marshall, MD
role: PRINCIPAL_INVESTIGATOR
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