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

NCT00528086 | Completed DMC

• 1 other identifier: RSRB00019885
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease; Parkinson's Disease Patient Caregivers

Keywords

Group visits

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Parkinson Foundation: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14618, United States

Location

Related Publications (34)

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MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 25, 2010

Record last verified: 2010-05

Locations

US (1)