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OpenTrials
Completed

NCT Number: NCT00528086

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

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

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14618, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Parkinson Foundation

Registry information

Official study title

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

Acronym: GROUP-PD

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2007
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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