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Completed

NCT Number: NCT04555720

The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease

The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room.

Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.

This study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Health Behavior Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Patient Acceptance of Health Care Patient Participation Synucleinopathies Treatment Adherence and Compliance

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Parkinson's Disease over the age of 30,
  • Caregiver willing to also participate.
  • Must be able to provide consent.

Exclusion criteria

-Atypical Parkinsonism

Treatment and study plan

Interdisciplinary Visit

Behavioral

If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.

Primary outcomes

  1. Change in Composite Score on Self-efficacy Scale

    Time frame: Baseline, 3 months after interdisciplinary or standard clinic visit

    Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.

Secondary outcomes

  1. Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.

    Time frame: Baseline, 3 months after interdisciplinary or standard care visit

    Investigator developed patient engagement survey

  2. Change in Caregiver Burden Score on Zarit Burden Interview Scale

    Time frame: Baseline, 3 months after interdisciplinary or standard care visit

    Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.

  3. Number of Skilled Therapy Visits as Reported by Participant

    Time frame: Baseline, 3 months after interdisciplinary or standard care visit

    Number of skilled therapy visits as reported by participant

  4. Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review

    Time frame: Baseline, 3-6 months after interdisciplinary or standard care visit

    Number of participants with a hospitalization as reported by participant and medical record review

  5. Number of Participants With an ER Visit as Reported by Participant and Medical Record Review

    Time frame: Baseline, 3-6 months after interdisciplinary or standard care visit

    Number of participants with an ER visit as reported by participant and medical record review

  6. Number Participants With a Fall as Reported by Participant and Medical Record Review

    Time frame: Baseline, 3 months after interdisciplinary or standard care visit

    Number participants with a fall as reported by Participant and Medical Record Review

  7. Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review

    Time frame: Baseline, 3-6 months after interdisciplinary or standard care visit

    Number of participants with a contraindicated medication combination as determined by medical record review

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Aug 13, 2024

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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