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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: Interdisciplinary Visit

• Registration Number: NCT04555720
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2021-02-03
• Primary Completion: 2021-09-28
• Study Completion: 2021-11-01
• Status Verified: 2022-04
• Results First Submitted: 2023-07-11
• Results First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Results First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

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

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Exclusion Criteria

-Atypical Parkinsonism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interdisciplinary Care	Interdisciplinary Visit	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 participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.

Primary Outcome Measures

Name	Time	Method
Change in Composite Score on Self-efficacy Scale	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 Outcome Measures

Name	Time	Method
Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review	Baseline, 3-6 months after interdisciplinary or standard care visit	Number of participants with a hospitalization as reported by participant and medical record review
Change in Caregiver Burden Score on Zarit Burden Interview Scale	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.
Number of Participants With an ER Visit as Reported by Participant and Medical Record Review	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
Number Participants With a Fall as Reported by Participant and Medical Record Review	Baseline, 3 months after interdisciplinary or standard care visit	Number participants with a fall as reported by Participant and Medical Record Review
Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.	Baseline, 3 months after interdisciplinary or standard care visit	Investigator developed patient engagement survey
Number of Skilled Therapy Visits as Reported by Participant	Baseline, 3 months after interdisciplinary or standard care visit	Number of skilled therapy visits as reported by participant
Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review	Baseline, 3-6 months after interdisciplinary or standard care visit	Number of participants with a contraindicated medication combination as determined by medical record review

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States