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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04555720
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Interdisciplinary Visit	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
• Actual Study Start Date: Feb 3, 2021
• Actual Primary Completion Date: Sep 28, 2021
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interdisciplinary Care 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.	Behavioral: 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 participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.
No Intervention: Standard of Care If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.

Outcome Measures

Primary Outcome Measures

1. 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 1, Maximum score is 10. Higher score is a better outcome.

Secondary Outcome Measures

1. 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

2. 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.

3. 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

4. Number of hospitalizations as reported by participant and medical record review [Baseline, 3-6 months after interdisciplinary or standard care visit]

   Number of hospitalizations as reported by participant and medical record review

5. Number of ER visits as reported by participant and medical record review [Baseline, 3-6 months after interdisciplinary or standard care visit]

   Number of ER visits as reported by participant and medical record review

6. Number of falls as reported by participant [Baseline, 3 months after interdisciplinary or standard care visit]

   Number of falls as reported by participant

7. Number of contraindicated medication combinations as determined by medical record review [Baseline, 3-6 months after interdisciplinary or standard care visit]

   Number of contraindicated medication combinations as determined by medical record review

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Kyle Mitchell, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04555720
• Other Study ID Numbers: Pro00105281
• First Posted: Sep 21, 2020
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: interdisciplinary care; patient engagement; preventative care
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Apr 22, 2022