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

• ClinicalTrials.gov Identifier: NCT04555720
• Recruitment Status: Enrolling by invitation
• First Posted: September 21, 2020
• Last Update Posted: September 17, 2021
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 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: February 3, 2021
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: July 2022

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 [ 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 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. [ 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 hospitalizations as reported by participant and medical record review [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 3-6 months after interdisciplinary or standard care visit ]
   Number of contraindicated medication combinations as determined by medical record review

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Kyle Mitchell, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04555720
• Other Study ID Numbers: Pro00105281
• First Posted: September 21, 2020
• Last Update Posted: September 17, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

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