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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Interdisciplinary Visit

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite score on self-efficacy scale	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.	Baseline, 3 months after interdisciplinary or standard clinic visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total weekly minutes exercised as measured by patient engagement survey.	Investigator developed patient engagement survey	Baseline, 3 months after interdisciplinary or standard care visit
Change in caregiver burden score on Zarit Burden Interview scale	Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.	Baseline, 3 months after interdisciplinary or standard care visit
Number of skilled therapy visits as reported by participant	Number of skilled therapy visits as reported by participant	Baseline, 3 months after interdisciplinary or standard care visit
Number of hospitalizations as reported by participant and medical record review	Number of hospitalizations 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	Number of ER visits as reported by participant and medical record review	Baseline, 3-6 months after interdisciplinary or standard care visit
Number of falls as reported by participant	Number of falls as reported by participant	Baseline, 3 months after interdisciplinary or standard care visit
Number of contraindicated medication combinations as determined by medical record review	Number of contraindicated medication combinations as determined by medical record review	Baseline, 3-6 months after interdisciplinary or standard care visit

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kyle Mitchell, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: patient engagement; interdisciplinary care; preventative care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Pro00105281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No