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

NCT04555720 | Completed Results DMC

• 1 other identifier: Pro00105281
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

interdisciplinary care; patient engagement; preventative care

Outcome Measures

Primary Outcomes (1)

• 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 6, Maximum score is 60. Higher score is a better outcome.

  Baseline, 3 months after interdisciplinary or standard clinic visit

Secondary Outcomes (7)

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

  Baseline, 3 months after interdisciplinary or standard care visit

• Change in Caregiver Burden Score on Zarit Burden Interview Scale

  Baseline, 3 months after interdisciplinary or standard care visit

• Number of Skilled Therapy Visits as Reported by Participant

  Baseline, 3 months after interdisciplinary or standard care visit

• 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 an ER Visit as Reported by Participant and Medical Record Review

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

Study Arms (2)

Interdisciplinary Care

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.

Interventions

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.

Interdisciplinary Care

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Atypical Parkinsonism

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Patient Participation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kyle Mitchell, MD
• Organization: Duke University Medical Center

kyle.mitchell@duke.edu

919-668-2879

Study Officials

• Kyle Mitchell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: February 3, 2021
• Primary Completion: September 28, 2021
• Study Completion: November 1, 2021
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)