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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555720
• Other study ID #: Pro00105281
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 1, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of falls as reported by participant	Number of falls as reported by participant	Baseline, 3 months after interdisciplinary or standard care visit
Secondary	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