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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04555720
Other study ID # Pro00105281
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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