Back to resultsThe Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interdisciplinary Visit
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring interdisciplinary care, patient engagement, preventative care
Eligibility 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
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interdisciplinary Care
Standard of Care
Arm Description
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.
If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in total weekly minutes exercised as measured by patient engagement survey.
Investigator developed patient engagement survey
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.
Number of skilled therapy visits as reported by participant
Number of skilled therapy visits as reported by participant
Number of hospitalizations as reported by participant and medical record review
Number of hospitalizations as reported by participant and medical record review
Number of ER visits as reported by participant and medical record review
Number of ER visits as reported by participant and medical record review
Number of falls as reported by participant
Number of falls as reported by participant
Number of contraindicated medication combinations as determined by medical record review
Number of contraindicated medication combinations as determined by medical record review
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04555720
Brief Title
The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
Official Title
The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
interdisciplinary care, patient engagement, preventative care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interdisciplinary Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in composite score on self-efficacy scale
Description
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.
Time Frame
Baseline, 3 months after interdisciplinary or standard clinic visit
Secondary Outcome Measure Information:
Title
Change in total weekly minutes exercised as measured by patient engagement survey.
Description
Investigator developed patient engagement survey
Time Frame
Baseline, 3 months after interdisciplinary or standard care visit
Title
Change in caregiver burden score on Zarit Burden Interview scale
Description
Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.
Time Frame
Baseline, 3 months after interdisciplinary or standard care visit
Title
Number of skilled therapy visits as reported by participant
Description
Number of skilled therapy visits as reported by participant
Time Frame
Baseline, 3 months after interdisciplinary or standard care visit
Title
Number of hospitalizations as reported by participant and medical record review
Description
Number of hospitalizations as reported by participant and medical record review
Time Frame
Baseline, 3-6 months after interdisciplinary or standard care visit
Title
Number of ER visits as reported by participant and medical record review
Description
Number of ER visits as reported by participant and medical record review
Time Frame
Baseline, 3-6 months after interdisciplinary or standard care visit
Title
Number of falls as reported by participant
Description
Number of falls as reported by participant
Time Frame
Baseline, 3 months after interdisciplinary or standard care visit
Title
Number of contraindicated medication combinations as determined by medical record review
Description
Number of contraindicated medication combinations as determined by medical record review
Time Frame
Baseline, 3-6 months after interdisciplinary or standard care visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Mitchell, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
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