Clinical trial NCT04555720: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: interdisciplinary care
patient engagement
preventative care
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Composite Score on Self-efficacy Scale
timeFrame: Baseline, 3 months after interdisciplinary or standard clinic visit
Secondary outcomes:
measure: Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.
timeFrame: Baseline, 3 months after interdisciplinary or standard care visit
measure: Change in Caregiver Burden Score on Zarit Burden Interview Scale
timeFrame: Baseline, 3 months after interdisciplinary or standard care visit
measure: Number of Skilled Therapy Visits as Reported by Participant
timeFrame: Baseline, 3 months after interdisciplinary or standard care visit
measure: Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review
timeFrame: Baseline, 3-6 months after interdisciplinary or standard care visit
measure: Number of Participants With an ER Visit as Reported by Participant and Medical Record Review
timeFrame: Baseline, 3-6 months after interdisciplinary or standard care visit
measure: Number Participants With a Fall as Reported by Participant and Medical Record Review
timeFrame: Baseline, 3 months after interdisciplinary or standard care visit
measure: Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review
timeFrame: Baseline, 3-6 months after interdisciplinary or standard care visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kyle Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: