Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT06446505
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Deep Brain Stimulation Decision Aid — OTHERAn online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.
Study Details
The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are: * Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery? * Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision? Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid. Participants will: * Receive the decision aid at the beginning of the evaluation process or towards the end * Complete surveys at 5 visits (remote or in-person) over approximately 6 months
Key Dates
- Start date
- Jun 30, 2024
- Status verified
- Jun 2024
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 42 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Early Decision AidParticipants will receive the Decision Aid at baseline.
- Active Comparator: Delayed Decision AidParticipants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.
Primary Outcome Measure
Acceptability tool from the Ottawa Hospital Research Institute [ Time Frame: Baseline ]
Central Contacts
- Michelle E Fullard, MD3037242194
- Erika Shelton3037244644
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | Michelle E Fullard, MD (PRINCIPAL_INVESTIGATOR) |
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