Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
Purpose
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
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado
Exclusion Criteria
- Atypical Parkinsonism - Diagnosis of Dementia
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Early Decision Aid |
Participants will receive the Decision Aid at baseline. |
|
|
Active Comparator Delayed Decision Aid |
Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process. |
|
Recruiting Locations
Aurora, Colorado 80045
More Details
- NCT ID
- NCT06446505
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver