RecruitingRecruiting
Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
NCT06446505 · University of Colorado, Denver
In plain English
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Official title
Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial
About this study
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
Eligibility criteria
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
Enrollment target: 42 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06
Estimated completion: 2026-07
Last updated: 2024-06-06
Interventions
Other: Deep Brain Stimulation Decision Aid
Primary outcomes
- • Acceptability tool from the Ottawa Hospital Research Institute (Baseline)
- • Acceptability tool from the Ottawa Hospital Research Institute (2 weeks after decision for deep brain stimulation surgery)
- • Decisional Conflict Scale (DCS) (Baseline)
Sponsor
University of Colorado, Denver · other
With: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Contacts & investigators
ContactMichelle E Fullard, MD · contact · michelle.fullard@cuanschutz.edu · 3037242194
ContactErika Shelton · contact · erika.shelton@cuanschutz.edu · 3037244644
InvestigatorMichelle E Fullard, MD · principal_investigator, University of Colorado, Denver
All locations (1)
University of Colorado AnschutzRecruiting
Aurora, Colorado, United States