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 — OTHER
    An 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 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.

Primary Outcome Measure

Acceptability tool from the Ottawa Hospital Research Institute [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado AnschutzAuroraColorado80045
Michelle E Fullard
303-724-2194
Erika Shelton
3037244644
Michelle E Fullard, MD (PRINCIPAL_INVESTIGATOR)

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