Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Deep Brain Stimulation Decision Aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06446505

K12AR084226 (U.S. NIH Grant/Contract)

23-2390

Details and patient eligibility

About

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

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Early Decision Aid

Experimental group

Description:

Participants will receive the Decision Aid at baseline.

Treatment:

Other: Deep Brain Stimulation Decision Aid

Delayed Decision Aid

Active Comparator group

Description:

Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Treatment:

Other: Deep Brain Stimulation Decision Aid