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

NCT06446505 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-06-06

No results posted yet for this study

Summary

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

Conditions

  • Parkinson Disease

Interventions

OTHER

Deep Brain Stimulation Decision Aid

An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michelle E Fullard, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446505 on ClinicalTrials.gov