Recruiting

Decision Aid

Sponsor:

University of Colorado, Denver

Code:

NCT06446505

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation Decision Aid

Study Details

Brief 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

Study ID

NCT06446505

Start date

Jun, 2024

Status verified date

Jun, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Acceptability tool from the Ottawa Hospital Research Institute [ Time Frame: Baseline ]
  • Acceptability tool from the Ottawa Hospital Research Institute [ Time Frame: 2 weeks after decision for deep brain stimulation surgery ]
  • Decisional Conflict Scale (DCS) [ Time Frame: Baseline ]
  • Decisional Conflict Scale (DCS) [ Time Frame: 1 Month ]
  • Decisional Conflict Scale (DCS) [ Time Frame: 3 Months ]
  • Decisional Conflict Scale (DCS) [ Time Frame: 2 weeks after decision for deep brain stimulation surgery ]
  • Decisional Conflict Scale (DCS) [ Time Frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery ]

Central Contacts and Locations

Central contacts

Michelle E Fullard, MD

3037242194michelle.fullard@cuanschutz.edu

Erika Shelton

3037244644erika.shelton@cuanschutz.edu

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Michelle E Fullard

303-724-2194michelle.fullard@cuanschutz.edu

Erika Shelton

3037244644erika.shelton@cuanschutz.edu

Principal Investigator:

Michelle E Fullard, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 6, 2024

Last verified

Jun, 2024

Keywords

  • Deep Brain Stimulation
  • Decision Aid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-06-06.