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Clinical Trials/NCT06638632
NCT06638632
Not Yet Recruiting
N/A

Helping Patients, Families, and Clinicians Make Shared Decisions About Therapies for Dementia

University of Colorado, Denver1 site in 1 country100 target enrollmentNovember 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dementia
Sponsor
University of Colorado, Denver
Enrollment
100
Locations
1
Primary Endpoint
Decisional Conflict
Status
Not Yet Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The purpose of this study is to develop a decision aid to support patients and families making decisions about medications for dementia.

Registry
clinicaltrials.gov
Start Date
November 1, 2025
End Date
February 28, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • UCHealth patient
  • Ages 18 y/o and above
  • Documented neurocognitive deficits suggestive of mild cognitive impairment or early dementia as determined by their treating clinician.
  • English or Spanish speaking
  • Ages 18 y/o and above
  • Identified by the study participant as the person who helps the most with their medical care outside the hospital or clinic.
  • English or Spanish speaking
  • Clinicians:
  • Neurologists, primary care clinicians, pharmacists, or psychologists involved in dementia decision-making.
  • English or Spanish speaking

Exclusion Criteria

  • Not English or Spanish-speaking
  • Neurocognitive deficits suggestive of moderate or severe cognitive impairment or late stage dementia.
  • Not able to consent for themselves
  • Ages 17 y/o and below
  • Not English or Spanish-speaking
  • Clinicians:
  • Neurologists, primary care clinicians, pharmacists, or psychologists involved in dementia decision-making.
  • English or Spanish-speaking

Outcomes

Primary Outcomes

Decisional Conflict

Time Frame: From enrollment at start of year 2 to the end of year 2

To access the preliminary efficacy on decisional conflict including personal perceptions of uncertainty in choosing options, factors that contribute to feelings of uncertainty and effective decision making. Decisional Conflict Scale - Higher numbers mean more uncertainty. O'Connor, A. M. (1995). Validation of a decisional conflict scale. Medical decision making, 15(1), 25-30. https://decisionaid.ohri.ca/docs/develop/User\_Manuals/UM\_Decisional\_Conflict.pdf

Shared Decision Making

Time Frame: From enrollment at start of year 2 to the end of year 2

To determine the extent that health care providers engage with patients as a part of their shared decision making, specifically looking at the discussion of treatment options and their pros and cons as well as the patient's preferences. Shared Decision Making Process Scale - Higher numbers mean more shared decision making. https://mghdecisionsciences.org/tools-training/sdm-process-survey/

Decisional Self-Efficacy

Time Frame: From enrollment at start of year 2 to the end of year 2

To determine the patient's perception of their self-efficacy in decision making including measuring their self-confidence in their ability to make decisions. Decision Self-Efficacy Scale where higher numbers mean they patient has a higher perception of self-efficacy. https://decisionaid.ohri.ca/docs/develop/Tools/Decision\_SelfEfficacy.pdf

Study Sites (1)

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