Decision Aid for Dementia Therapies

Not Applicable

Not yet recruiting

• Conditions: Dementia; Decision Aids

• Registration Number: NCT06638632
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-16
• Study Start: 2025-11-01
• Primary Completion: 2026-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients:

• 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

Caregiver:

• 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

Patients:

• Not English or Spanish-speaking
• Neurocognitive deficits suggestive of moderate or severe cognitive impairment or late stage dementia.
• Not able to consent for themselves

Caregiver:

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Decisional Conflict	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	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	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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States