Decision Aid for Dementia Therapies

September 12, 2025 updated by: University of Colorado, Denver

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decision Aid
Participants provide feedback on the development of a decision aid for dementia therapies.
Behavioral: Decision aid
Patients with dementia and care partners will receive an iteration of the decision aid and provide feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment at start of year 2 to the end of year 2
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/
From enrollment at start of year 2 to the end of year 2
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
From enrollment at start of year 2 to the end of year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pilot Feasability
Time Frame: From enrollment at start of year 2 to the end of year 2
A single-arm clinical trial (pilot study) of a decision aid intervention on patients and their clinicians considering pharmacologic therapy for dementia, to determine a) the feasibility and acceptability of a decision aid, and b) its preliminary efficacy on knowledge, decision conflict, and other implementation outcomes.
From enrollment at start of year 2 to the end of year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Dan Matlock, MD, MPH, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0866
  • NIA Grant#: R21AG088955 (Other Grant/Funding Number: NIA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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