Decision Aid for Dementia Therapies

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Dementia, Decision Aids

Being tested

Decision aid

Keywords

Lecanemab

Medical subject headings

Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Decision aidBehavioural

  Patients with dementia and care partners will receive an iteration of the decision aid and provide feedback.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Decisional Conflict

   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

   Measured: From enrollment at start of year 2 to the end of year 2

2. Shared Decision Making

   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/

   Measured: From enrollment at start of year 2 to the end of year 2

3. Decisional Self-Efficacy

   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

   Measured: From enrollment at start of year 2 to the end of year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Oct 2024
2. Study startNov 2025 (estimated)
3. Primary completionJan 2026 (estimated)
4. Study completion28 Feb 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for DementiaStudies of the same condition, open and under way.
• More trials run by University of Colorado, DenverThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.