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NCT Number: NCT06638632

Decision Aid for Dementia Therapies

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision aid

Behavioral

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

Primary outcomes

  1. 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

  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/

  3. 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 contacts

Contact information is provided by the study sponsor or research team.

Kaitlynn Walton, MPH

CONTACT

[email protected]

303-724-7162

Kate Noonan, MSW

CONTACT

[email protected]

303-618-2181

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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