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Decision Aid for Dementia Therapies

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06638632
Enrollment
100
Registered
2024-10-15
Start date
2025-11-30
Completion date
2026-02-28
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Aids, Dementia

Keywords

Lecanemab

Brief summary

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

Interventions

BEHAVIORALDecision aid

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is an iterative, user-centered design process. Therefore, patients and care partners will receive iterations of the decision aid as updates are made to it.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Decisional ConflictFrom enrollment at start of year 2 to the end of year 2To 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 MakingFrom enrollment at start of year 2 to the end of year 2To 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-EfficacyFrom enrollment at start of year 2 to the end of year 2To 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

Countries

United States

Contacts

Primary ContactKaitlynn Walton, MPH
kaitlynn.walton@cuanschutz.edu303-724-7162
Backup ContactKate Noonan, MSW
kate.noonan@cuanschutz.edu303-618-2181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026