Decision Aid for Dementia Therapies

NCT ID: NCT06638632

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-02-28

Brief Summary

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

Detailed Description

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Conditions

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Dementia Decision Aids

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Decision Aid

Participants provide feedback on the development of a decision aid for dementia therapies.

Group Type EXPERIMENTAL

Decision aid

Intervention Type BEHAVIORAL

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

Interventions

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Decision aid

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Matlock, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Central Contacts

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Kaitlynn Walton, MPH

Role: CONTACT

303-724-7162

Kate Noonan, MSW

Role: CONTACT

303-618-2181

Facility Contacts

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Kaitlynn Walton, MPH

Role: primary

303-724-7162

Kate Noonan

Role: backup

References

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Elwyn G, Frosch D, Volandes AE, Edwards A, Montori VM. Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions. Med Decis Making. 2010 Nov-Dec;30(6):701-11. doi: 10.1177/0272989X10386231. Epub 2010 Nov 18.

Reference Type BACKGROUND
PMID: 21088131 (View on PubMed)

van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.

Reference Type BACKGROUND
PMID: 36449413 (View on PubMed)

Other Identifiers

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NIA Grant#: R21AG088955

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-0866

Identifier Type: -

Identifier Source: org_study_id

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