Decision Aid for Dementia Therapies

NCT06638632 | Not Yet Recruiting

• 2 other identifiers: 24-0866NIA Grant#: R21AG088955
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dementia; Decision Aids

Keywords

Lecanemab

Outcome Measures

Primary Outcomes (3)

• 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

  From enrollment at start of year 2 to the end of year 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/

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

• 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

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

Study Arms (1)

Decision Aid

EXPERIMENTAL

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

Behavioral: Decision aid

Interventions

Decision aid BEHAVIORAL

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

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 21088131 BACKGROUND

• 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.

  PMID: 36449413 BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dan Matlock, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlynn Walton, MPH

CONTACT

303-724-7162; kaitlynn.walton@cuanschutz.edu

Kate Noonan, MSW

CONTACT

303-618-2181; kate.noonan@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 28, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)