Clinical trial NCT06638632: Decision Aid for Dementia Therapies
Official title: Helping Patients, Families, and Clinicians Make Shared Decisions About Therapies for Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Decision Aids
Keywords: Lecanemab
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Development of a decision aid based on international standards and user-centered design.
timeFrame: From enrollment to the final development of a decision aid at the end of year 1 (11 months after enrollment)
measure: Conduct a qualitative decision needs assessment of pharmacologic therapies for dementia.
timeFrame: From enrollment to the final development of a decision aid at the end of year 1 (11 months after enrollment)
Secondary outcomes:
measure: Pilot Feasability
timeFrame: From enrollment at start of year 2 to the end of year 2
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Dan Matlock, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.