Not yet recruiting NCT06638632
Decision Aid for Dementia Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decision aid.
- Who it may be relevant to
- Registry conditions: Dementia, Decision Aids. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Helping Patients, Families, and Clinicians Make Shared Decisions About Therapies for Dementia
Overview
The purpose of this study is to develop a decision aid to support patients and families making decisions about medications for dementia.
Interventions
- Behavioral Decision aid
Patients with dementia and care partners will receive an iteration of the decision aid and provide feedback.
Primary outcome measures
- Decisional Conflict [Time frame: From enrollment at start of year 2 to the end of year 2]
- Shared Decision Making [Time frame: From enrollment at start of year 2 to the end of year 2]
- Decisional Self-Efficacy [Time frame: From enrollment at start of year 2 to the end of year 2]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Colorado — Aurora
Publications
- 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
- 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
Identifiers
NCT: NCT06638632 · 24-0866 · NIA Grant#: R21AG088955