Decision Aid for Dementia Therapies

Not Applicable

Not yet recruiting

• Conditions: Dementia; Decision Aids

• Registration Number: NCT06638632
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Start: 2025-01
• Primary Completion: 2025-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Development of a decision aid based on international standards and user-centered design.	From enrollment to the final development of a decision aid at the end of year 1 (11 months after enrollment)	Prescriptively follows the Ottawa Decision Support Framework which assumes participants' decisional needs (e.g., knowledge, values, support) will affect decision quality, which then impacts subsequent outcomes such as emotions (e.g., regret, blame), behavior, and appropriate use of health services. International Patient Decision Aids Standard (IPDAS) identifies 12 decision quality domains important to developing decision aids. Score on the number of IPDAS criteria included in the final decision aid will be assessed. Higher score indicates better quality of decision aid.
Conduct a qualitative decision needs assessment of pharmacologic therapies for dementia.	From enrollment to the final development of a decision aid at the end of year 1 (11 months after enrollment)	Qualitative assessment conducted through semi-structured qualitative interviews with up to 40 patients and dyads, up to 40 caregivers, and up to 20 clinicians.

Secondary Outcome Measures

Name	Time	Method
Pilot Feasability	From enrollment at start of year 2 to the end of year 2	A single-arm clinical trial (pilot study) of a decision aid intervention on patients and their clinicians considering pharmacologic therapy for dementia, to determine a) the feasibility and acceptability of a decision aid, and b) its preliminary efficacy on knowledge, decision conflict, and other implementation outcomes.