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NCT07779785
VICA: A Virtual Care Assistant for Dementia Caregivers
Conditions: Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Indiana University
Location: Eskanazi Health Indianapolis Indiana
Summary
This pilot randomized controlled trial evaluates the feasibility and preliminary efficacy of VICA, an AI-powered virtual care assistant that delivers evidence-based education, symptom monitoring, and coaching to informal caregivers of people living with Alzheimer's disease and related dementias (ADRD). Sixty caregiver-patient dyads will be randomized 1:1 to VICA or an attention-control education app (Dementia Guide Expert) for 3 months. The study will assess recruitment, VICA acceptance/usability, and engagement (Aim 1), and estimate effect sizes for reducing patient behavioral and psychological symptoms of dementia (BPSD) and caregiver distress (Aim 2).
Eligibility Criteria
Inclusion Criteria: Patient
* Age ≥ 65 years
* Community-dwelling
* Diagnosed with ADRD
* Clinical notes indicate behavioral and psychological symptoms of dementia (BPSD) Inclusion Criteria: Informal Caregiver
* Age ≥ 21 years
* Self-identified informal caregiver of a community-dwelling patient diagnosed with ADRD
* Provides ≥ 10 hours/week of care to the patient with ADRD
* Regular access to a computer and/or smart device with internet
* English-literate; assessed as "adequate" on the Single Item Literacy Screener
Exclusion Criteria: Patient
* Life expectancy less than 6 months
Exclusion Criteria: Informal Caregiver
* Clinician-reported cognitive impairment
* Clinician-reported severe mental illness or substance use disorder
* Clinician-reported life expectancy of less than 6 months
* Unable to provide informed consent
Source: ClinicalTrials.gov (NCT07779785). StuddyBuddy aggregates publicly available trial information.