NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Indiana University
Conditions: Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Interventions: VICA - Virtual Informal Care Assistant, Education only BPSD mobile app
Countries: United States
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).
Sex: ALL
Age: 21 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Indianapolis, Indiana, United States