VICA: A Virtual Care Assistant for Dementia Caregivers

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07779785
Status
Not Yet Recruiting

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Conditions

  • Alzheimer Dementia (AD)
  • Caregiver Burden of People With Dementia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VICA - Virtual Informal Care Assistant — DEVICE
    An AI-powered avatar delivering conversational, speech-to-speech and text-based education, resource information, and symptom-monitoring support to informal caregivers of patients with Alzheimer's disease and related dementias (ADRD), grounded in the ABC collaborative dementia care model via a retrieval-augmented generation system.
  • Education only BPSD mobile app — DEVICE
    Access to Dementia Guide Expert, an existing free, education-only BPSD mobile app (ENGAGE-IL initiative, University of Illinois at Chicago), used on the same 3x/week, \~20 minute schedule for 3 months. No interactive coaching, assessment, or personalized response.

Study Details

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).

Key Dates

First listed
Aug 21, 2026
Start date
Aug 17, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
May 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental: VICA
    Access to the VICA AI-powered avatar platform for 3 months; caregivers encouraged to engage 3x/week for \~20 minutes per session. VICA delivers education, resource information, and symptom-monitoring (HABC-Monitor) grounded in the ABC collaborative dementia care model via a retrieval-augmented generation (RAG) system.
  • Active Comparator: Active Comparator: Attention Control
    Access to Dementia Guide Expert, an existing free, education-only BPSD mobile app (ENGAGE-IL initiative, University of Illinois at Chicago), used on the same 3x/week, \~20 minute schedule for 3 months. No interactive coaching, assessment, or personalized response.

Primary Outcome Measure

Neuropsychiatric Inventory (NPI) total score [ Time Frame: Baseline, 1, 2, and 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Eskanazi HealthIndianapolisIndiana46202-

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By research site
Eskanazi Health· Indianapolis, IN

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