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VICA: A Virtual Care Assistant for Dementia Caregivers

NCT07779785 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-21

No results posted yet for this study

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).

Conditions

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

Interventions

DEVICE

VICA - Virtual Informal Care Assistant

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.

DEVICE

Education only BPSD mobile app

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.

Sponsors & Collaborators

  • University of Notre Dame

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Malaz Boustani, MD, MPH · Indiana University School of Medicine, Center for Health Innovation and Implementation Science

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2027-02-28
Completion
2027-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07779785 on ClinicalTrials.gov