VICA: A Virtual Care Assistant for Dementia Caregivers

Virtual Informal Care Assistant for Alzheimer'S-related Dementia (VICA): A Pilot Randomized Controlled Trial

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07779785
Lead Sponsor: Indiana UniversityOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Aug 17, 2026Estimated
Primary Completion Date: Feb 28, 2027Estimated
Completion Date: May 30, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Virtual Informal Care Assistant for Alzheimer'S-related Dementia (VICA): A Pilot Randomized Controlled Trial
Brief 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).
Detailed Description: VICA is a customized large-language-model-driven avatar that provides speech-to-speech and text conversational support grounded in the ABC (Aging Brain Care) collaborative dementia care model and the HABC-Monitor assessment. Informal caregivers randomized to VICA are encouraged to use the platform 3 times per week for approximately 20 minutes over 3 months; control participants use the Dementia Guide Expert education-only app on the same schedule. Outcomes include trial feasibility metrics (recruitment, retention, VICA acceptance via TAM-PEOU, usability via SUS, usage/engagement) and preliminary effect-size estimates for the Neuropsychiatric Inventory (NPI) total score (patient BPSD), NPI-Distress score, PHQ-9 (caregiver depression), and GAD-7 (caregiver anxiety), collected at baseline and months 1, 2, and 3.

Conditions

The medical conditions and diseases this study investigates.

Alzheimer Dementia (AD)
Caregiver Burden of People With Dementia

Interventions

The treatments and procedures being evaluated in this study.

VICA - Virtual Informal Care Assistant
Education only BPSD mobile app

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Eskanazi Health

Indianapolis, Indiana 46202, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Indiana UniversityOTHER
Collaborators

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