VICA: A Virtual Care Assistant for Dementia Caregivers

NCT07779785 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB28255
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

behavioral and psychological symptoms of dementia; conversational AI; avatar; informal caregiver; digital therapeutic; ABC collaborative dementia care model

Outcome Measures

Primary Outcomes (7)

• Neuropsychiatric Inventory (NPI) total score

  A 12-domain caregiver-informant-rated measure of patient behavioral and psychological symptoms of dementia. Each domain is scored as frequency (1-4) times severity (1-3) if present, or 0 if absent. Domain scores are summed for a Total Score ranging 0-144; higher scores indicate more frequent and/or severe symptoms.

  Baseline, 1, 2, and 3 months

• Neuropsychiatric Inventory-Distress (NPI-D) Scale

  Derived from the same 12-domain NPI interview. For each domain in which a symptom is present, the caregiver rates how emotionally distressing that behavior is to them, from 0 (not at all) to 5 (very severely). Ratings are summed across domains for a total score of 0-60; higher scores indicate greater caregiver distress.

  Baseline, 1, 2, and 3 months

• Assessment completion rate

  Computed at 3 months

• Recruitment rate

  Recruitment rate computed monthly as # approached, # agreeing, and \# consenting, tracked continuously throughout the accrual period.

  up to 15 months

• Technology Acceptance Model-Perceived Ease of Use (TAM-PEOU)

  A 6-item caregiver self-report measure of perceived ease of use, each item rated on a 7-point scale from Extremely Disagree to Extremely Agree. Item scores are summed for a total ranging 6-42; higher scores indicate greater perceived ease of use. Intervention-arm participants rate the VICA platform; control-arm participants rate the Dementia Guide Expert app, using parallel-worded versions of the same instrument.

  Months 1, 2, 3

• System Usability Scale (SUS)

  A 10-item caregiver self-report measure of perceived usability, rated on a 5-point scale from Strongly Disagree to Strongly Agree, with alternating positively- and negatively-worded items. Using standard SUS scoring, item responses are converted and summed to a total ranging 0-100; higher scores indicate better usability. Intervention-arm participants rate the VICA platform; control-arm participants rate the Dementia Guide Expert app, using parallel-worded versions of the same instrument.

  Months 1, 2, 3

• VICA usage

  Server-recorded log-ins, session progress/completion, and conversation content, collected from the VICA intervention arm only. Not applicable to the attention control arm, which does not use the VICA platform.

  up to 12 weeks

Secondary Outcomes (2)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 1, 2, and 3 months

• Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Baseline, 1, 2, and 3 months

Study Arms (2)

Experimental: VICA

EXPERIMENTAL

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.

Device: VICA - Virtual Informal Care Assistant

Active Comparator: Attention Control

ACTIVE COMPARATOR

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.

Device: Education only BPSD mobile app

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.

Experimental: VICA

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.

Active Comparator: Attention Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Community-dwelling
• Diagnosed with ADRD
• 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

You may not qualify if:

• Life expectancy less than 6 months
• 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

Sponsors & Collaborators

• Indiana University: lead
• University of Notre Dame: collaborator

Study Sites (1)

Eskanazi Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Behavior

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Malaz Boustani, MD, MPH

  Indiana University School of Medicine, Center for Health Innovation and Implementation Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 21, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

US (1)