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NCT Number: NCT07779785

VICA: A Virtual Care Assistant for Dementia Caregivers

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).

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Key information

Conditions

Alzheimer Dementia (AD) Alzheimer Disease Behavior Brain Diseases Caregiver Burden of People With Dementia Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskanazi Health

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Neuropsychiatric Inventory (NPI) total score

    Time frame: Baseline, 1, 2, and 3 months

    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.

  2. Neuropsychiatric Inventory-Distress (NPI-D) Scale

    Time frame: Baseline, 1, 2, and 3 months

    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.

  3. Assessment completion rate

    Time frame: Computed at 3 months

  4. Recruitment rate

    Time frame: up to 15 months

    Recruitment rate computed monthly as # approached, # agreeing, and

    # consenting, tracked continuously throughout the accrual period.

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

    Time frame: Months 1, 2, 3

    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.

  6. System Usability Scale (SUS)

    Time frame: Months 1, 2, 3

    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.

  7. VICA usage

    Time frame: up to 12 weeks

    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.

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, 1, 2, and 3 months

    A 9-item caregiver-reported measure of depressive symptom severity. Scored 0-27; higher scores indicate more severe depression.

  2. Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Time frame: Baseline, 1, 2, and 3 months

    A 7-item caregiver self-report measure of anxiety symptom severity, scored 0-3 per item and summed for a total ranging 0-21; higher scores indicate more severe anxiety.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • University of Notre Dame

Registry information

Official study title

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

Acronym: VICA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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