VICA: A Virtual Care Assistant for Dementia Caregivers (VICA)

August 18, 2026 updated by: MALAZ BOUSTANI, Indiana University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Eskanazi Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1, 2, and 3 months
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.
Baseline, 1, 2, and 3 months
Assessment completion rate
Time Frame: Computed at 3 months
Computed at 3 months
Recruitment rate
Time Frame: up to 15 months

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)
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.
Months 1, 2, 3
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.
Months 1, 2, 3
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.
up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1, 2, and 3 months
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.
Baseline, 1, 2, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Notre Dame

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Malaz Boustani, MD, MPH, Indiana University School of Medicine, Center for Health Innovation and Implementation Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB28255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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