An interventional study of VICA - Virtual Informal Care Assistant and Education only BPSD mobile app in Alzheimer Dementia (AD) and Caregiver Burden of People With Dementia, sponsored by Indiana University. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
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).
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patient
Exclusion Criteria: Patient
Exclusion Criteria: Informal Caregiver
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline, 1, 2, and 3 months
Assessment completion rate
Time frame: Computed at 3 months
Recruitment rate
Recruitment rate computed monthly as # approached, # agreeing, and \# consenting, tracked continuously throughout the accrual period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
A 9-item caregiver-reported measure of depressive symptom severity. Scored 0-27; higher scores indicate more severe depression.
Time frame: Baseline, 1, 2, and 3 months
Generalized Anxiety Disorder 7-item Scale (GAD-7)
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.
Time frame: Baseline, 1, 2, and 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 7 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: start Aug 2026 → Nov 2026, primary completion Feb 2027 → Jun 2027 and completion May 2027 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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