Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Conditions
Keywords
behavioral and psychological symptoms of dementia, conversational AI, avatar, informal caregiver, digital therapeutic, ABC collaborative dementia care model
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.
Interventions
DEVICEVICA - 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.
DEVICEEducation 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.
Sponsors
Indiana University
University of Notre Dame
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory (NPI) total score | 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. |
| Neuropsychiatric Inventory-Distress (NPI-D) Scale | 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. |
| Assessment completion rate | Computed at 3 months | — |
| Recruitment rate | up to 15 months | Recruitment rate computed monthly as # approached, # agreeing, and \# consenting, tracked continuously throughout the accrual period. |
| Technology Acceptance Model-Perceived Ease of Use (TAM-PEOU) | 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. |
| System Usability Scale (SUS) | 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. |
| VICA usage | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 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. |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMalaz Boustani, MD, MPH
Indiana University School of Medicine, Center for Health Innovation and Implementation Science
Outcome results
None listed