Health TrialsbyHealthPanel

VICA: A Virtual Care Assistant for Dementia Caregivers

ConditionsAlzheimer Dementia (AD)Caregiver Burden of People With Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorIndiana University

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years

Community-dwelling

Diagnosed with ADRD

Clinical notes indicate behavioral and psychological symptoms of dementia (BPSD) Inclusion Criteria: Informal Caregiver

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental: VICAExperimental treatment 1 intervention
Group B: Active Comparator: Attention ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Assessment completion rate

Time frame
Computed at 3 months
4

Recruitment rate

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

Time frame
up to 15 months

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

University of Notre Dame

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: