VICA: A Virtual Care Assistant for Dementia Caregivers

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 21 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Alzheimer Dementia (AD), Caregiver Burden of People With Dementia

Being tested

VICA - Virtual Informal Care Assistant, Education only BPSD mobile app

Keywords

behavioral and psychological symptoms of dementia, conversational AI, avatar, informal caregiver, digital therapeutic, ABC collaborative dementia care model

Medical subject headings

Alzheimer Disease, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• VICA - Virtual Informal Care AssistantDevice

  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 appDevice

  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 being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: Baseline, 1, 2, and 3 months

3. Assessment completion rate

   Measured: Computed at 3 months

4. Recruitment rate

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

   # consenting, tracked continuously throughout the accrual period.

   Measured: up to 15 months

5. 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.

   Measured: Months 1, 2, 3

6. 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.

   Measured: Months 1, 2, 3

7. 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.

   Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Aug 2026
2. Study start17 Aug 2026 (estimated)
3. Primary completion28 Feb 2027 (estimated)
4. Study completion30 May 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.