Virtual Care Assistant for Alzheimer's Dementia Caregivers

(VICA Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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).

Who Is on the Research Team?

MB

Malaz Boustani, MD, MPH

Principal Investigator

Indiana University School of Medicine, Center for Health Innovation and Implementation Science

Are You a Good Fit for This Trial?

This trial is for people who are informal caregivers of someone with Alzheimer's disease or related dementias. Both the caregiver and the person they care for must be willing to participate as a pair.

Inclusion Criteria

I am 65 years old or older.
Patient is community-dwelling
Informal caregiver is self-identified caregiver of a community-dwelling patient diagnosed with ADRD
See 6 more

Exclusion Criteria

Patient has life expectancy less than 6 months
Informal caregiver has clinician-reported cognitive impairment
Informal caregiver is unable to provide informed consent
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers use the VICA platform or Dementia Guide Expert app 3 times per week for approximately 20 minutes over 3 months

12 weeks
Virtual engagement 3 times per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 1, 2, and 3 months

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares an AI-powered virtual assistant app (VICA) that offers education, symptom tracking, and coaching to caregivers against a standard educational dementia app. Participants are randomly assigned to one of these two apps for three months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: VICAExperimental Treatment1 Intervention
Group II: Active Comparator: Attention ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

University of Notre Dame

Collaborator

Trials
36
Recruited
60,000+