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Life sciences · Interventional Study
ClinicalTrials.gov · October 26, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07779785). This is a study registration, not published results. Lead sponsor: Indiana University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Alzheimer Dementia (AD), Caregiver Burden of People With Dementia. Interventions: DEVICE: VICA - Virtual Informal Care Assistant; DEVICE: Education only BPSD mobile app. Primary outcome measures: Neuropsychiatric Inventory (NPI) total score , Baseline, 1, 2, and 3 months; Neuropsychiatric Inventory-Distress (NPI-D) Scale , Baseline, 1, 2, and 3 months; Assessment completion rate , Computed at 3 months; Recruitment rate , up to 15 months; Technology Acceptance Model-Perceived Ease of Use (TAM-PEOU) , Months 1, 2, 3; System Usability Scale (SUS) , Months 1, 2, 3; VICA usage , up to 12 weeks. 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).