VICA: A Virtual Care Assistant for Dementia Caregivers (VICA)
2026年8月18日 更新者：MALAZ BOUSTANI、Indiana University
Virtual Informal Care Assistant for Alzheimer'S-related Dementia (VICA): A Pilot Randomized Controlled 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).
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Indiana
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Indianapolis、Indiana、美国、46202
- Eskanazi Health
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
Exclusion Criteria: Informal Caregiver
- Clinician-reported cognitive impairment
- Clinician-reported severe mental illness or substance use disorder
- Clinician-reported life expectancy of less than 6 months
- Unable to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Experimental: VICA
Access to the VICA AI-powered avatar platform for 3 months; caregivers encouraged to engage 3x/week for ~20 minutes per session.
VICA delivers education, resource information, and symptom-monitoring (HABC-Monitor) grounded in the ABC collaborative dementia care model via a retrieval-augmented generation (RAG) system.
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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.
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有源比较器：Active Comparator: Attention Control
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Neuropsychiatric Inventory (NPI) total score
大体时间：Baseline, 1, 2, and 3 months
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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.
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Baseline, 1, 2, and 3 months
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Neuropsychiatric Inventory-Distress (NPI-D) Scale
大体时间：Baseline, 1, 2, and 3 months
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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.
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Baseline, 1, 2, and 3 months
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Assessment completion rate
大体时间：Computed at 3 months
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Computed at 3 months
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Recruitment rate
大体时间：up to 15 months
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Recruitment rate computed monthly as # approached, # agreeing, and # consenting, tracked continuously throughout the accrual period. |
up to 15 months
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Technology Acceptance Model-Perceived Ease of Use (TAM-PEOU)
大体时间：Months 1, 2, 3
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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.
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Months 1, 2, 3
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System Usability Scale (SUS)
大体时间：Months 1, 2, 3
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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.
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Months 1, 2, 3
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VICA usage
大体时间：up to 12 weeks
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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.
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up to 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
大体时间：Baseline, 1, 2, and 3 months
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A 9-item caregiver-reported measure of depressive symptom severity.
Scored 0-27; higher scores indicate more severe depression.
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Baseline, 1, 2, and 3 months
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Generalized Anxiety Disorder 7-item Scale (GAD-7)
大体时间：Baseline, 1, 2, and 3 months
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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.
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Baseline, 1, 2, and 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Malaz Boustani, MD, MPH、Indiana University School of Medicine, Center for Health Innovation and Implementation Science
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月17日
初级完成 (估计的)
2027年2月28日
研究完成 (估计的)
2027年5月30日
研究注册日期
首次提交
2026年8月12日
首先提交符合 QC 标准的
2026年8月18日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.