Efficacy of the Artificial Intelligence HeartBot II in Increasing Awareness and Knowledge of Heart Attack in Women: Study Protocol for a Randomized Controlled Trial With a Waitlist Control
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Awareness and knowledge of symptoms and response to a heart attack
研究概览
简要总结
The goal of this clinical trial is to find out whether an app-based program called HeartBot II, which uses an artificial intelligence (AI) chatbot, can help improve women's awareness and knowledge of heart attacks in women.
This is an online study with about 200 women taking part. Participants will be randomly assigned (by chance) to one of two groups: an intervention group or a wait-list control group.
Participants in the intervention group will begin using the HeartBot II program right away. Participants in the wait-list control group will wait 12 weeks before starting the HeartBot II program. The HeartBot II program includes four short modules. In each module, participants will interact with a chatbot and spend about 10 to 15 minutes completing the content.
Participants will be asked to complete an online screening and baseline survey at the start of the study, as well as two follow-up surveys at 12 weeks and 24 weeks.
详细描述
We conducted a series of studies to evaluate the feasibility, acceptability, and potential efficacy of an AI chatbot (HeartBot I) in increasing women's awareness and knowledge of heart attack symptoms and appropriate care-seeking behavior. The results of those studies and HeartBot I design details were published elsewhere. In brief, HeartBot I was feasible (i.e., no withdrawal from HeartBot I conversation) and accepted by women, and its interactions were significantly associated with improvements in awareness and knowledge of all heart attack outcomes. However, since HeartBot I was a rule-based chatbot, its behavior and responses were limited to content authored specifically for HeartBot I conversations. To improve HeartBot I's capacity, we incorporated all women's heart attack and relevant questions collected in our previous studies and expanded its knowledge bank to enable more educational conversations. To achieve more human-like natural and personalized conversations, we implemented a new version of HeartBot (HeartBot II) powered by an LLM, specifically gemini-2.5-flash through the Google Conversational Agents platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •25 years or older
- •Living in the US
- •University of California, San Francisco Health patient
- •Possessing a smartphone with a data plan or Wi-Fi access
排除标准
- •Individuals who identify as male
- •Having self-reported cognitive impairment
- •Having history of heart disease or stroke
- •Healthcare professional/trainee
- •Working in the healthcare field
研究组 & 干预措施
HeartBot Intervention
干预措施: HeartBot II Program (Other)
Waitlist Control
干预措施: Waitlist Control (Other)
结局指标
主要结局
Awareness and knowledge of symptoms and response to a heart attack
时间窗: Baseline, week 12, week 24
Participants will answer the following four questions assessing participants' awareness and knowledge of symptoms and response to a heart attack on a 4-point scale, ranging from 1, in which 1 indicates "not sure", to 4, which indicates "sure": (1) How sure are you that you could recognize the signs and symptoms of a heart attack in yourself, (2) How sure are you that you could tell the difference between the signs or symptoms of a heart attack and other medical problems?, (3) How sure are you that you could call an ambulance or dial 911 if you thought you were having a heart attack?, (4) How sure are you that you could get to an emergency room within 60 minutes after onset of your symptoms?
次要结局
- HeartBot II evaluation(Baseline, week 12, week 24)
- Perceived risk of heart attack(Baseline, week 12, week 24)