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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jun 4, 2026
Date Accepted: Jun 26, 2026

The final, peer-reviewed published version of this preprint can be found here:

Short-Term Efficacy of the Artificial Intelligence HeartBot II in Increasing Awareness and Knowledge of Heart Attack in Women: Protocol for a Randomized Controlled Trial With a Waitlist Control

Fukuoka Y, Kim DD, Zhang J, Hoffmann TJ, Sagae K

Short-Term Efficacy of the Artificial Intelligence HeartBot II in Increasing Awareness and Knowledge of Heart Attack in Women: Protocol for a Randomized Controlled Trial With a Waitlist Control

JMIR Res Protoc 2026;15:e103597

DOI: 10.2196/103597

PMID: 42585572

Short-term 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

  • Yoshimi Fukuoka; 
  • Diane Dagyong Kim; 
  • Jingwen Zhang; 
  • Thomas J Hoffmann; 
  • Kenji Sagae

ABSTRACT

Background:

Heart disease remains a leading cause of death for women in the United States. However, awareness and knowledge are declining. Artificial intelligence (AI) chatbots have great potential to educate women. This study aims to evaluate the efficacy of the AI HeartBot II in increasing women’s awareness and knowledge of heart attack symptoms and care-seeking behavior, as compared to a waitlist control group.

Methods:

This randomized controlled clinical trial (RCT) with a waitlist control will enroll 200 women aged 25 or older, who will be randomized using a 1:1 allocation ratio. The intervention group will download the AI HeartBot II application and complete the four HeartBot II modules (e.g., heart attack symptoms, risk factors, and calling 911) over 12 weeks. The waitlist control group will start receiving an identical intervention at 12 weeks. The primary outcomes will be change from baseline to 12 weeks in a 4-item heart attack response preparedness score, calculated as the mean of four self-reported items assessing confidence in recognizing signs and symptoms of a heart attack, distinguishing heart attack symptoms from other medical problems, calling 911 or an ambulance if a heart attack is suspected, and reaching an emergency room within 60 minutes of symptom onset. The primary analysis will estimate the intervention effect using constrained longitudinal data analysis implemented with linear mixed models, including fixed effects for time and time-by-treatment group interaction. Sensitivity analyses for the individual ordinal items will use ordinal logistic mixed-effects models. Discussion: To the best of our knowledge, this is the first RCT to rigorously evaluate the efficacy of the AI HeartBot II intervention. If demonstrated to be effective, the chatbot has the potential to provide a scalable and cost-effective public health communication strategy to improve awareness and knowledge of heart attack symptoms among women in the United States.


 Citation

Please cite as:

Fukuoka Y, Kim DD, Zhang J, Hoffmann TJ, Sagae K

Short-Term Efficacy of the Artificial Intelligence HeartBot II in Increasing Awareness and Knowledge of Heart Attack in Women: Protocol for a Randomized Controlled Trial With a Waitlist Control

JMIR Res Protoc 2026;15:e103597

DOI: 10.2196/103597

PMID: 42585572

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