RCT of HeartBot in Women (HeartBot II)

February 11, 2026 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Waitlist Control
Other: Waitlist Control
The waitlist control group will not receive the HeartBot II intervention during the initial 12-week period, but will receive a text message once week for 12 weeks for attention control. These text messages do not include any educational content related to heart attack or heart health and are limited to neutral study reminders and general self-report prompts. Following completion survey at week 12, participants in the waitlist control group will initiate the HeartBot II program, delivered identically to the intervention group.
Experimental: HeartBot Intervention
Other: HeartBot II Program
Participants assigned to the intervention group will receive the HeartBot II intervention during the first 12 weeks. Participants in the intervention group will download the HeartBot II application on their smartphone, register their account with the access code provided by the research team, and will be asked to start Module 1 immediately after randomization. The HeartBot II application consists of 4 module and each module is scheduled approximately 3 weeks apart. It will take about 13 minutes to complete each modules.
Other Names:
  • HeartBot Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awareness and knowledge of symptoms and response to a heart attack
Time Frame: 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?
Baseline, week 12, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HeartBot II evaluation
Time Frame: Baseline, week 12, week 24

We measure chatbot communication quality by looking at 1) message effectiveness using the validated Effectiveness scale consisting of five semantic differential items (e.g., effective-ineffective) on a 7-point scale, 2) impression of chatbot messages using the validated Anthropomorphism scale consisting of five bipolar adjective pairs (e.g., fake-natural) on a 7-point scale, and 3) conversational naturalness and coherence using two single-items on a 5-point scale (e.g., "Overall, how would you rate the conversations with your texting partner?" (1=Very unnatural, 5=Very natural).

Chatbot identity perception is measured by asking "Do you think you texted human or artificial intelligent chatbot during your conversation?" with response options: (1) Human and (2) AI chatbot.

To explore perceptions of AI in healthcare, participants will be asked to rate agreement with the three statements using a 5-point scale (e.g., "The use of artificial intelligence will result in better healthcare")
Baseline, week 12, week 24
Perceived risk of heart attack
Time Frame: Baseline, week 12, week 24
Participants are asked 3 items asking to compare their risk of experiencing a heart attack to other women their age over different time frames (next 5 years, next 10 years, lifetime)
Baseline, week 12, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

University of California, Davis

Investigators

  • Principal Investigator: Yoshimi Fukuoka, Ph.D., RN, FAAN, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-44825

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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