RCT of HeartBot in Women

NCT07416734 | Not Yet Recruiting

• 1 other identifier: 25-44825
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Participants Should Possess a Smartphone With an Active Data Plan or Access to Wi-Fi; Participants Must be Women Aged 25 Years or Older; Participants Should Have no Self-reported History of Heart Disease or Stroke; Participants Should Have no Terminal Illness or Diagnosed Cognitive Impairment, Including Alzheimer's Disease; Participants Should Not be a Healthcare Professionals or Healthcare Trainees; Participants Should Not be Employed in the Healthcare Field; Participants Should Reside in the United States and be a University of California, San Francisco Health Patient

Keywords

Artificial Intelligence; Intelligent systems; Chatbot; Natural language processing; Large language models; Machine learning; Heart disease; Mobile applications; Women; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Awareness and knowledge of symptoms and response to a heart attack

  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 Outcomes (2)

• HeartBot II evaluation

  Baseline, week 12, week 24

• Perceived risk of heart attack

  Baseline, week 12, week 24

Study Arms (2)

HeartBot Intervention

EXPERIMENTAL

Other: HeartBot II Program

Waitlist Control

ACTIVE COMPARATOR

Other: Waitlist Control

Interventions

HeartBot II Program OTHER

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.

Also known as: HeartBot Program

HeartBot Intervention

Waitlist Control OTHER

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.

Waitlist Control

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Stroke; Heart Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yoshimi Fukuoka, Ph.D., RN, FAAN

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshimi Fukuoka, Ph.D., RN, FAAN

CONTACT

415-476-8419; Yoshimi.Fukuoka@ucsf.edu

Diane Dagyong Kim

CONTACT

415-766-8473; dagkim@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)