Participants Must be Women Aged 25 Years or OlderHeartBot IINCT07416734
RCT of HeartBot in Women
A study testing HeartBot II Program in people with Participants Must be Women Aged 25 Years or Older and Participants Should Have no Self-reported History of Heart Disease or Stroke, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- HeartBot II Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Yoshimi Fukuoka, Ph.D., RN, FAAN, 415-476-8419, Yoshimi.Fukuoka@ucsf.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- 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
- Being tested
- HeartBot II Program, Waitlist Control
- Keywords
- Artificial Intelligence, Intelligent systems, Chatbot, Natural language processing, Large language models, Machine learning, Heart disease, Mobile applications, Women, Randomized controlled trial
- Medical subject headings
- Stroke, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartBot II ProgramOther
Also called HeartBot 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.
Waitlist ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HeartBot Intervention | Experimental | Not described Receives: Other: HeartBot II Program |
| Waitlist Control | Active comparator | Not described Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Baseline, week 12, week 24
Secondary outcomes (2)
HeartBot II evaluation
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")
Measured: Baseline, week 12, week 24
Perceived risk of heart attack
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)
Measured: Baseline, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Participants Must be Women Aged 25 Years or OlderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Yoshimi Fukuoka, Ph.D., RN, FAAN, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416734
- Sponsor's protocol ID
- 25-44825
- Acronym
- HeartBot II
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Aug 12;15:e103597. doi: 10.2196/103597.
PubMed 42585572
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07416734
- Acronym / sponsor ID
- HeartBot II / 25-44825
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartBot Intervention | Experimental | Other: HeartBot II Program |
| Waitlist Control | Active comparator | Other: Waitlist Control |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartBot II ProgramAlso: HeartBot ProgramParticipants 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 | HeartBot Intervention |
| Waitlist ControlThe 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. | Other | Waitlist Control |
Primary outcome
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?
2 secondary outcomes
HeartBot II evaluation
Time frame: Baseline, week 12, week 24
Perceived risk of heart attack
Time frame: Baseline, week 12, week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 42585572Fukuoka 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 Aug 12;15:e103597. doi: 10.2196/103597.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoshimi Fukuoka, Ph.D., RN, FAAN principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartBot II Program in people with Participants Must be Women Aged 25 Years or Older and Participants Should Have no Self-reported History of Heart Disease or Stroke, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoshimi Fukuoka, Ph.D., RN, FAAN (415-476-8419, Yoshimi.Fukuoka@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness and knowledge of symptoms and response to a heart attack (time frame: Baseline, week 12, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07416734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.