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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartBot Intervention | Experimental |
| |
| Waitlist Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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") |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoshimi Fukuoka, Ph.D., RN, FAAN | Contact | 415-476-8419 | Yoshimi.Fukuoka@ucsf.edu | |
| Diane Dagyong Kim | Contact | 415-766-8473 | dagkim@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yoshimi Fukuoka, Ph.D., RN, FAAN | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| 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. |
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| 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) | Baseline, week 12, week 24 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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