{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T19:35:10Z","timestamp":1786563310357,"version":"build-2736575974"},"reference-count":38,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Heart disease remains a leading cause of death for women in the United States. Despite this burden, awareness that heart disease is the leading cause of death among women declined from 65% in 2009 to 44% in 2019, with the largest declines observed among Hispanic, Black, and younger women. Thus, innovative, scalable, and cost-effective educational strategies are needed to improve women\u2019s awareness of heart attack symptoms and appropriate care-seeking behaviors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aims to evaluate the short-term efficacy of the artificial intelligence (AI) HeartBot II, a chatbot-based educational intervention, in improving women\u2019s awareness and knowledge of heart attack symptoms and care-seeking behavior compared with a waitlist control group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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 app and complete the 4 modules (including information on 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 4 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We received approval from the University of California, San Francisco, Institutional Review Board (No. 25\u201044825) on January 9, 2026, and this trial was registered on ClinicalTrials.gov (NCT07416734) on February 11, 2026, prior to enrollment of the first participant. Recruitment began in April 2026. As of manuscript submission, 86 participants were enrolled. Enrollment is expected to be completed by September 2026, and all follow-up assessments are anticipated to be completed by March 2027. Data analysis is expected to begin in spring 2027, with study results anticipated for publication later in 2027.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>To the best of our knowledge, this is the first RCT to rigorously evaluate the efficacy of the AI HeartBot II intervention. If effective, AI HeartBot II could provide a scalable, accessible, and cost-effective public health communication strategy to improve women\u2019s awareness of heart attack symptoms and promote timely care-seeking behaviors in the United States.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/103597","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T19:12:51Z","timestamp":1786561971000},"page":"e103597-e103597","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2245-9264","authenticated-orcid":false,"given":"Yoshimi","family":"Fukuoka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-7174-9684","authenticated-orcid":false,"given":"Diane Dagyong","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1733-6857","authenticated-orcid":false,"given":"Jingwen","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6893-4449","authenticated-orcid":false,"given":"Thomas J","family":"Hoffmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3371-0618","authenticated-orcid":false,"given":"Kenji","family":"Sagae","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"R1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2024.04.057","article-title":"The therapeutic effectiveness of artificial intelligence-based chatbots in alleviation of depressive and anxiety symptoms in short-course treatments: a systematic review and meta-analysis","volume":"356","author":"Zhong","journal-title":"J Affect Disord"},{"issue":"1","key":"R2","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-023-00979-5","article-title":"Systematic review and meta-analysis of AI-based conversational agents for promoting mental health and well-being","volume":"6","author":"Li","journal-title":"NPJ Digit Med"},{"key":"R3","doi-asserted-by":"publisher","DOI":"10.2196\/43862","article-title":"Conversational agent interventions for mental health problems: systematic review and meta-analysis of randomized controlled trials","volume":"25","author":"He","journal-title":"J Med Internet Res"},{"issue":"1","key":"R4","doi-asserted-by":"publisher","DOI":"10.1080\/07853890.2024.2302980","article-title":"A systematic review of artificial intelligence-powered (AI-powered) chatbot intervention for managing chronic illness","volume":"56","author":"Kurniawan","journal-title":"Ann Med"},{"issue":"1","key":"R5","doi-asserted-by":"publisher","DOI":"10.1186\/s12966-021-01224-6","article-title":"A systematic review of artificial intelligence chatbots for promoting physical activity, healthy diet, and weight loss","volume":"18","author":"Oh","journal-title":"Int J Behav Nutr Phys Act"},{"key":"R6","doi-asserted-by":"publisher","DOI":"10.2196\/42238","article-title":"Conversational agents for body weight management: systematic review","volume":"25","author":"Noh","journal-title":"J Med Internet Res"},{"key":"R7","doi-asserted-by":"publisher","DOI":"10.1177\/20552076231211634","article-title":"Conversational artificial intelligence interventions to support smoking cessation: a systematic review and meta-analysis","volume":"9","author":"Bendotti","journal-title":"Digit Health"},{"key":"R8","doi-asserted-by":"publisher","DOI":"10.2196\/40789","article-title":"Artificial intelligence-based chatbots for promoting health behavioral changes: systematic review","volume":"25","author":"Aggarwal","journal-title":"J Med Internet Res"},{"issue":"5","key":"R9","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare12050534","article-title":"The effects of artificial intelligence chatbots on women\u2019s health: a systematic review and meta-analysis","volume":"12","author":"Kim","journal-title":"Healthcare (Basel)"},{"issue":"1","key":"R10","doi-asserted-by":"publisher","DOI":"10.1093\/tbm\/ibaf007","article-title":"Leveraging artificial intelligence-mediated communication for cancer prevention and control and drug addiction: a systematic review","volume":"15","author":"Kim","journal-title":"Transl Behav Med"},{"issue":"10","key":"R11","doi-asserted-by":"publisher","first-page":"e56","DOI":"10.1161\/CIR.0000000000000659","article-title":"Heart disease and stroke statistics-2019 update: a report from the American Heart Association","volume":"139","author":"Benjamin","journal-title":"Circulation"},{"issue":"8","key":"R12","doi-asserted-by":"publisher","first-page":"e153","DOI":"10.1161\/CIR.0000000000001052","article-title":"Heart disease and stroke statistics-2022 update: a report from the American Heart Association","volume":"145","author":"Tsao","journal-title":"Circulation"},{"key":"R13","unstructured":"A woman\u2019s health: every age, every stage. American Heart Association, Go Red for women. 2024. URL: https:\/\/www.goredforwomen.org\/en\/ [Accessed 07-07-2026]"},{"issue":"7","key":"R14","doi-asserted-by":"publisher","first-page":"e239","DOI":"10.1161\/CIR.0000000000000907","article-title":"Ten-year differences in women\u2019s awareness related to coronary heart disease: results of the 2019 American Heart Association national survey: a special report from the American Heart Association","volume":"143","author":"Cushman","journal-title":"Circulation"},{"issue":"11","key":"R15","doi-asserted-by":"publisher","first-page":"1254","DOI":"10.1161\/CIR.0b013e318287cf2f","article-title":"Fifteen-year trends in awareness of heart disease in women: results of a 2012 American Heart Association national survey","volume":"127","author":"Mosca","journal-title":"Circulation"},{"issue":"2","key":"R16","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1161\/CIRCOUTCOMES.109.915538","article-title":"Twelve-year follow-up of American women\u2019s awareness of cardiovascular disease risk and barriers to heart health","volume":"3","author":"Mosca","journal-title":"Circ Cardiovasc Qual Outcomes"},{"issue":"5","key":"R17","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1161\/01.CIR.0000115222.69428.C9","article-title":"Tracking women\u2019s awareness of heart disease: an American Heart Association national study","volume":"109","author":"Mosca","journal-title":"Circulation"},{"key":"R18","doi-asserted-by":"publisher","DOI":"10.2196\/80407","article-title":"AI heartbot to increase women\u2019s awareness and knowledge of heart attacks: nonrandomized, quasi-experimental study","volume":"9","author":"Fukuoka","journal-title":"JMIR Cardio"},{"key":"R19","doi-asserted-by":"publisher","DOI":"10.2196\/73184","article-title":"Human-delivered conversation versus AI chatbot conversation in increasing heart attack knowledge in women in the United States: quasi-experimental studies","volume":"27","author":"Kim","journal-title":"J Med Internet Res"},{"key":"R20","unstructured":"Lennox D . Transforming customer experiences with AI agents and the next generation customer engagement suite. Google Cloud Blog. URL: https:\/\/cloud.google.com\/blog\/products\/ai-machine-learning\/next-generation-customer-engagement-suite-ai-agents [Accessed 15-07-2026]"},{"key":"R21","unstructured":"Customer experience agent studio. Google Cloud. URL: https:\/\/cloud.google.com\/products\/conversational-agents [Accessed 07-07-2026]"},{"key":"R22","unstructured":"Gelles-Watnick R . Americans\u2019 use of mobile technology and home broadband: some aspects of the digital divide remain, even as most U.S. adults have a smartphone or subscribe to home broadband. About 4 in 10 report being online almost constantly. Pew Research Center; 2024. URL: http:\/\/www.jstor.org\/stable\/resrep63511 [Accessed 07-07-2026]"},{"key":"R23","doi-asserted-by":"crossref","unstructured":"Williams JD Kamal E Ashour M Amr H Miller J Zweig G . Fast and easy language understanding for dialog systems with microsoft language understanding intelligent service (LUIS). Presented at: Proceedings of the 16th Annual Meeting of the Special Interest Group on Discourse and Dialogue; Sep 2-4, 2015:159-161; Prague, Czech Republic. 2015.[doi: 10.18653\/v1\/W15-4622]","DOI":"10.18653\/v1\/W15-4622"},{"key":"R24","doi-asserted-by":"publisher","DOI":"10.1016\/j.future.2021.08.015","article-title":"Empathic conversational agents for real-time monitoring and co-facilitation of patient-centered healthcare","volume":"126","author":"Adikari","journal-title":"Future Generation Computer Systems"},{"key":"R25","unstructured":"Agent settings. Google Cloud. Dialogflow CX; Jun 3, 2026. URL: https:\/\/docs.cloud.google.com\/dialogflow\/cx\/docs\/concept\/agent-settings [Accessed 19-06-2026]"},{"key":"R26","unstructured":"Guardrails. Google Cloud. CX Agent Studio; Jun 18, 2026. URL: https:\/\/docs.cloud.google.com\/customer-engagement-ai\/conversational-agents\/ps\/guardrail [Accessed 19-06-2026]"},{"key":"R27","unstructured":"Data store tool settings. Google Cloud. Dialogflow CX; Jun 18, 2026. URL: https:\/\/docs.cloud.google.com\/dialogflow\/cx\/docs\/concept\/data-store\/settings [Accessed 19-06-2026]"},{"issue":"1","key":"R28","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1001\/jama.284.1.60","article-title":"Effect of a community intervention on patient delay and emergency medical service use in acute coronary heart disease: the rapid early action for coronary treatment (REACT) trial","volume":"284","author":"Luepker","journal-title":"JAMA"},{"issue":"6","key":"R29","doi-asserted-by":"publisher","first-page":"584","DOI":"10.1002\/nur.20213","article-title":"Psychometric evaluation of the acute coronary syndrome (ACS) response index","volume":"30","author":"Riegel","journal-title":"Res Nurs Health"},{"issue":"9","key":"R30","doi-asserted-by":"publisher","first-page":"1012","DOI":"10.1089\/jwh.2016.6156","article-title":"Comparing Asian American women\u2019s knowledge, self-efficacy, and perceived risk of heart attack to other racial and ethnic groups: the mPED trial","volume":"26","author":"Fukuoka","journal-title":"J Womens Health (Larchmt)"},{"key":"R31","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrtlng.2021.11.007","article-title":"Perceived heart attack likelihood in adults with a high diabetes risk","volume":"52","author":"Fukuoka","journal-title":"Heart & Lung"},{"issue":"6","key":"R32","doi-asserted-by":"publisher","first-page":"E197","DOI":"10.1097\/JCN.0000000000000866","article-title":"Perceived risk of heart attack and type 2 diabetes in hispanic adults with overweight and obesity","volume":"37","author":"Fukuoka","journal-title":"J Cardiovasc Nurs"},{"issue":"5","key":"R33","doi-asserted-by":"publisher","first-page":"633","DOI":"10.1177\/00936502221138427","article-title":"Understanding the influence discrepancy between human and artificial agent in advice interactions: the role of stereotypical perception of agency","volume":"50","author":"Liao","journal-title":"Communic Res"},{"issue":"1","key":"R34","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1111\/j.1468-2958.2008.01340.x","article-title":"Testing an integrated model of advice giving in supportive interactions","volume":"35","author":"Feng","journal-title":"Hum Commun Res"},{"issue":"1","key":"R35","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1007\/s12369-008-0001-3","article-title":"Measurement instruments for the anthropomorphism, animacy, likeability, perceived intelligence, and perceived safety of robots","volume":"1","author":"Bartneck","journal-title":"Int J of Soc Robotics"},{"issue":"8","key":"R36","doi-asserted-by":"publisher","first-page":"e347","DOI":"10.1161\/CIR.0000000000001209","article-title":"2024 heart disease and stroke statistics: a report of US and global data from the American Heart Association","volume":"149","author":"Martin","journal-title":"Circulation"},{"issue":"12","key":"R37","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-013096","article-title":"To condition or not condition? Analysing \u201cchange\u201d in longitudinal randomised controlled trials","volume":"6","author":"Coffman","journal-title":"BMJ Open"},{"issue":"5","key":"R38","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1007\/s10459-010-9222-y","article-title":"Likert scales, levels of measurement and the \u201claws\u201d of statistics","volume":"15","author":"Norman","journal-title":"Adv Health Sci Educ Theory Pract"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","deposited":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T19:12:52Z","timestamp":1786561972000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e103597"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,12]]},"references-count":38,"URL":"https:\/\/doi.org\/10.2196\/103597","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,12]]},"article-number":"v15i1e103597"}}