protocolSection identificationModule nctId: NCT06324981, orgStudyIdInfo id: 22-2097, secondaryIdInfos id: 1UG3HL168504, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3HL168504, briefTitle: Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking.This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes.The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes.The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center.The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease., conditionsModule conditions: Cardiovascular Diseases, conditions: Lifestyle Factors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 2100, type: ESTIMATED, armsInterventionsModule interventions name: Generic text messages, interventions name: Interactive AI chatbot text messaging, interventions name: Proactive pharmacist support, outcomesModule primaryOutcomes measure: Change in Life's Essential 8 risk score, secondaryOutcomes measure: Blood pressure (Individual Life's Essential 8 components), secondaryOutcomes measure: Total cholesterol (Individual Life's Essential 8 components), secondaryOutcomes measure: Blood sugar (Individual Life's Essential 8 components), secondaryOutcomes measure: Body Mass Index (Individual Life's Essential 8 components), secondaryOutcomes measure: Physical activity (Individual Life's Essential 8 components), secondaryOutcomes measure: Sleep (Individual Life's Essential 8 components), secondaryOutcomes measure: Smoking habits (Individual Life's Essential 8 components), secondaryOutcomes measure: Health diet pattern (Individual Life's Essential 8 components), secondaryOutcomes measure: Self-Efficacy for Managing Chronic Diseases, secondaryOutcomes measure: Number of medication refill gaps (Medication adherence), secondaryOutcomes measure: Length of refill gaps (Medication adherence), secondaryOutcomes measure: Clinic events, secondaryOutcomes measure: Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score, secondaryOutcomes measure: Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score, secondaryOutcomes measure: Rate of routine clinical visits and/or other procedures associated with the clinical condition, secondaryOutcomes measure: Cost, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Denver Health, status: RECRUITING, city: Denver, state: Colorado, zip: 80204, country: United States, contacts name: Pamela Peterson, MD MPH, role: CONTACT, email: pamela.peterson@dhha.org, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Salud Family Health Centers, status: NOT_YET_RECRUITING, city: Fort Lupton, state: Colorado, zip: 80621, country: United States, contacts name: Emily Kosirog, PharmD, role: CONTACT, email: ekosirog@saludclinic.org, geoPoint lat: 40.08471, lon: -104.81303, locations facility: STRIDE Community Health Centers, status: NOT_YET_RECRUITING, city: Wheat Ridge, state: Colorado, zip: 80033, country: United States, contacts name: Danielle Montoya, PharmD, role: CONTACT, email: danielle.montoya@stridechc.org, geoPoint lat: 39.7661, lon: -105.07721, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-11, uploadDate: 2023-12-04T16:49, filename: Prot_000.pdf, size: 325640, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-02-26, uploadDate: 2024-03-04T15:41, filename: SAP_001.pdf, size: 235057, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-07, uploadDate: 2024-03-04T16:34, filename: ICF_002.pdf, size: 788437, hasResults: False