[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630811":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":26,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":26},{"fullName":5,"class":6},"Jiangsu Taizhou People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Intelligent Integrated Management Group","EXPERIMENTAL","Participants receive village doctor-led integrated management supported by digital technology. This includes a digital health platform for intelligent decision-making, remote specialist support, and structured multidimensional lifestyle interventions (cardiac rehabilitation, smart wearable device monitoring, and personalized health education)",[13],"Behavioral: Digital Intelligent Integrated Management",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Management Group","ACTIVE_COMPARATOR","Participants receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and COPD) and Basic Public Health Services (BPHS) provided by primary care physicians according to national specifications.",[19],"Other: Conventional Management",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Digital Intelligent Integrated Management","This multi-component intervention includes:\n\n1. A digital chronic disease management system for AF screening and intelligent decision-making.\n2. Structured multidimensional lifestyle intervention featuring monthly peer-support group cardiac rehabilitation (aerobic, resistance, and flexibility training).\n3. Smart wearable device monitoring (HUAWEI Band 6) for heart rate and step counts.\n4. Personalized health education delivered via digital articles and videos.\n5. Integrated management services providing guideline-directed medical therapy (GDMT) for heart failure and the ABC pathway for AF",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Management","Participants in the control group receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and chronic obstructive pulmonary disease) and Basic Public Health Services (BPHS) provided by primary care physicians. The 14 government-provided BPHS items primarily include quarterly follow-up visits for patients with hypertension, diabetes, and COPD, an annual free physical examination for residents aged 65 years and older, and the distribution of health education materials.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ming Chu","Chief Physician","100630811","telemedicine-based-integrated-management-of-atrial-fibrillation-and-heart-failure-in-older-patients-in-village-clinics-100630811",false,"NCT07492524","Telemedicine-based Integrated Management of Atrial Fibrillation and Heart Failure in Older Patients in Village Clinics","Telemedicine-based Integrated Management of Atrial Fibrillation and Heart Failure in Older Patients in Village Clinics: the MIRACLE-AF II Cluster Randomized Trial","Inclusion Criteria:\n\n1. Permanent residents with local household registration at the primary level in Jiangsu Province, aged 65-80 years.\n2. Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.\n3. A documented history of HF or a diagnosis of HF based on echocardiography and\u002For NT-proBNP screening, defined by the presence of typical HF symptoms and\u002For signs, together with one of the following: reduced left ventricular ejection fraction (HFrEF; LVEF \\\u003C 40%), mildly reduced left ventricular ejection fraction (HFmrEF; LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease changes (HFpEF; LVEF ≥ 50%, meeting at least one of the following criteria: LAV 40 ml\u002Fm², E\u002Fe' ≥ 15, or TRV \\> 2.8 m\u002Fs).\n4. Management by a village clinic near the participant's place of residence.\n5. Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1. Expected life expectancy of less than 3 months.\n2. Severe renal insufficiency (Ccr \\\u003C 30ml\u002Fmin) or ongoing dialysis treatment.\n3. Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.\n4. Indications for pacemaker implantation without having undergone implantation.\n5. Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.\n6. Special populations, including patients with mental illnesses.","ALL","65 Years","80 Years",{"count":46,"type":47},1227,"ESTIMATED","INTERVENTIONAL",[50],"NA","The goal of this cluster-randomized clinical trial is to evaluate a telemedicine-based, village doctor-led integrated management program for older adults (aged 65-80 years) who have both atrial fibrillation (AF) and heart failure (HF) in rural clinics in China. It aims to answer whether the digitally-supported program improves heart failure prognosis, assessed by the MAGGIC score, at 12 months , and reduces the risk of composite endpoint events, such as cardiovascular death, stroke, or heart failure hospitalization, over 36 months compared to conventional routine care. In this study, village clinics will be randomly assigned to either the intervention group or the control group. Participants in the control group will receive conventional routine care and basic public health services , while participants in the intervention group will receive a comprehensive management program led by village doctors. This intervention includes optimized medication treatment guided by a digital health platform with remote expert support , as well as a structured multidimensional lifestyle intervention featuring peer-support group exercises, smart wearable device monitoring, and personalized health education.",[53,54],"Atrial Fibrillation","Heart Failure","NOT_YET_RECRUITING","2026-03-19",{"date":58,"type":59},"2026-03-25","ACTUAL",{"date":58,"type":47},{"date":62,"type":47},"2029-04-01",{"name":5,"class":6}]