[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596431":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":68,"studyPopulation":64,"armGroups":69,"interventions":80,"overallOfficials":86,"centralContacts":91,"locations":100,"responsibleParty":119,"collaborators":64,"id":121,"slug":64,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":64,"enrollmentInfo":131,"targetDuration":64,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":143,"whyStopped":64,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Duke Kunshan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Change in cardiovascular disease (CVD) risk awareness","assessed using a 10-item CVD Knowledge Questionnaire adapted from the Chinese version of the Cardiovascular Disease Attitudes and Beliefs Questionnaire (ABCD-C) and the Heart Disease Fact Questionnaire (HDFQ). Each item is scored as 1 (correct) or 0 (incorrect\u002FDon't know), yielding a total score range from 0 to 10. Higher scores indicate greater knowledge and awareness of CVD risk factors.","3 months",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Change in physical activity level","Change in self-reported physical activity level, measured using an 11-level categorical scale developed for this study and adapted from the WHO Stepwise approach. Responses range from 1 (completely inactive) to 11 (vigorous activity \\>25 miles\u002Fweek or \\>8 hours\u002Fweek). Higher scores indicate greater physical activity level.",{"measure":18,"description":19,"timeFrame":12},"Change in dietary behavior: fruit intake","Change in self-reported fruit consumption frequency, measured by the question: \"On how many days per week do you usually eat fruit?\" (0-7 days). Higher values indicate higher frequency of fruit intake.",{"measure":21,"description":22,"timeFrame":12},"Change in dietary behavior: table salt use","Change in self-reported table salt use, measured by a single item adapted from the WHO STEPS questionnaire: \"Do you usually add salt or salty condiments (e.g., soy sauce) at the table?\" Responses on a 5-point scale: 1 = Always, 5 = Never. Higher scores indicate lower frequency of adding table salt.",{"measure":24,"description":25,"timeFrame":12},"Change in medication adherence","Change in self-reported medication adherence, assessed using the Morisky Medication Adherence Scale, 4-item version (MMAS-4). Each item scored as Yes = 1, No = 0, for a total score range of 0-4. Lower scores indicate better medication adherence.",{"measure":27,"description":28,"timeFrame":12},"Implementation outcomes 1: Feasibility (intervention group only)","Measured using the Feasibility of Intervention Measure (FIM), 4 items, each scored on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Higher scores indicate greater perceived feasibility.",{"measure":30,"description":31,"timeFrame":12},"Implementation outcomes 2: Acceptability (intervention group only)","Measured using the Acceptability of Intervention Measure (AIM), 4 items, each scored on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Higher scores indicate greater acceptability.",{"measure":33,"description":34,"timeFrame":12},"Implementation outcomes 3: Fidelity (intervention group only)","Assessed using patient-reported and provider-reported delivery checks with categorical response options (e.g., explained fully, partially, not explained).",[36,40,43,46,49,52,55,58],{"measure":37,"description":38,"timeFrame":39},"Change in systolic blood pressure","Mean change in systolic blood pressure (mmHg) extracted from routine health records.","12 months",{"measure":41,"description":42,"timeFrame":39},"Change in diastolic blood pressure","Mean change in diastolic blood pressure (mmHg) extracted from routine health records.",{"measure":44,"description":45,"timeFrame":39},"Change in body mass index (BMI)","Mean change in body mass index (BMI, kg\u002Fm²) extracted from routine health records.",{"measure":47,"description":48,"timeFrame":39},"Change in fasting plasma glucose","Mean change in fasting plasma glucose level (mmol\u002FL) extracted from routine health records.",{"measure":50,"description":51,"timeFrame":39},"Change in total cholesterol","Mean change in total cholesterol level (mmol\u002FL) extracted from routine health records.",{"measure":53,"description":54,"timeFrame":39},"Change in low-density lipoprotein cholesterol (LDL-C)","Mean change in low-density lipoprotein cholesterol (LDL-C, mmol\u002FL) extracted from routine health records.",{"measure":56,"description":57,"timeFrame":39},"Change in high-density lipoprotein cholesterol (HDL-C)","Mean change in high-density lipoprotein cholesterol (HDL-C, mmol\u002FL) extracted from routine health records.",{"measure":59,"description":60,"timeFrame":39},"Change in triglycerides","Mean change in triglyceride level (mmol\u002FL) extracted from routine health records.",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":64,"timePerspective":64,"maskingInfo":66},"RANDOMIZED","PARALLEL",null,"HEALTH_SERVICES_RESEARCH",{"masking":67,"maskingDescription":64,"whoMasked":64},"NONE","This is a randomized controlled trial conducted a community health center in Kunshan, Jiangsu, China. Approximately 600 older adults (≥60 years) with hypertension will be recruited following completion of their national annual health check. Participants will be randomized 1:1 to receive either standard care or a Heart Age report with a brief scripted explanation delivered during their next follow-up consultation. The primary outcome is change in cardiovascular risk awareness at 3 months. Secondary outcomes include behavior change(measured by questionnaires); implementation outcomes (feasibility, acceptability, fidelity) will be measured in the intervention group. Clinical indicators (e.g., blood pressure, glucose) will be extracted from health records at 12 months as exploratory outcomes.",[70,74],{"label":71,"type":72,"description":73,"interventionNames":64},"Usual Care (Control Group)","NO_INTERVENTION","Participants in this arm will receive standard hypertension management as per Chinese national guidelines, including regular follow-up with primary care physicians. They will not receive a Heart Age report or structured cardiovascular risk communication.",{"label":75,"type":76,"description":77,"interventionNames":78},"Heart Age Communication (Intervention Group)","EXPERIMENTAL","Participants in this arm will receive a personalized Heart Age report based on their annual health check data (blood pressure, cholesterol, glucose, BMI, smoking). The report will be explained by the physician during the routine follow-up visit using a standardized script. The session lasts 3-5 minutes and is integrated into existing workflow.",[79],"Behavioral: Cognitive Intervention",[81],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":64},"BEHAVIORAL","Cognitive Intervention","Participants in the intervention arm will receive a personalized one-page Heart Age report based on data from their government-funded annual health check. The report is delivered by trained physicians using a standardized communication script during a routine follow-up visit. The control group receives usual chronic disease care without structured risk communication.",[75],[87],{"name":88,"affiliation":89,"role":90},"Guanzhou Wang","Duke University","PRINCIPAL_INVESTIGATOR",[92,97],{"name":93,"role":94,"phone":95,"phoneExt":64,"email":96},"Yuxuan Huang","CONTACT","86 18063279516","yh368@duke.edu",{"name":88,"role":94,"phone":98,"phoneExt":64,"email":99},"86 15601200248","gw122@duke.edu",[101],{"facility":102,"status":64,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Tinglin Community Health Center","Suzhou","Jiangsu","215316","China","CN",{"type":109,"coordinates":110},"Point",[111,112],120.59538,31.30408,{"lat":112,"lon":111},[115],{"name":116,"role":94,"phone":117,"phoneExt":64,"email":118},"Ruwei Yuan, MD","+86 021-5738277","guanzhouw@sina.com",{"type":120,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100596431",false,"NCT07045363","Embedded Community-based Heart-Age Risk Education Trial in Cinese Primary Healthcare","Effectiveness of an Embedded Community-based Heart-Age Risk Education Model (E-CHARM) in Improving Cardiovascular Risk Awareness and Health Behaviors Among Older Adults With Hypertension: a Randomized Controlled Trial","E-CHARM","Inclusion Criteria:\n\n* Adults aged ≥60 years\n* Diagnosed with hypertension\n* Completed their government-funded annual health check within the past 3 months\n* Scheduled for a routine follow-up consultation within the enrollment window -Able to provide informed consent-\n\nExclusion Criteria:\n\n* Diagnosed dementia or severe cognitive impairment\n* Terminal illness\n* Participation in another clinical intervention trial",true,"ALL","60 Years",{"count":132,"type":133},600,"ESTIMATED","INTERVENTIONAL",[136],"NA","This study evaluates the effectiveness of a brief Heart Age-based risk education intervention embedded in routine primary care for older adults with hypertension in China. The intervention uses routine health check data to generate a personalized one-page Heart Age report, delivered by physicians during regular follow-up visits. The trial tests whether this approach improves risk awareness and self-management behavior without disrupting clinical workflow.",[139],"Hypertension",[141,142],"Heart Age","Health education","NOT_YET_RECRUITING","2025-07-16",{"date":146,"type":147},"2025-07-20","ACTUAL",{"date":149,"type":133},"2025-07-19",{"date":151,"type":133},"2026-07-20",{"name":5,"class":6},1]