[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628421":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":47,"studyPopulation":40,"armGroups":48,"interventions":61,"overallOfficials":71,"centralContacts":75,"locations":85,"responsibleParty":129,"collaborators":131,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":64,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":40,"enrollmentInfo":144,"targetDuration":40,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":88,"whyStopped":40,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of Major Adverse Cardiac Events (MACE)","Major Adverse Cardiovascular Events (MACE) is a composite outcome including heart attack (myocardial infarction), stroke, heart failure, and cardiovascular death. The primary outcome will be assessed by comparing the cumulative incidence of MACE events between participants randomized to the CONNECT-HTN intervention arm and those randomized to referral to clinic-based care. MACE events will be identified through participant interviews, hospital record review, death certificates during the outcome collection team visit and verbal autopsy when required, and adjudicated using standardized criteria.","Up to 36 months (during the outcome collection period)",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Blood Pressure (SBP\u002FDBP) Over Time","Change in systolic and diastolic blood pressure over time, measured during blinded home visits using standardized oscillometric assessment. At each visit, three blood pressure readings will be obtained five minutes apart and averaged. Longitudinal blood pressure trajectories will be compared between trial arms.","Every 6 months during follow-up (up to 36 months)",{"measure":19,"description":20,"timeFrame":21},"Outpatient Primary Care Follow-up","Proportion of participants who attend at least one outpatient primary care visit for hypertension management during the study period, assessed via participant report and\u002For available medical records during the outcome collection team visit","Up to 36 months",{"measure":23,"description":24,"timeFrame":25},"Medication Adherence (MMAS-8 Score)","Medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), a validated self-report questionnaire commonly used in hypertension research. Scores range from 0 to 8, with higher scores indicating greater adherence. Adherence will be measured during blinded home visits and compared between study arms over time during the outcome collection team visit.","Every 6 months during the 36-month follow-up period.",[27,31],{"measure":28,"description":29,"timeFrame":30},"Proportion of outcome measurement team visits completed","Proportion of scheduled outcome measurement team home visits successfully completed over the study period. Outcome measurement team, blinded to the study arm, will visit all patients at 6 month intervals to get their in home BP monitoring and collect information on patient's medication adherence, self-efficacy, and quality of life","Once every 6 months during the 36 month follow-up period",{"measure":32,"description":33,"timeFrame":34},"Assessment of Participant Satisfaction using Telehealth Usability Questionnaire (Intervention group only)","Participant satisfaction with the CONNECT-HTN intervention will be assessed using the Telehealth Usability Questionnaire (TUQ), a seven-point Likert-scale instrument consisting of 21 questions administered to participants randomized to the intervention arm.","6 months; 12 months; 18 months; 24 months; 30 months",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":40,"timePerspective":40,"maskingInfo":41},"RANDOMIZED","PARALLEL","Stratified and blocked randomization will be used for individuals meeting enrollment criteria. The randomization will be stratified by gender, and blocked randomization (with varying block sizes) will be used to allocate patients in a 1:1 ratio to either the T-CHW or the referral arm","HEALTH_SERVICES_RESEARCH",null,{"masking":42,"maskingDescription":43,"whoMasked":44},"DOUBLE","Randomized Controlled Trial",[45,46],"PARTICIPANT","OUTCOMES_ASSESSOR","This study is a randomized controlled trial evaluating whether telehealth-based coaching and navigation delivered by community health workers can improve cardiovascular outcomes among adults presenting to Emergency Departments (EDs) in Karachi with severe hypertension. Participants are randomly assigned either to receive a standard referral to primary care or to receive structured telephone-based navigation and behavioral coaching from trained community health workers.\n\nThe primary objective is to determine whether the CONNECT-HTN intervention reduces the rate of major adverse cardiovascular events (MACE) over the follow-up period. Secondary objectives include evaluating changes in blood pressure over time and examining patterns of follow-up in outpatient primary care. Outcome assessments are conducted by an independent team blinded to treatment assignment.\n\nThe study aims to provide evidence on the effectiveness of a scalable telehealth-supported community health worker model for improving long-term outcomes among patients with severe hypertension in low-resource urban settings.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Referral arm","ACTIVE_COMPARATOR","In the referral arm, patients with hypertension will receive a digital BP monitor (an Omron device), a brief teaching session on its proper use, and an emergency medical services number for any medical concerns. A small outcomes team will visit their household within 3 months of their discharge from the Emergency Department (ED) to review their readings and ask a few more questions about their health. This outcome team will visit every 6 months for a total of five home visits to monitor their health.",[54],"Other: Standard ED management",{"label":56,"type":57,"description":58,"interventionNames":59},"T-CHW arm","EXPERIMENTAL","In the T-CHW arm, patients with hypertension will receive a digital BP monitor (an Omron device) and a brief teaching session on its proper use. They will also be connected with a Community Healthcare Worker (CHW) via a telephone number. The CHW will call them to ask about their health and counsel them on diet and exercise to support good blood pressure control. The CHW will call them every month at a mutually convenient time for up to 36 months.\n\nA small outcomes team will visit their household within 3 months of their discharge from the ED to review their readings and ask a few more questions about their health. This outcome team will visit every 6 months for a total of five home visits to monitor their health.",[60],"Behavioral: CONNECT-HTN",[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":40},"BEHAVIORAL","CONNECT-HTN","We propose a multimodal intervention that leverages the success of CHWs and telehealth to connect patients with severe hypertension to primary care resources and coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. We call the intervention Coaching and Navigation by CHW through Telehealth for High-risk Hypertension or CONNECT-HTN. CONNECT HTN will add to the evidential basis for implementing many of the WHO Best Buys for Non-Communicable Disease (NCD) prevention and control, and will be the first study powered to measure substantive mortality and mortality outcomes in LMICs.",[56],{"type":6,"name":68,"description":69,"armGroupLabels":70,"otherNames":40},"Standard ED management","During the Emergency Department (ED) admission, the participants in the control group will be provided a blood pressure measurement device and training to calculate their blood pressure at home. Standard ED management will be provided to these patients, followed by either discharge or admission for the management of hypertension.",[50],[72],{"name":73,"affiliation":5,"role":74},"Junaid Razzak, MD PhD FACEP","PRINCIPAL_INVESTIGATOR",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":40,"email":80},"Junaid A Razzak, MD PhD FACEP","CONTACT","+1 4437229239","jur9123@med.cornell.edu",{"name":82,"role":78,"phone":83,"phoneExt":40,"email":84},"Sheza Hassan, MD MSc","+1 9296213558","shh4019@med.cornell.edu",[86,105,111,116,121],{"facility":87,"status":88,"city":89,"state":90,"zip":40,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Aga Khan University Hospital (AKUH)","RECRUITING","Karachi","Sindh","Pakistan","PK",{"type":94,"coordinates":95},"Point",[96,97],67.0104,24.8608,{"lat":97,"lon":96},[100,102,103],{"name":101,"role":78,"phone":40,"phoneExt":40,"email":40},"Badar Afzal, MBBS",{"name":101,"role":74,"phone":40,"phoneExt":40,"email":40},{"name":104,"role":74,"phone":40,"phoneExt":40,"email":40},"Unab Khan, MBBS",{"facility":106,"status":107,"city":89,"state":90,"zip":40,"country":91,"countryCode":92,"cosmosGeoPoint":108,"geoPoint":110,"contacts":40},"Dow University Hospital, Ojha Campus","WITHDRAWN",{"type":94,"coordinates":109},[96,97],{"lat":97,"lon":96},{"facility":112,"status":88,"city":89,"state":40,"zip":40,"country":91,"countryCode":92,"cosmosGeoPoint":113,"geoPoint":115,"contacts":40},"Jinnah Postgraduate Medical Center (JPMC)",{"type":94,"coordinates":114},[96,97],{"lat":97,"lon":96},{"facility":117,"status":88,"city":89,"state":40,"zip":40,"country":91,"countryCode":92,"cosmosGeoPoint":118,"geoPoint":120,"contacts":40},"Kharadar General Hospital (KGH)",{"type":94,"coordinates":119},[96,97],{"lat":97,"lon":96},{"facility":122,"status":88,"city":89,"state":40,"zip":40,"country":91,"countryCode":92,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Sindh Institute of Emergency and Health Sciences (SIEHS)",{"type":94,"coordinates":124},[96,97],{"lat":97,"lon":96},[127],{"name":128,"role":78,"phone":40,"phoneExt":40,"email":40},"Taaban Khan, MBBS",{"type":130,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[132],{"name":133,"class":134},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100628421","coaching-and-navigation-by-community-health-workers-chws-through-telehealth-for-high-risk-hypertension-100628421",false,"NCT07461415","Coaching and Navigation by Community Health Workers (CHWs) Through Telehealth for High-risk Hypertension","CONNECT-HTN Trial - Coaching and Navigation by CHWs Through Telehealth for High-risk Hypertension","Inclusion Criteria:\n\nEligible patients\n\n* Must be over the age of 18 years\n* Have an ED triage SBP ≥ 180 and\u002For DBP ≥ 110, with a repeat similar reading ≥30 minutes after triage\n* May have received treatment for elevated BP, but must have no evidence of end-organ damage (defined as dialysis dependence, acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)\n* Have a functional status of either fully active (independent in daily activities) or mildly restricted but ambulatory and able to work (washing, toileting, dressing, feeding, mobility).\n* May be admitted for deranged BP only with no complications, or may be stable for discharge per treating emergency physician\n* Include referrals from the clinic to the ED with SBP\u002FDBP values in the inclusion range\n* Can provide informed consent. Intervention is accessible to individuals of all literacy levels\n* Can receive phone calls and in-person visits. Smartphone ownership not required (intervention compatible with analog phones)\n\nExclusion Criteria:\n\nGiven that hypertension is defined and treated differently, we will exclude\n\n* pregnant patients\n* terminally ill patients, as well as\n* those requiring admission to the hospital due to severe complications (other than deranged BP).","ALL","18 Years",{"count":145,"type":146},3620,"ESTIMATED","INTERVENTIONAL",[149],"NA","The investigators propose an intervention that leverages the success of Community Healthcare Workers (CHWs) and telehealth to connect patients with severe hypertension from Emergency Department (ED) to primary care resources and to coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. The investigators have proposed this intervention as \"Coaching and Navigation by Community Health Workers (CHWs) through Telehealth for High-risk Hypertension: CONNECT-HTN intervention. The investigators hypothesize that participants receiving the CONNECT-HTN intervention will have a lower likelihood of experiencing a major cardiac event compared with those referred to clinic-based care.",[152],"Hypertension",[154,152,155,156],"Community Healthcare Workers","Telehealth","Low-middle-income country","2026-09-14",{"date":159,"type":160},"2026-09-17","ACTUAL",{"date":162,"type":160},"2026-03-16",{"date":164,"type":146},"2029-08",{"name":5,"class":6},5]