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.
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. The 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. The 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
3,620
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.
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.
Aga Khan University Hospital (AKUH)
Karachi, Sindh, Pakistan
RECRUITINGDow University Hospital, Ojha Campus
Karachi, Sindh, Pakistan
WITHDRAWNJinnah Postgraduate Medical Center (JPMC)
Karachi, Pakistan
RECRUITINGKharadar General Hospital (KGH)
Karachi, Pakistan
RECRUITINGSindh Institute of Emergency and Health Sciences (SIEHS)
Karachi, Pakistan
RECRUITINGRate 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.
Time frame: Up to 36 months (during the outcome collection period)
Blood Pressure (SBP/DBP) 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.
Time frame: Every 6 months during follow-up (up to 36 months)
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/or available medical records during the outcome collection team visit
Time frame: Up to 36 months
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.
Time frame: Every 6 months during the 36-month follow-up period.
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