Hypertension
Conditions
Keywords
Community Healthcare Workers, Hypertension, Telehealth, Low-middle-income country
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCONNECT-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.
OTHERStandard 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.
Sponsors
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Randomized Controlled Trial
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients * Must be over the age of 18 years * Have an ED triage SBP ≥ 180 and/or DBP ≥ 110, with a repeat similar reading ≥30 minutes after triage * 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) * 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). * May be admitted for deranged BP only with no complications, or may be stable for discharge per treating emergency physician * Include referrals from the clinic to the ED with SBP/DBP values in the inclusion range * Can provide informed consent. Intervention is accessible to individuals of all literacy levels * Can receive phone calls and in-person visits. Smartphone ownership not required (intervention compatible with analog phones)
Exclusion criteria
Given that hypertension is defined and treated differently, we will exclude * pregnant patients * terminally ill patients, as well as * those requiring admission to the hospital due to severe complications (other than deranged BP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Cardiac Events (MACE) | Up to 36 months (during the outcome collection period) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure (SBP/DBP) Over Time | Every 6 months during follow-up (up to 36 months) | 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. |
| Outpatient Primary Care Follow-up | Up to 36 months | 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 |
| Medication Adherence (MMAS-8 Score) | Every 6 months during the 36-month follow-up period. | 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. |
Countries
Pakistan
Contacts
CONTACTJunaid A Razzak, MD PhD FACEP
CONTACTSheza Hassan, MD MSc
PRINCIPAL_INVESTIGATORJunaid Razzak, MD PhD FACEP
Weill Medical College of Cornell University
Outcome results
None listed