Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07461415

Coaching and Navigation by Community Health Workers (CHWs) Through Telehealth for High-risk Hypertension

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital (AKUH), Karachi, Sindh, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)
  • 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).

Treatment and study plan

CONNECT-HTN

Behavioral

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.

Standard ED management

Other

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.

Primary outcomes

  1. Rate of Major Adverse Cardiac Events (MACE)

    Time frame: 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 outcomes

  1. Blood Pressure (SBP/DBP) Over Time

    Time frame: 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.

  2. Outpatient Primary Care Follow-up

    Time frame: 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

  3. Medication Adherence (MMAS-8 Score)

    Time frame: 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.

Other outcomes

  1. Proportion of outcome measurement team visits completed

    Time frame: Once every 6 months during the 36 month follow-up period

    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

  2. Assessment of Participant Satisfaction using Telehealth Usability Questionnaire (Intervention group only)

    Time frame: 6 months; 12 months; 18 months; 24 months; 30 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Junaid A Razzak, MD PhD FACEP

CONTACT

[email protected]

+1 4437229239

Sheza Hassan, MD MSc

CONTACT

[email protected]

+1 9296213558

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

CONNECT-HTN Trial - Coaching and Navigation by CHWs Through Telehealth for High-risk Hypertension

Acronym: CONNECT-HTN

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.