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

March 16, 2026 updated by: Weill Medical College of Cornell University

CONNECT-HTN Trial - Coaching and Navigation by 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3620

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Recruiting
        • Dow University of Health Sciences, Ojha Campus (DUHS)
      • Karachi, Pakistan
        • Recruiting
        • Jinnah Postgraduate Medical Center (JPMC)
      • Karachi, Pakistan
        • Recruiting
        • Sindh Institute of Emergency and Health Sciences (SIEHS)
        • Contact:
          • Taaban Khan, MBBS
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Aga Khan University Hospital (AKUH)
        • Contact:
          • Badar Afzal, MBBS
        • Principal Investigator:
          • Badar Afzal, MBBS
        • Principal Investigator:
          • Unab Khan, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Referral arm
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.
Other: 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.
Experimental: T-CHW arm

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.

A 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 36 months (during the outcome collection period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 6 months during follow-up (up to 36 months)
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
Up to 36 months
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.
Every 6 months during the 36-month follow-up period.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Once every 6 months during the 36 month follow-up period
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.
6 months; 12 months; 18 months; 24 months; 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Junaid Razzak, MD PhD FACEP, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-10029420
  • R33HL172268 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual Patient Data (IPD) that underlies results will be submitted in a report format to NIH and published in well-reputed journals.

IPD Sharing Time Frame

The data will become available at the end of trial completion when the findings are submitted to National Heart, Lung, and Blood Institute (NHLBI in the form of a detailed report.

IPD Sharing Access Criteria

The data will be accessible upon request to the Principal investigator for researchers who intend to learn, adapt, or replicate from our trial findings.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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