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

NCT07461415 | Recruiting DMC

• 2 other identifiers: 25-10029420R33HL172268
• Study Type: interventional
• Target: 3,620
• Locations: 1 country
• Sites: 4

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.

Conditions

Hypertension

Keywords

Community Healthcare Workers; Hypertension; Telehealth; Low-middle-income country

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Blood Pressure (SBP/DBP) Over Time

  Every 6 months during follow-up (up to 36 months)

• Outpatient Primary Care Follow-up

  Up to 36 months

• Medication Adherence (MMAS-8 Score)

  Every 6 months during the 36-month follow-up period.

Other Outcomes (2)

• Proportion of outcome measurement team visits completed

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

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

  6 months; 12 months; 18 months; 24 months; 30 months

Study Arms (2)

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.

Other: Standard ED management

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. 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

Interventions

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.

T-CHW arm

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.

Referral arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Aga Khan University Hospital (AKUH)

Karachi, Sindh, 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)

Karachi, Pakistan

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Junaid Razzak, MD PhD FACEP

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junaid A Razzak, MD PhD FACEP

CONTACT

+1 4437229239; jur9123@med.cornell.edu

Sheza Hassan, MD MSc

CONTACT

+1 9296213558; shh4019@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomized Controlled Trial
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 10, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

PA (4)