NCT07461415

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,620 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-16
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2026-03-10
• Last updated: 2026-03-18

Locations

4 sites across 1 country: Pakistan