Telehealth coaching and navigation by community health workers for adults with very high blood pressure
CONNECT-HTN Trial - Coaching and Navigation by CHWs Through Telehealth for High-risk Hypertension
This trial will test whether phone-based coaching and help from community health workers can lower the risk of major heart and blood vessel problems for adults who come to the emergency department with very high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3620 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 4 sites (Karachi, Sindh and 3 other locations) |
| Trial ID | NCT07461415 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial in Karachi randomly assigns adults who present to participating emergency departments with severe hypertension to either usual referral to primary care or to structured telephone-based navigation and behavioral coaching delivered by trained community health workers. The primary outcome is the rate of major adverse cardiovascular events over follow-up, with secondary outcomes including changes in blood pressure and outpatient follow-up patterns. Outcome assessments are performed by an independent team blinded to treatment assignment. The intervention is designed to be compatible with basic phones and to be scalable for low-resource urban settings.
Who should consider this trial
Good fit: Adults (18+) who present to participating Karachi EDs with repeat systolic BP >180 mmHg or diastolic BP >110 mmHg without acute end-organ damage and who can receive phone contact are ideal candidates.
Not a fit: Pregnant patients, terminally ill patients, those requiring hospital admission for complications, and people who cannot be reached by phone are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could lower rates of heart attacks, strokes, and other major cardiac events by improving blood pressure control and outpatient follow-up.
How similar studies have performed: Previous programs using community health workers and telehealth have improved follow-up and blood pressure control in some settings, but evidence that this approach reduces major cardiovascular events in an ED-to-primary-care pathway is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Karachi, Sindh and 3 other locations
- 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)
Study contacts
- Principal investigator: Junaid Razzak, MD PhD FACEP — Weill Medical College of Cornell University
- Study coordinator: Junaid A Razzak, MD PhD FACEP
- Email: jur9123@med.cornell.edu
- Phone: +1 4437229239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.