Telehealth coaching and navigation by community health workers for adults with very high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (defined as dialysis dependence, acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)
* Have a functional status of either fully active (independent in daily activities) or mildly restricted but ambulatory and able to work (washing, toileting, dressing, feeding, mobility).
* 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 it's running

• Aga Khan University Hospital (AKUH)
  Karachi, Sindh, Pakistan Recruiting
• Jinnah Postgraduate Medical Center (JPMC)
  Karachi, Pakistan Recruiting
• Kharadar General Hospital (KGH)
  Karachi, Pakistan Recruiting
• Sindh Institute of Emergency and Health Sciences (SIEHS)
  Karachi, Pakistan Recruiting
• Dow University Hospital, Ojha Campus
  Karachi, Sindh, Pakistan Withdrawn

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.