Implementation of a Combination Intervention for Sustainable Blood Pressure Control

Not Applicable

Active, not recruiting

• Conditions: Hypertension

• Registration Number: NCT05492955
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural South Africa using Community Health Workers (CHWs) in conjunction with in-home BP monitoring among adults.

Detailed Description

We will conduct a trial using CHWs in conjunction with in-home BP monitoring among 774 adults ≥ 18 years old residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW. Eligible participants will be recruited from prior community-based hypertension screening programs, CHW-led hypertension screening activities, and/or from trial clinics where they are accessing care. Consenting participants will be randomized to one of the three study arms of hypertension care (258 participants per arm): 1) clinic-based standard of care model (SOC); 2) community health worker-based blood pressure monitoring model (CHW); 3) and enhanced community health worker-based model, including mobile health blood pressure monitoring model (eCHW+). Independent of clinical care, all participants will be seen at enrollment and at 6 months for BP monitoring and data collection by study nurses for outcome assessments. The primary effectiveness outcome will be assessed in an intention-to-treat analysis and defined as the change in systolic blood pressure (SBP) 6 months after enrollment. The secondary effectiveness outcome will be the proportion of participants with controlled blood pressure, as defined by an SBP \<140 mmHg and a diastolic BP (DBP) \<90 mmHg 6 months after enrollment.

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-09
• Study Start: 2022-11-30
• Status Verified: 2024-04
• Primary Completion: 2024-12-18
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 774

Inclusion Criteria

• Age greater than 18 years old
• Residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW.
• Elevated blood pressure (blood pressure > 140/90 mmHg) on two measurements.

Exclusion Criteria

• Pregnant or breast-feeding women.
• Severe, symptomatic hypertension with a measured blood pressure > 180/110 mmHg.
• Known, advanced chronic kidney disease. GFR < 60 ml/min/1.73 m2.
• Current use of at least 3 different anti-hypertensive therapies at full dose.
• Planning to move within the next 24 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean systolic blood pressure change	6 months	Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.

Secondary Outcome Measures

Name	Time	Method
Achievement of blood pressure control	6 months	Blood pressure control, defined as a BP \<140/90 6 months after enrollment

Trial Locations

Locations (1)

Africa Health Research Institute (AHRI); 🇿🇦 Mtubatuba, KwaZulu-Natal, South Africa