Implementation of a Combination Intervention for Sustainable Blood Pressure Control — IMPACT-BP  

Hypertension Clinical Trial

Official title: Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT05492955
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Contact: Shafika Abrahams-Gessel, AB, MS, DRPH
• Phone: 6174324385
• Email: sabraham@hsph.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Completion date: April 30, 2025