Implementation of a Combination Intervention for Sustainable Blood Pressure Control

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.

Conditions

• Hypertension

Interventions

BEHAVIORAL

Community Health Worker Care Model

Participants will be given a digital BP Cuff and a standardized training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week and record them in a logbook. CHWs will return to participant homes every 2-4 weeks to collect BP measurements and enter them into a data collection system, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. BP readings will be brought by the CHW to their assigned nursing supervisors at their local clinic, who will initiate and tailor medications based on a standardized clinical decision support algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors. Participants will either obtain medication(s) at the pharmacy or, as possible, have them delivered by a CHW.

BEHAVIORAL

Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model

Participants in this arm will also be given a BP Cuff, (but with cellular network capability, such that BP data can be directly transmitted to trial server), given training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week, which will be automatically uploaded onto the server to be made available by the nurse supervisors. CHWs will return to participant homes every 2-4 weeks to ensure functionality of the devices and transmission, collect BP measurements if the system is not functional, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. Nursing supervisors at the clinic will use the remotely collected BP data to initiate and tailor medications based on the same standardized clinical decision support (CDS) algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors.

BEHAVIORAL

Standard of Care Model

Participants in the SOC arm will be referred to their clinic for active care as per standard clinical protocols. All care will be provided at the clinic. Routine care consists of regular visits to the clinic until BP is under control (\<140/90 mmHg) and then at 6 monthly intervals. BP measurements to guide management decisions will be made at the clinic using standard clinic equipment. Symptoms related to hypertension and/or medications will be assessed at each visit. Medications available will include medications on the South African Essential Drug list and which are available in the pharmacy. Prescriptions are picked up at the clinic pharmacy by patients as per routine protocol at the clinics. CHWs may also conduct monitoring as guided by clinical guidelines and as advised by their clinical supervisors during the study period to assess for adherence and provide education.

Sponsors & Collaborators

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Thomas A Gaziano, MD, MSc · Massachusetts General Hospital

• Mark J Siedner, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-30

Primary Completion

2024-12-18

Completion

2025-07-17

Countries

• South Africa

Study Locations