Implementation of a Combination Intervention for Sustainable Blood Pressure Control

NCT ID: NCT05492955

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 774 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2025-07-17

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC)

Participants will receive clinic-based standard of care

Group Type: ACTIVE_COMPARATOR

Standard of Care Model

Intervention Type: BEHAVIORAL

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.

Community Health Worker Care Model (CHW)

Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.

Group Type: EXPERIMENTAL

Community Health Worker Care Model

Intervention Type: BEHAVIORAL

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.

Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)

Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CHW Model; eCHW+ Model; SOC Model

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thomas A Gaziano

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas A Gaziano, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Mark J Siedner, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Africa Health Research Institute (AHRI)

Mtubatuba, KwaZulu-Natal, South Africa

Countries

South Africa

References

Siedner MJ, Magula N, Mazibuko L, Sithole N, Castle A, Nxumalo S, Manyaapelo T, Abrahams-Gessel S, Gareta D, Orne-Gliemann J, Baisley K, Bachmann M, Gaziano TA. Home-Based Care for Hypertension in Rural South Africa. N Engl J Med. 2025 Oct 2;393(13):1304-1314. doi: 10.1056/NEJMoa2509958. Epub 2025 Sep 1.

Reference Type: DERIVED

PMID: 40888742 (View on PubMed)

Other Identifiers

2021P003469

Identifier Type: -

Identifier Source: org_study_id