Implementation of a Combination Intervention for Sustainable Blood Pressure Control

NCT05492955 | Completed Results

• 1 other identifier: 2021P003469
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Systolic Blood Pressure (SBP) Change

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

  6 months

Secondary Outcomes (1)

• Percentage of Participants With Blood Pressure Control (%)

  6 months

Other Outcomes (1)

• Number of Participants Who Experienced Adverse Events (Safety)

  6 months

Study Arms (3)

Standard of Care (SOC)

ACTIVE COMPARATOR

Participants will receive clinic-based standard of care

Behavioral: Standard of Care Model

Community Health Worker Care Model (CHW)

EXPERIMENTAL

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.

Behavioral: Community Health Worker Care Model

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

EXPERIMENTAL

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.

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

Interventions

Community Health Worker Care Model 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.

Also known as: CHW Model

Community Health Worker Care Model (CHW)

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

Also known as: eCHW+ Model

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

Standard of Care Model 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.

Also known as: SOC Model

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Africa Health Research Institute (AHRI)

Mtubatuba, KwaZulu-Natal, South Africa

Location

Related Publications (1)

• 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.

  PMID: 40888742 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Shafika Abrahams-Gessel
• Organization: Brigham and Women's Hospital

sabraham@hsph.harvard.edu

617-432-4385

Study Officials

• Thomas A Gaziano, MD, MSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Mark J Siedner, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: November 30, 2022
• Primary Completion: December 18, 2024
• Study Completion: July 17, 2025
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After completion of study, data cleaning, and prespecified analyses.
• Access Criteria: Because of the sensitive nature of the data collected for this study, requests to access the data set from qualified researchers trained in human subject confidentiality protocols may be sent to the primary investigator.

Locations

ZA (1)