Implementation of a Combination Intervention for Sustainable Blood Pressure Control

Sponsor
Brigham and Women's Hospital
Study ID
NCT05492955
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Mar 2026
Primary completion
Dec 18, 2024
Completion
Jul 17, 2025

Study Design

Enrollment
774 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care (SOC)
    Participants will receive clinic-based standard of care
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Mean Systolic Blood Pressure (SBP) Change [ Time Frame: 6 months ]

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