Implementation of a Combination Intervention for Sustainable Blood Pressure Control
- Conditions
- Hypertension
- Interventions
- Behavioral: Community Health Worker Care ModelBehavioral: Standard of Care ModelBehavioral: Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model
- Registration Number
- NCT05492955
- Lead Sponsor
- Brigham and Women's Hospital
- 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 β₯ 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 774
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Community Health Worker Care Model (CHW) Community Health Worker Care Model 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. Standard of Care (SOC) Standard of Care Model Participants will receive clinic-based standard of care Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+) Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model 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 Measures
Name Time Method Mean systolic blood pressure change 6 months Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
- Secondary Outcome Measures
Name Time Method Achievement of blood pressure control 6 months Blood pressure control, defined as a BP \<140/90 6 months after enrollment
Trial Locations
- Locations (1)
Africa Health Research Institute (AHRI)
πΏπ¦Mtubatuba, KwaZulu-Natal, South Africa