Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)
Overview
- Phase
- Not Applicable
- Intervention
- Standard of Care Model
- Conditions
- Hypertension
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 774
- Locations
- 1
- Primary Endpoint
- Mean Systolic Blood Pressure (SBP) Change
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Thomas A Gaziano
Associate Professor
Brigham and Women's Hospital
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 m
- •Current use of at least 3 different anti-hypertensive therapies at full dose.
- •Planning to move within the next 24 months.
Arms & Interventions
Standard of Care (SOC)
Participants will receive clinic-based standard of care
Intervention: Standard of Care Model
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.
Intervention: Community Health Worker Care Model
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.
Intervention: Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model
Outcomes
Primary Outcomes
Mean Systolic Blood Pressure (SBP) Change
Time Frame: 6 months
Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
Secondary Outcomes
- Percentage of Participants With Blood Pressure Control (%)(6 months)