Implementation of a Combination Intervention for Sustainable Blood Pressure Control (IMPACT-BP)

Mass General Brigham

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model; Behavioral: Community Health Worker Care Model; Behavioral: Standard of Care Model

Study type: Interventional

Funder types: Other

Identifiers

NCT05492955

2021P003469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 774 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

774 participants in 3 patient groups

Standard of Care (SOC)

Active Comparator group

Description:

Participants will receive clinic-based standard of care

Treatment:

Behavioral: Standard of Care Model

Community Health Worker Care Model (CHW)

Experimental group

Description:

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.

Treatment:

Behavioral: Community Health Worker Care Model

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

Experimental group

Description:

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.

Treatment:

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