Clinical trial NCT05492955: Implementation of a Combination Intervention for Sustainable Blood Pressure Control
Official title: Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 m2.
* Current use of at least 3 different anti-hypertensive therapies at full dose.
* Planning to move within the next 24 months.

Primary outcomes:
measure: Mean systolic blood pressure change
timeFrame: 6 months
Secondary outcomes:
measure: Achievement of blood pressure control
timeFrame: 6 months
Other outcomes:
measure: Adverse events (safety)
timeFrame: 6 months
Locations:
city: Mtubatuba
country: South Africa
facility: Africa Health Research Institute (AHRI)
state: KwaZulu-Natal
Study officials:
affiliation: Mass General Brigham
name: Thomas A Gaziano, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass General Brigham
name: Mark J Seidner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: