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Completed

NCT Number: NCT05492955

Implementation of a Combination Intervention for Sustainable Blood Pressure Control

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Africa Health Research Institute (AHRI)

Mtubatuba, KwaZulu-Natal, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CHW Model

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.

Other names: eCHW+ Model

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.

Other names: SOC Model

Primary outcomes

  1. 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

  1. Percentage of Participants With Blood Pressure Control (%)

    Time frame: 6 months

    Percentage of participants in each of the three study arms who had achieved blood pressure (BP) control.

    BP control is defined the percentage of participants who have a measured BPe <140/90 mmHg, among the total number of participants, in each respective study arm, as measured at 6 months after enrollment.

    The percentages reported are model-based estimated probabilities rather than raw observed proportions, and estimated using logistic regression, adjusted for the randomisation strata and baseline antihypertensive medication use. Arm-specific probabilities were obtained using marginal standardisation, yielding predicted probabilities from the fitted model, averaged over the covariate distribution of the analysis population, rather than counts divided by the number of participants arm. Estimates are thus continuous quantities not constrained to correspond exactly to whole numbers (e.g., 0.768 × 257 ≈ 197.4 participants), which is expected and statistically appropriate.

Other outcomes

  1. Number of Participants Who Experienced Adverse Events (Safety)

    Time frame: 6 months

    Number of participants who experienced adverse and severe adverse events, in each of the three study arms.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)

Acronym: IMPACT-BP

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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