Key result
This protocol describes a three-arm randomized clinical trial evaluating technology-supported, community-based interventions for blood pressure control; no results are reported.
Why the study?
Hypertension is the primary risk factor for stroke and heart disease in South Africa, but there is an implementation gap in how best to deliver care in this resource-limited region.
Does a technology-supported, community-based intervention improve blood pressure control in people with hypertension compared to standard clinic-based management?
RCT
unblinded
individually randomized
Does a technology-supported, community-based intervention improve blood pressure control in people with hypertension compared to standard clinic-based management?
This protocol describes a three-arm randomized trial evaluating technology-supported, community-based interventions for hypertension management in rural South Africa.
Protocol for RCT of tech-supported community BP interventions published; leaves open efficacy until results reported.
BACKGROUND: Hypertension is the primary risk factor for stroke and heart disease, which are leading causes of death in South Africa. Despite the availability of treatments, there is an implementation gap in how best to deliver hypertension care in this resource-limited region. METHODS: We describe a three-arm parallel group individually randomized control trial to evaluate the effectiveness and implementation of a technology-supported, community-based intervention to improve blood pressure control among people with hypertension in rural KwaZulu-Natal. The study will compare three strategies: 1) standard of care (SOC arm) clinic-based management, 2) home-based blood pressure management supported by community blood pressure monitors (CBPM arm) and a mobile health application to record blood pressure readings and enable clinic-based nurses to remotely manage care, and 3) an identical strategy to the CBPM arm, except that participants will use a cellular blood pressure cuff, which automatically transmits completed readings over cellular networks directly to clinic-based nurses (eCBPM+ arm). The primary effectiveness outcome is change in blood pressure from enrollment to 6 months. The secondary effectiveness outcome is the proportion of participants with blood pressure control at 6 months. Acceptability, fidelity, sustainability, and cost-effectiveness of the interventions will also be assessed. CONCLUSIONS: In this protocol, we report the development of interventions in partnership with the South Africa Department of Health, a description of the technology-enhanced interventions, and details of the study design so that our intervention and evaluation can inform similar efforts in rural, resource-limited settings. PROTOCOL: Version 3 November 9th, 2022. CLINICALTRIALS: gov Trial Registration: NCT05492955 SAHPRA Trial Number: N20211201. SANCTR Number: DOH-27-112,022-4895.
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Sithole et al. (2023) conducted an RCT in Hypertension. Home-based blood pressure management (CBPM and eCBPM+) vs. Standard of care clinic-based management was evaluated on Change in blood pressure from enrollment to 6 months. This protocol describes a three-arm randomized clinical trial evaluating technology-supported, community-based interventions for blood pressure control; no results are reported.
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