Protocol: Implementation evaluation of a combination intervention for sustainable blood pressure control in rural KwaZulu-Natal, South Africa (IMPACT BP): A three-arm, unblinded, parallel group individually randomized clinical trial

Sithole, Nsika, Castle, Alison, Nxumalo, Siyabonga, Mazibuko, Lusanda, Manyaapelo, Thabang, Abrahams-Gessel, Shafika, Dlamini, Siphephelo, Gareta, Dickman, Orne-Gliemann, Joanna, Baisley, Kathy, Bachmann, Max O. ORCID: https://orcid.org/0000-0003-1770-3506, Magula, Nombulelo, Gaziano, Thomas A. and Siedner, Mark J. (2023) Protocol: Implementation evaluation of a combination intervention for sustainable blood pressure control in rural KwaZulu-Natal, South Africa (IMPACT BP): A three-arm, unblinded, parallel group individually randomized clinical trial. Contemporary Clinical Trials, 131. ISSN 1551-7144

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Abstract

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.

Item Type:	Article
Additional Information:	Data availability: Data and the data dictionary defining each field will be available at https://data.ahri.org/index.php/ via the Africa Health Research Institute Data Repository. Please email RDMServiceDesk@ahri.org. Access will be granted after publication and upon approval of the proposed analyses by the IMPACT BP Scientific Steering Committee and completion of a data access agreement. Funding Information: This IMPACT-BP trial was funded by the US National Institutes of Health (R01 HL144848). MJS also reports funding from K24 HL166024 and ACC reports funding from the Fogarty International Center (D43 TW010543) and National Institute of Allergy and Infectious Diseases (T32 AI007433). This research was also funded in part, by Wellcome [Grant number Wellcome Strategic Core award: 201433/Z/16/A ]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. The funders had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.
Uncontrolled Keywords:	community healthcare workers,digital application,hypertension,south africa,pharmacology (medical) ,/dk/atira/pure/subjectarea/asjc/2700/2736
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Centres > Population Health
Related URLs:	http://www.scopus.com/inward/record.url?...
Depositing User:	LivePure Connector
Date Deposited:	14 Jun 2023 14:15
Last Modified:	19 Oct 2023 03:36
URI:	https://ueaeprints.uea.ac.uk/id/eprint/92386
DOI:	10.1016/j.cct.2023.107258

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