方案：南非夸祖鲁-纳塔尔省农村地区可持续血压控制联合干预措施实施效果评估（IMPACT BP）：一项三臂、非盲、平行组个体随机临床试验。

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.

机构信息

Africa Health Research Institute, KwaZulu-Natal, South Africa.

Africa Health Research Institute, KwaZulu-Natal, South Africa; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.

出版信息

Contemp Clin Trials. 2023 Aug;131:107258. doi: 10.1016/j.cct.2023.107258. Epub 2023 Jun 10.

DOI:10.1016/j.cct.2023.107258

PMID:37308076

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10527603/

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.

PROTOCOL

Version 3 November 9th, 2022.

CLINICALTRIALS

gov Trial Registration: NCT05492955 SAHPRA Trial Number: N20211201. SANCTR Number: DOH-27-112,022-4895.

摘要

背景

高血压是中风和心脏病的主要风险因素，这两种疾病在南非是主要的死亡原因。尽管有治疗方法，但在资源有限的地区，如何最好地提供高血压护理方面存在实施差距。

方法

我们描述了一项三臂平行组个体随机对照试验，以评估一种技术支持的、基于社区的干预措施在改善夸祖鲁-纳塔尔省农村地区高血压患者血压控制方面的有效性和实施情况。该研究将比较三种策略：1）标准护理（SOC 臂）诊所管理，2）基于家庭的血压管理，由社区血压监测器（CBPM 臂）和移动健康应用程序支持，用于记录血压读数并使诊所护士能够远程管理护理，以及 3）与 CBPM 臂相同的策略，但参与者将使用蜂窝血压袖带，该袖带可通过蜂窝网络自动传输已完成的读数直接传输到诊所护士（eCBPM+臂）。主要有效性结果是从入组到 6 个月时血压的变化。次要有效性结果是 6 个月时血压控制的参与者比例。还将评估干预措施的可接受性、保真度、可持续性和成本效益。