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尼日利亚改善高血压控制方案的开发与评估[DEPIHCON]:一项整群随机对照试验。

Development and evaluation of a package to improve hypertension control in Nigeria [DEPIHCON]: a cluster-randomized controlled trial.

作者信息

Ajayi IkeOluwapo O, Oyewole Oyediran E, Ogah Okechukwu S, Akinyemi Joshua O, Salawu Mobolaji M, Bamgboye Eniola A, Obembe Taiwo, Olawuwo Morenikeji, Sani Mahmoud Umar

机构信息

Epidemiology and Biostatistics Research Unit, Institute of Advanced Medical Research and Training, College of Medicine, University of Ibadan, Ibadan, Nigeria.

Department of Epidemiology and Medical Statistics, Faculty of Public Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.

出版信息

Trials. 2022 May 2;23(1):366. doi: 10.1186/s13063-022-06209-9.

Abstract

BACKGROUND

Nigeria's healthcare system capacity to stem the increasing trend in hypertension is limited in coverage, scope and manpower. Use of trained community-based care providers demonstrated to be an effective complement in improving access to, and supporting healthcare delivery has not been adequately examined for hypertension care in Nigeria. This study is proposed to evaluate the effectiveness of using trained community-oriented resource persons (CORPs) to improve hypertension control in Nigeria.

METHODS

An intervention study will be conducted in three states using a mixed method design. First is a baseline survey using a semi-structured pre-tested questionnaire to collect information on demographics, clinical data, knowledge, occurrence and risk factors of hypertension among 1704 adults ≥18 years. Focus group discussions (FGD) and key informant interviews (KII) will be conducted to explore a community's experience of hypertension, challenges with hypertension management and support required to improve control in 10 selected communities in each state. The second is a cluster-randomized controlled trial to evaluate effect of a package on reduction of blood pressure (BP) and prevention of cardiovascular (CVD) risk factors among 200 hypertensive patients to be followed up in intervention and control arms over a 6-month period in each state. The package will include trained CORPs conducting community-based screening of BP and referral, diagnosis confirmation and initial treatment in the health facility, followed by monthly home-based follow-up care and provision of health education on hypertension control and healthy lifestyle enhanced by phone voice message reminders. In the control arm, the usual care (diagnosis, treatment and follow-up care in hospital of a patient's choice) will continue. Third, an endline survey will be conducted in both intervention and control communities to evaluate changes in mean BP, control, knowledge and proportion of other CVD risk factors. In addition, FGD and KII will be used to assess participants' perceived quality and acceptability of the interventions as delivered by CORPs.

DISCUSSION

This research is expected to create awareness, improve knowledge, perception, behaviours, attitude and practices that will reduce hypertension in Nigeria. Advocacy for buy-in and scale up of using CORPs in hypertension care by the government is key if found to be effective.

TRIAL REGISTRATION

PACTR Registry PACTR202107530985857 . Registered on 26 July 2021.

摘要

背景

尼日利亚医疗保健系统遏制高血压上升趋势的能力在覆盖范围、规模和人力方面都很有限。在尼日利亚,对于高血压护理而言,利用经过培训的社区护理提供者作为改善医疗服务可及性和支持医疗服务提供的有效补充这一点尚未得到充分研究。本研究旨在评估利用经过培训的社区导向型资源人员(CORPs)改善尼日利亚高血压控制情况的有效性。

方法

将在三个州开展一项采用混合方法设计的干预性研究。首先是一项基线调查,使用经过预测试的半结构化问卷收集1704名18岁及以上成年人的人口统计学信息、临床数据、高血压知识、发病率及风险因素。将在每个州的10个选定社区进行焦点小组讨论(FGD)和关键信息人访谈(KII),以探究社区对高血压的体验、高血压管理面临的挑战以及改善控制所需的支持。其次是一项整群随机对照试验,以评估一套方案对200名高血压患者降低血压(BP)和预防心血管疾病(CVD)风险因素的效果,每个州的干预组和对照组将对这些患者进行为期6个月的随访。该方案将包括由经过培训的CORPs开展基于社区的血压筛查和转诊、在医疗机构进行诊断确认和初始治疗,随后进行每月一次的居家随访护理,并通过电话语音信息提醒加强关于高血压控制和健康生活方式的健康教育。在对照组中,将继续提供常规护理(在患者选择的医院进行诊断、治疗和随访护理)。第三,将在干预社区和对照社区开展一项终末调查,以评估平均血压、控制情况、知识以及其他心血管疾病风险因素比例的变化。此外,FGD和KII将用于评估参与者对CORPs提供的干预措施的感知质量和可接受性。

讨论

本研究有望提高人们的认识,改善知识、认知、行为、态度和做法,从而降低尼日利亚的高血压发病率。如果证明有效,政府倡导支持并扩大在高血压护理中使用CORPs至关重要。

试验注册

泛非洲临床试验注册中心(PACTR)注册号PACTR**********。于2021年7月26日注册。 (注:原文注册号部分不全,翻译时保留原文格式)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8486/9059388/d7c5535d982f/13063_2022_6209_Fig1_HTML.jpg

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