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越南采用文化适应性故事讲述方法改善高血压控制——“我们谈论我们的高血压”:一项可行性整群随机对照试验的研究方案

Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial.

作者信息

Allison Jeroan J, Nguyen Hoa L, Ha Duc A, Chiriboga Germán, Ly Ha N, Tran Hanh T, Phan Ngoc T, Vu Nguyen C, Kim Minjin, Goldberg Robert J

机构信息

Department of Quantitative Health Sciences, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.

Institute of Population, Health and Development, 18 Alley 132, Hoa Bang Street, Cau Giay District, Hanoi, Vietnam.

出版信息

Trials. 2016 Jan 14;17:26. doi: 10.1186/s13063-015-1147-6.

Abstract

BACKGROUND

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed.

METHODS

A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the "storytelling" method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or "video stars," identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients.

DISCUSSION

This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel community-based intervention. Results from the full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam and other developing countries.

TRIAL REGISTRATION

ClinicalTrials.gov.

REGISTRATION NUMBER

https://clinicaltrials.gov/ct2/show/NCT02483780 (registration date June 22, 2015).

摘要

背景

越南正经历流行病学转变,非传染性疾病患病率不断上升。目前,越南心血管疾病(CVD)的主要危险因素要么呈上升趋势,要么处于令人担忧的水平;因此,除非实施有效的预防和控制措施,该国的心血管疾病负担将持续增加。2008年的一项全国性调查发现,越南成年人中高血压(HTN)患病率约为25%,且随年龄增长而上升。因此,迫切需要开展新颖、大规模且可持续的公共卫生教育干预措施,以促进越南高血压检测和治疗过程中的参与度。

方法

将在越南兴安省进行一项可行性随机试验,以评估一种基于社区的新颖干预措施的可行性和可接受性,该措施采用“讲故事”方法来加强对四个农村社区成年居民高血压的控制。干预措施将以高血压患者自述的生活故事为核心。这些故事将从故事发展小组中识别出的特别能言善辩的患者,即“视频明星”那里获取。该研究将包括两个阶段:(i)使用讲故事方法制定高血压干预措施,旨在使患者有能力促进其生活方式的改变;(ii)进行可行性整群随机试验,以调查该干预措施与常规护理相比在农村居民高血压控制方面的可行性、可接受性和潜在效果。试验将在四个公社进行,每个公社将招募25名50岁及以上的高血压患者参加试验,总样本量为100名患者。

讨论

这项可行性试验将为后续大规模、充分动力的整群随机对照试验提供必要的基础,以测试我们基于社区的新颖干预措施的效果。全面试验的结果将为卫生政策制定者提供实际证据,说明如何通过一种可行、可持续且具有成本效益的干预措施来应对心血管疾病的一个关键危险因素,该干预措施可作为越南和其他发展中国家控制高血压的国家项目。

试验注册

ClinicalTrials.gov。

注册号

https://clinicaltrials.gov/ct2/show/NCT02483780(注册日期:2015年6月22日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8c/4712480/0f7c8d3b3cf1/13063_2015_1147_Fig1_HTML.jpg

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