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用于控制结核病的手环及自我导向观察疗法:一项整群随机对照试验的研究方案

Bracelet- and self-directed observational therapy for control of tuberculosis: study protocol for a cluster randomized controlled trial.

作者信息

Huang Ruixue, Ren Guofeng, Hu Jianan

机构信息

Department of Occupational and Environmental Health, Xiangya School of Public Health, Central South University, Changsha, Hunan Province, 410078, China.

Department of Nutrition and Food Hygiene, Xiangya School of Public Health, Central South University, Changsha, Hunan Province, 410078, China.

出版信息

Trials. 2017 Jul 4;18(1):286. doi: 10.1186/s13063-017-1996-2.


DOI:10.1186/s13063-017-1996-2
PMID:28673323
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5496390/
Abstract

BACKGROUND: Approximately 80% of global tuberculosis (TB) cases occur in low-resource settings, with little opportunity for TB control. We hypothesized that the rapid increase in smartphone users and advances in digital technology would render bracelet-based applications possible; specifically, that bracelet- and self-directed observational therapy (BSDOT) can be used by patients with TB to ensure adherence to TB medication regimens and by basic village physicians to monitor care. This will ultimately allow TB to be controlled in low-resource environments. METHODS AND DESIGN: This study will have three phases: development of a bracelet capable of storing pills and recording adherence to medication regimens; creation of a BSDOT smartphone application capable of supporting reminders to patients and health care interactions between patients and village physicians; and performance of a cluster randomized controlled trial in Hunan Province, China. Patients in the intervention group will receive free bracelets and smartphones, and their daily medication intake will be directed by the smartphones; the control group will receive no intervention. The primary outcome will be the TB treatment result as defined by the World Health Organization (WHO) as follows: Cured, Treatment completed, Treatment failed, Died, Lost to follow-up, Not evaluated, or Treatment success. The secondary outcome will be treatment adherence, defined as the percentage of patients receiving TB treatment who missed fewer than 5% of doses. We will also assess self-reported adherence using the Morisky, Green, and Levine Adherence Scale (MGLS) and evaluate respondents' knowledge about TB and quality of life. A regression model will be used to explore whether the interventions improve drug adherence and other outcome measures. DISCUSSION: This will be a powerful means by which to strengthen TB control and prevent TB, especially multidrug-resistant epidemics of the disease. In addition, our novel smartphone-based tool can be readily adopted for use in low-resource remote environments with limited health care facilities and few economic assets. ETHICS AND DISSEMINATION: The protocol has been approved by the Ethics Committee of Xiangya School of Public Health, Central South University (reference number: XYGW-2016-14). TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16008424 . Registered on 5 June 2016.

摘要

背景:全球约80%的结核病病例发生在资源匮乏地区,结核病控制机会很少。我们推测,智能手机用户的迅速增加和数字技术的进步将使基于手环的应用成为可能;具体而言,结核病患者可使用手环和自我指导观察疗法(BSDOT)来确保坚持结核病药物治疗方案,基层乡村医生可利用其来监测治疗情况。这最终将使结核病在资源匮乏环境中得到控制。 方法与设计:本研究将分三个阶段进行:开发一种能够储存药丸并记录药物治疗方案依从性的手环;创建一个BSDOT智能手机应用程序,该程序能够支持向患者发送提醒以及患者与乡村医生之间的医疗互动;在中国湖南省进行一项整群随机对照试验。干预组患者将免费获得手环和智能手机,其每日药物摄入量将由智能手机指导;对照组不接受干预。主要结局将是世界卫生组织(WHO)定义的结核病治疗结果,如下:治愈、治疗完成、治疗失败、死亡、失访、未评估或治疗成功。次要结局将是治疗依从性,定义为接受结核病治疗且漏服剂量少于5%的患者百分比。我们还将使用Morisky、Green和Levine依从性量表(MGLS)评估自我报告的依从性,并评估受访者对结核病的知识和生活质量。将使用回归模型来探讨干预措施是否能提高药物依从性和其他结局指标。 讨论:这将是加强结核病控制和预防结核病,尤其是预防该疾病的耐多药流行的有力手段。此外,我们基于智能手机的新型工具可很容易地应用于医疗设施有限且经济资源稀缺的资源匮乏偏远环境。 伦理与传播:该方案已获得中南大学湘雅公共卫生学院伦理委员会批准(参考编号:XYGW-2016-14)。 试验注册:中国临床试验注册中心,注册号:ChiCTR-IOR-16008424。于2016年6月5日注册。

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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e43c/5496390/477686c23231/13063_2017_1996_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e43c/5496390/589520b2fa70/13063_2017_1996_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e43c/5496390/1cf014f6316e/13063_2017_1996_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e43c/5496390/1b9590e50ccf/13063_2017_1996_Fig4_HTML.jpg

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[6]
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