西藏通过电子监测器和应用程序改善肺结核患者治疗依从性的随机对照试验方案：与常规护理相比。
Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients' treatment adherence via electronic monitors and an app versus usual care in Tibet.
机构信息
Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.
出版信息
Trials. 2019 May 16;20(1):273. doi: 10.1186/s13063-019-3364-x.
BACKGROUND
Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet.
METHODS
We will use a multicentre, parallel-group, individually randomised controlled, superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥ 15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to the World Health Organisation standard 6-month TB treatment regimen and the China National TB programme guidelines. Intervention arm patients will be given their medication via e-monitors that have automatic voice reminders, and record medication adherence data and share it with health staff via Cloud connection. Intervention patients will also be encouraged to receive smartphone-based video-observed treatment if their adherence is problematic. Control arm patients will receive their medication in e-monitors that will collect medication adherence history, but will have their reminder function deactivated and are not linked to the app. The primary outcome is the rate of poor adherence, measured monthly during treatment as a binary indicator where poor adherence means missing ≥ 20% of doses in a month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and an analysis of the long-term effects of the intervention on TB control.
DISCUSSION
Our study is one of the first trials to evaluate the use of e-monitors and smartphone apps for customised treatment support in low- and middle-income countries (LMICs). All intervention activities are designed to be embedded into routine TB care with strong local ownership. Through the trial we intend to understand the feasibility of our intervention, its effectiveness, its cost-effectiveness and its long-term impacts to inform future scale-up in remote areas of China and other LMICs.
TRIAL REGISTRATION
Current Controlled Trials, ID: ISRCTN52132803 . Registered on 9 November 2018.
背景
治疗不依从是有效控制西藏结核病（TB）的一个严重挑战。在这项研究中，我们将试点并评估使用新型电子监测仪（e 监测仪）和智能手机应用程序来提高西藏新肺结核患者治疗依从性的效果。
方法
我们将采用多中心、平行组、个体随机对照、优效性试验，采用盲法结局评估和非盲治疗。我们将在诊断时，按照 1:1 的比例，将来自西藏日喀则的新肺结核门诊患者（年龄≥15 岁且无交流障碍）随机分配到干预组或对照组。所有患者将按照世界卫生组织标准的 6 个月结核病治疗方案和中国国家结核病规划指南进行治疗。干预组患者将通过具有自动语音提醒的电子监测仪给药，并通过云连接记录药物依从性数据并与卫生工作人员共享。如果干预患者的依从性有问题，也将鼓励他们接受基于智能手机的视频观察治疗。对照组患者将在电子监测仪中服药，该监测仪将收集药物依从性历史，但将停用其提醒功能，并且不与应用程序连接。主要结局是治疗期间每月测量的不良依从率，作为缺失一个月中≥20%剂量的二进制指标。我们将进行定性过程评估，以探索可接受性、文化适宜性和技术使用负担方面的操作性问题，以及成本效益分析和对干预措施对结核病控制的长期影响分析。
讨论
我们的研究是评估在中低收入国家（LMICs）使用电子监测仪和智能手机应用程序进行定制化治疗支持的首批试验之一。所有干预活动都旨在嵌入到常规结核病护理中，并具有强烈的地方所有权。通过这项试验，我们旨在了解我们的干预措施的可行性、有效性、成本效益及其对中国偏远地区和其他 LMICs 未来扩大规模的长期影响，以提供信息。
试验注册
当前对照试验，ID：ISRCTN52132803。于 2018 年 11 月 9 日注册。
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