Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial

作者：James Lewis, Xiaoqiu Liu, Zhiying Zhang, Bruce Thomas, Anna Vassall, Sedona Sweeney, Caihong Xu, Dongmei Hu, Li Xue, Yongxin Gao, Shitong Huan, Jiang Shiwen, Katherine Fielding · 发表于：Trials · 年份：2018 · DOI：10.1186/s13063-018-2650-3 · 被引用次数：33 · 研究领域：Tuberculosis Research and Epidemiology、Pneumocystis jirovecii pneumonia detection and treatment、Mobile Health and mHealth Applications

BACKGROUND: Treatment for drug-sensitive tuberculosis (TB) is taken for at least 6 months and problems with adherence are common. Therefore, there is substantial interest in the possible use of eHealth interventions to support patients to take their treatment. Electronic medication monitors have been shown to improve adherence to TB medication, but the impact on clinical outcomes is unknown. We aim to evaluate the impact of a medication monitor-based treatment strategy for drug-sensitive TB patients on a composite poor outcome measured over 18 months from start of TB treatment. METHODS/DESIGN: We will conduct an open, pragmatic, cluster randomised superiority trial, with 24 counties/districts in three provinces in China, randomised 1:1 to implement the intervention or standard of care. Adults (aged ≥ 18 years) with a new episode of GeneXpert-positive and rifampicin-sensitive pulmonary TB, who plan to be in the study area for the next 18 months, and will receive daily fixed-dose combination tablets for 6 months of treatment are eligible. The intervention is centred around a medication monitor that holds a 1-month supply of medication and has three key functions: as an audio and visual reminder for patients to take their daily medication; reminds patients of upcoming monthly visit; and records date and time whenever the box is opened. At the monthly follow-up visit, the doctor downloads these data to generate a graphical display of the last month's adherence record for discussi...