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Published in: Trials 1/2019

Open Access 01-12-2019 | Tuberculosis | Study protocol

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

Authors: Xiaolin Wei, Joseph Paul Hicks, Pande Pasang, Zhitong Zhang, Victoria Haldane, Xiaoqiu Liu, Tingting Yin, Lixia Wang, Dachun Shi, Shiliang Ge, John Walley, Ross Upshur, Jun Hu

Published in: Trials | Issue 1/2019

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Abstract

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.
Appendix
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Metadata
Title
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
Authors
Xiaolin Wei
Joseph Paul Hicks
Pande Pasang
Zhitong Zhang
Victoria Haldane
Xiaoqiu Liu
Tingting Yin
Lixia Wang
Dachun Shi
Shiliang Ge
John Walley
Ross Upshur
Jun Hu
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3364-x

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