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

Trials

Shiliang Ge¹  Xiaolin Wei¹  Ross Upshur¹  Victoria Haldane¹  Tingting Yin²  John Walley³  Joseph Paul Hicks³  Lixia Wang⁴  Xiaoqiu Liu⁴  Jun Hu⁵  Zhitong Zhang⁵  Dachun Shi⁵  Pande Pasang⁵ 

[1] 0000 0001 2157 2938, grid.17063.33, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada;0000 0004 1790 6079, grid.268079.2, Weifang Medical College, Weifang, Shandong, China;0000 0004 1936 8403, grid.9909.9, Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK;China National Centre for Tuberculosis Prevention and Control, China National Centre for Disease Control and Prevention, Beijing, China;Shigatse Centre for Disease Control and Prevention, 7 Keji Road, Samzhubze District, Shigatse, Tibet, China;

关键词: Tuberculosis;    Treatment adherence;    Mhealth;    Randomised controlled trial;    Tibet;   

DOI  :  10.1186/s13063-019-3364-x

来源: publisher

【 摘 要 】

BackgroundTreatment 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.MethodsWe 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.DiscussionOur 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 registrationCurrent Controlled Trials, ID: ISRCTN52132803. Registered on 9 November 2018.

【 授权许可】

CC BY