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
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 pati...
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doaj-f3119dd40abd4804bb0672f2fa9c14812020-11-25T02:26:53ZengBMCTrials1745-62152019-05-0120111210.1186/s13063-019-3364-xProtocol 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 TibetXiaolin Wei0Joseph Paul Hicks1Pande Pasang2Zhitong Zhang3Victoria Haldane4Xiaoqiu Liu5Tingting Yin6Lixia Wang7Dachun Shi8Shiliang Ge9John Walley10Ross Upshur11Jun Hu12Dalla Lana School of Public Health, University of TorontoNuffield Centre for International Health and Development, University of LeedsShigatse Centre for Disease Control and PreventionShigatse Centre for Disease Control and PreventionDalla Lana School of Public Health, University of TorontoChina National Centre for Tuberculosis Prevention and Control, China National Centre for Disease Control and PreventionWeifang Medical CollegeChina National Centre for Tuberculosis Prevention and Control, China National Centre for Disease Control and PreventionShigatse Centre for Disease Control and PreventionDalla Lana School of Public Health, University of TorontoNuffield Centre for International Health and Development, University of LeedsDalla Lana School of Public Health, University of TorontoShigatse Centre for Disease Control and PreventionAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3364-xTuberculosisTreatment adherenceMhealthRandomised controlled trialTibet |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 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 Tuberculosis Treatment adherence Mhealth Randomised controlled trial Tibet |
author_facet |
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 |
author_sort |
Xiaolin Wei |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-05-01 |
description |
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. |
topic |
Tuberculosis Treatment adherence Mhealth Randomised controlled trial Tibet |
url |
http://link.springer.com/article/10.1186/s13063-019-3364-x |
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