Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial
Abstract 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...
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2018-07-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-018-2650-3 |
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doaj-bcc458427bfb48c7a59e90340bf03e29 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
James J. Lewis Xiaoqiu Liu Zhiying Zhang Bruce V. Thomas Anna Vassall Sedona Sweeney Xu Caihong Hu Dongmei Li Xue Gao Yongxin Shitong Huan Jiang Shiwen Katherine L. Fielding |
spellingShingle |
James J. Lewis Xiaoqiu Liu Zhiying Zhang Bruce V. Thomas Anna Vassall Sedona Sweeney Xu Caihong Hu Dongmei Li Xue Gao Yongxin Shitong Huan Jiang Shiwen Katherine L. Fielding Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial Trials Tuberculosis medication monitor eHealth China trial cluster randomised |
author_facet |
James J. Lewis Xiaoqiu Liu Zhiying Zhang Bruce V. Thomas Anna Vassall Sedona Sweeney Xu Caihong Hu Dongmei Li Xue Gao Yongxin Shitong Huan Jiang Shiwen Katherine L. Fielding |
author_sort |
James J. Lewis |
title |
Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial |
title_short |
Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial |
title_full |
Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial |
title_fullStr |
Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial |
title_full_unstemmed |
Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial |
title_sort |
evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in china: study protocol for a cluster randomised controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-07-01 |
description |
Abstract 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 discussion with the patient and potentially to switch the patient to more intensive management. The primary outcome is a composite poor outcome measured over 18 months from start of TB treatment, defined as either of poor outcome at the end of treatment (death, treatment failure, or loss to follow-up) or subsequent recurrence (culture positive for TB at 12 or 18 months or re-starting TB treatment in the follow-up period). An economic evaluation will also be conducted as part of this study. Discussion This trial will assess whether a medication monitor-based treatment strategy can improve clinical outcomes for TB patients. Several trials of other eHealth interventions for TB treatment are ongoing and are summarised in this paper. This trial will provide an important part of the emerging evidence base for the potential of eHealth to improve TB treatment outcomes. Trial registration This trial was registered with Current Controlled Trials (identifier: ISRCTN35812455). Registered on May 19, 2016. |
topic |
Tuberculosis medication monitor eHealth China trial cluster randomised |
url |
http://link.springer.com/article/10.1186/s13063-018-2650-3 |
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doaj-bcc458427bfb48c7a59e90340bf03e292020-11-25T01:30:16ZengBMCTrials1745-62152018-07-0119111210.1186/s13063-018-2650-3Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trialJames J. Lewis0Xiaoqiu Liu1Zhiying Zhang2Bruce V. Thomas3Anna Vassall4Sedona Sweeney5Xu Caihong6Hu Dongmei7Li Xue8Gao Yongxin9Shitong Huan10Jiang Shiwen11Katherine L. Fielding12MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical MedicineNational Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and PreventionPATHThe Arcady GroupTB Centre, London School of Hygiene and Tropical MedicineTB Centre, London School of Hygiene and Tropical MedicineNational Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and PreventionNational Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and PreventionNational Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and PreventionNational Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and PreventionBill & Melinda Gates Foundation, China OfficeNational Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and PreventionMRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical MedicineAbstract 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 discussion with the patient and potentially to switch the patient to more intensive management. The primary outcome is a composite poor outcome measured over 18 months from start of TB treatment, defined as either of poor outcome at the end of treatment (death, treatment failure, or loss to follow-up) or subsequent recurrence (culture positive for TB at 12 or 18 months or re-starting TB treatment in the follow-up period). An economic evaluation will also be conducted as part of this study. Discussion This trial will assess whether a medication monitor-based treatment strategy can improve clinical outcomes for TB patients. Several trials of other eHealth interventions for TB treatment are ongoing and are summarised in this paper. This trial will provide an important part of the emerging evidence base for the potential of eHealth to improve TB treatment outcomes. Trial registration This trial was registered with Current Controlled Trials (identifier: ISRCTN35812455). Registered on May 19, 2016.http://link.springer.com/article/10.1186/s13063-018-2650-3Tuberculosismedication monitoreHealthChinatrialcluster randomised |