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Design, development and randomised controlled trial of a smartphone application, ‘QinTB’, for smoking cessation in tuberculosis patients: study protocol
  1. Haoxiang Lin1,
  2. Yan Lin2,
  3. Yunting Zheng1,
  4. Zhao Liu3,
  5. Chun Chang1
  1. 1Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China
  2. 2International Union Against Tuberculosis and Lung Disease, Paris, France
  3. 3Tobacco Medicine and Tobacco Cessation Center, China-Japan Friendship Hospital, Beijing, China
  1. Correspondence to Dr Chun Chang; changchun{at}bjmu.edu.cn; Dr Zhao Liu; lzlzq2004{at}126.com

Abstract

Introduction Providing smoking cessation treatment is an important intervention for tuberculosis (TB) patients. Mobile technologies, such as smartphone applications, have shown promising potential. However, there are few effective applications that could support TB patients in their efforts to quit smoking. To address this problem, we will develop a smartphone application ‘QinTB’ to help TB patients quit smoking, and we will evaluate the clinical efficacy of this application by using a randomised controlled trial (RCT).

Methods and analysis This is a two-step study. In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory. Then, we will perform an RCT using a two-arm design; a total of 400 patients will be randomly assigned to the application group or the doctors’ advice group; both treatments will be 6 months and follow-up will be 12 months; the primary outcome is the biochemically verified 6 month sustained abstinence rate; data will be analysed on an intention-to-treat basis.

Ethics and dissemination This study was approved by the Ethics Committee of Beijing Research Institute for Tuberculosis Control and Prevention. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.

Trial registration number This study was registered in the Chinese Clinical Trial Registry (ChiCTR1900022008) and the stage is Pre-results.

  • smoking cessation
  • smartphone application
  • transtheoretical model (TTM)
  • protection motivation theory (PMT)
  • randomized controlled trial (RCT)

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors CC and ZL should be considered co-corresponding authors. HL and ZL drafted the manuscript; ZL and YL participated in the conception and design of the study; CC, YL and YZ made critical manuscript revisions. All authors approved the final version of the clinical trial protocol.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study was approved by the Ethics Committee of Beijing Research Institute for Tuberculosis Control and Prevention.

  • Provenance and peer review Not commissioned; externally peer reviewed.