Dataset Information

Design, development and randomised controlled trial of a smartphone application, 'QinTB', for smoking cessation in tuberculosis patients: study protocol.

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.

SUBMITTER: Lin H

PROVIDER: S-EPMC7003393 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Design, development and randomised controlled trial of a smartphone application, 'QinTB', for smoking cessation in tuberculosis patients: study protocol.

Lin Haoxiang H Lin Yan Y Zheng Yunting Y Liu Zhao Z Chang Chun C

BMJ open 20191202 12

<h4>Introduction</h4>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 r ...[more]

PMID: 31796480

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Project description:IntroductionA number of smartphone apps have been proved to be effective in assisting smoking cessation in many countries, but little is known about the effectiveness of smartphone apps that assist in smoking cessation in China. This study aims to evaluate the efficacy of cognitive behavioural therapy (CBT)-based cigarette smoking cessation smartphone app for treatment-seeking smokers in China.Methods and analysisIn this remote control, randomised controlled trial, the participants will be randomised and allocated in 1:1 ratio to smoking cessation app intervention group or to control group. Participants will receive a 12-week intervention (treatment group will receive CBT-based cigarette smoking cessation smartphone app intervention and control group will receive text messaging-based control intervention) with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include 7-hour point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 1200 smokers with willingness to make a quit attempt within a month from January 2021 to August 2021 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in August 2022. The trial results will be available by the end of 2022. All analyses will be done on an intention-to-treat basis. Based on the previous studies, we hypothesised that this CBT-based app will be an effective, feasible and accessible smoking cessation app in China.Ethics and disseminationEthical approval was obtained from the ethics committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (number: 20200129-33). Study results will be disseminated via research conference presentations and peer-reviewed publications.Trial registration numberNCT04421170.

Project description:IntroductionDepression is the leading cause of life years lost due to disability. Appropriate prevention has the potential to reduce the incidence of new cases of depression, however, traditional prevention approaches face significant scalability issues. Prevention programmes delivered by via smartphone applications provide a potential solution. The workplace is an ideal setting to roll out this form of intervention, particularly among industries that are unlikely to access traditional health initiatives and whose workplace characteristics create accessibility and portability issues. The study aims to evaluate the effectiveness of a smartphone application designed to prevent depression and improve well-being. The effectiveness of the app as a universal, selective and indicated prevention tool will also be evaluated.Methods and analysisA multicentre randomised controlled trial, to determine the effectiveness of the intervention compared with an active mood monitoring control in reducing depressive symptoms (primary outcome) and the prevalence of depression at 3 months, with secondary outcomes assessing well-being and work performance. Employees from a range of industries will be invited to participate. Participants with likely current depression at baseline will be excluded. Following baseline assessment, participants, blinded to their allocation, will be randomised to receive one of two versions of the application: headgear (a 30-day mental health intervention) or a control application (mood monitoring for 30 days). Both versions of the app contain a risk calculator to provide a measure of future risk. Analyses will be conducted within an intention-to-treat framework using mixed modelling, with additional analyses conducted to compare the moderating effect of baseline risk level and depression symptom severity on the intervention's effectiveness.Ethics and disseminationThe current trial has received ethics approval from the University of New South Wales Human Research Ethics Committee (HC17021). Study results will be disseminated through peer-reviewed journals and conferences.Trial registration numberACTRN12617000548336; Results.

Dataset Information

Design, development and randomised controlled trial of a smartphone application, 'QinTB', for smoking cessation in tuberculosis patients: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Design, development and randomised controlled trial of a smartphone application, 'QinTB', for smoking cessation in tuberculosis patients: study protocol.

Similar Datasets

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