Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

Abstract

IntroductionA French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy.Methods and analysesThe study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques.Ethics and disseminationThe study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles.Trial registration numberNCT02841683; Pre-results.

Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial

“…This type of intervention may thus have more favourable results within a trial than in a real-life situation. 13 It is to limit this major bias that we wanted the inclusion procedure to be the lightest possible in order to recruit smokers who were not selected because of their high motivation to participate in a trial. The major disadvantage of this methodological choice is the high attrition rate we observed.…”

“…The protocol was previously registered (NCT02841683) and published. 13 Participants were randomly assigned (1:1) to either the intervention arm (invitation to use the e-TIS app) or the control arm (current practices for smoking cessation described on a non-interactive website from the French National Mandatory Health Insurance (ameli.fr)). The current practices were based on the guidelines of the Haute Autorité de Santé.…”

“…To further characterise tobacco consumption, the present study also collected data associated with the dependency and determinants of abstinence, described elsewhere. 13 …”

“…Some subgroup analyses were conducted as defined in the study protocol. 13 Other subgroup analyses were added to the initial protocol (before the blinding was lifted): tobacco status at inclusion and plans to have or adopt a child in the following year. Sensitivity analyses were performed using only data from participants with a smoking status at 6 months, without data recovery based on 3-month and/or 12-month smoking status.…”

“…8–12 The e-TIS app provides tailored activities, self-report exercises, tips, social and/or psychological support, reassurance and motivational text messages that are adapted to the individual characteristics of the user. 13 The present study evaluated the effectiveness of the theory-based smoking cessation e-TIS app in a pragmatic randomised controlled trial conducted in France on a population-wide level.…”