Pragmatic Randomised Controlled Trial Evaluating Effectiveness of a Smoking Cessation e- Intervention  Tabac Info Service 

Study Overview
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Brief Summary
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Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs). Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results. Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.

Official Title
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Evaluation of Effectiveness of Tabac Info Service (EE-TIS)

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: Tabac Info Service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult smokers with an information and consent form completed agreed to participate in the study get a Smartphone and be willing to use applications wanting stop smoking (in short, medium or long terms). Exclusion Criteria: refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle counseling<br>A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application | Behavioral: Tabac Info Service<br>* A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application<br>|
| No Intervention: Current practices<br>Current practices of smoking cessation in France | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence abstinence of 7 days |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous abstinence rate | Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint | 6 months | 
| continuous abstinence rate | Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint | 12 months | 
| minimum 24-hour point abstinence |  | 3 months | 
| minimum 30-day point abstinence |  | 12 months | 
| number of quit attempts |  | 6 months | 
| total duration of quit attempts | calculated as sum of days with no use | 6 months |