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

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Tabac Info Service

• Study Type: Interventional
• Enrollment (Actual): 2806
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Université de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ecole des Hautes Etudes en Santé Publique

Publications and helpful links

General Publications

• Affret A, Luc A, Baumann C, Bergman P, Le Faou AL, Pasquereau A, Arwidson P, Alla F, Cambon L. Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. BMJ Open. 2020 Oct 27;10(10):e039515. doi: 10.1136/bmjopen-2020-039515.
• Cambon L, Bergman P, Le Faou A, Vincent I, Le Maitre B, Pasquereau A, Arwidson P, Thomas D, Alla F. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial. BMJ Open. 2017 Feb 24;7(2):e013604. doi: 10.1136/bmjopen-2016-013604.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Cnamts_2016_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No