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

NCT02841683 | Completed

• 1 other identifier: Cnamts_2016_1
• Study Type: interventional
• Target: 2,806
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Point prevalence abstinence of 7 days

  6 months

Secondary Outcomes (6)

• continuous abstinence rate

  6 months

• continuous abstinence rate

  12 months

• minimum 24-hour point abstinence

  3 months

• minimum 30-day point abstinence

  12 months

• number of quit attempts

  6 months

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application

Behavioral: Tabac Info Service

Current practices

NO INTERVENTION

Current practices of smoking cessation in France

Interventions

Tabac Info Service BEHAVIORAL

A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• refusal to participate in the study

Sponsors & Collaborators

• Ecole des Hautes Etudes en Santé Publique: lead

Study Sites (1)

université de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (2)

• 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.

  PMID: 33109670 DERIVED

• 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.

  PMID: 28237958 DERIVED

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: September 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

FR (1)