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

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841683
• Other study ID #: Cnamts_2016_1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: August 2020
• Source: Ecole des Hautes Etudes en Santé Publique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2806
• Est. completion date: September 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

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

Locations

Country	Name	City	State
France	université de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Ecole des Hautes Etudes en Santé Publique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence abstinence of 7 days		6 months
Secondary	continuous abstinence rate	Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint	6 months
Secondary	continuous abstinence rate	Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint	12 months
Secondary	minimum 24-hour point abstinence		3 months
Secondary	minimum 30-day point abstinence		12 months
Secondary	number of quit attempts		6 months
Secondary	total duration of quit attempts	calculated as sum of days with no use	6 months