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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841683
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Linda Cambon, Ecole des Hautes Etudes en Santé Publique

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.


Condition or disease Intervention/treatment Phase
Tobacco Smoking Behavioral: Tabac Info Service Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2806 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Effectiveness of Tabac Info Service (EE-TIS)
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Point prevalence abstinence of 7 days [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. continuous abstinence rate [ Time Frame: 6 months ]
    Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint

  2. continuous abstinence rate [ Time Frame: 12 months ]
    Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint

  3. minimum 24-hour point abstinence [ Time Frame: 3 months ]
  4. minimum 30-day point abstinence [ Time Frame: 12 months ]
  5. number of quit attempts [ Time Frame: 6 months ]
  6. total duration of quit attempts [ Time Frame: 6 months ]
    calculated as sum of days with no use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841683


Locations
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France
université de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
Ecole des Hautes Etudes en Santé Publique
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Linda Cambon, Professor, Ecole des Hautes Etudes en Santé Publique
ClinicalTrials.gov Identifier: NCT02841683    
Other Study ID Numbers: Cnamts_2016_1
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No