Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption

Study Overview
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Brief Summary
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Objectives. To evaluate the effectiveness and cost effectiveness of clinical practice guide based intervention with two face-to-face visits and e-mail tracking compared to brief advice to obtain continued smoking abstinence at 6 and 12 months after intervention. Methodology. simple randomized controlled multicentric trial. All smokers (N=1064) aged 18 or older that attend by any reason to the primary care center and that have an e-mail account and they checked it at least once a week will be invited to participate. The enrolled participants will be randomly divided into control (N=532) and intervention group (N=532). An intensive intervention, based on the recommendations of the clinical practice guides, that will include six contacts (2 face-to-face and 4 by e-mail) will be applied to the intervention group. Control group will receive brief advice. The main dependent variable will be continued abstinence of tobacco consumption at six and twelve months after the beginning of the intervention which will be validated by and a carbon monoxide breathe analysis measured by a cooximeter in standard conditions. Secondary variables will include: stage change on the quitting smoking process and evaluation of the effectiveness on the reduction of the number of smoked cigarettes at six and twelve months after intervention. A descriptive analysis of all variables will be done. A multivariate analysis will be undertaken to assess differences among intervention and control group; logistic regression for dichotomic variables and lineal regression for continuous variables.

Detailed Description
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In preliminary phase is planned to carry out 2 descriptive sub-studies: a qualitative one, which will reflect the views of patients and physicians regarding the use of email as a smoking cessation intervention, and another smoker's profile in relation to Information and Communication Technologies (ICT), which collects information on the actual use of them in smokers. The result of both will help to release data on the type of participants who would be involved in the clinical trial.

Official Title
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Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial

Conditions
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Tobacco Dependence, Cessation of Smoking

Intervention / Treatment
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* Other: electronic mail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokers over 18 years old with an e-mail account who use frequently. (Smoker is an individual who smokes any amount of tobacco, whatever this amount it is. E-mail regular user is the one who uses it as a way of communication at least once per week) Exclusion Criteria: Not regular e-mail users, patients who have diseases that advise not to stop smoking: Terminal diseases Serious psychiatric disorders Active addiction to other psychoactive drugs Patients in smoking cessation process whatever the cause that does not allow to understand goals and methodology of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electronic mail<br> | Other: electronic mail<br>* Some e-mail will be sent to participants who will be in the intervention group in order to intensify the brief advise received for stop smoking.<br>* Other names: e-mail, electronic mail, computer intervention,;|
| No Intervention: brief advise<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in smoking status and maintenance in smoking cessation | The term used to name long term abstinence over 6 months is continuous abstinence. | the outcome measure is studied at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| point prevalence abstinence | In case ok not reaching abstinence, will be measured if a subject has changed of stage in transtheoretical model of Prochaska and DiClemente. | the outcome measure is studied at 3, 6 and 12 months | 
| self-reported tobacco consumption |  | the outcome measure is studied at 3, 6 and 12 months | 
| self-reported smoking reduction | In case not reaching abstinence | the outcome measure will be studied at 3, 6 and 12 months | 
| stage of change in Prochaska cycle |  | the outcome measure will be studied at 3,6 and 12 months | 
| used time by professionals to achieve patients stop smoking |  | the outcome measure will be studied at 3, 6 and 12 months | 
| used time by participants |  | the outcome measure will be studied at 3, 6 and 12 months | 
| cost to get smoking help in primary care service | The estimated cost of helping people to leave smoking in regular conditions | the outcome measure will be studied at 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, computer-assisted instruction, electronic mail, program evaluation, smoking cessation/methods, continued abstinence