This trial is active, not recruiting.

Conditions tobacco dependence, cessation of smoking
Treatment electronic mail
Phase phase 4
Sponsor Jordi Gol i Gurina Foundation
Collaborator Preventive Services and Health Promotion Research Network
Start date December 2012
End date September 2013
Trial size 1064 participants
Trial identifier NCT01494246, PI11/00817


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
electronic mail e-mail, electronic mail, computer intervention,
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.
(No Intervention)

Primary Outcomes

Change in smoking status and maintenance in smoking cessation
time frame: the outcome measure is studied at 6 and 12 months

Secondary Outcomes

point prevalence abstinence
time frame: the outcome measure is studied at 3, 6 and 12 months
self-reported tobacco consumption
time frame: the outcome measure is studied at 3, 6 and 12 months
self-reported smoking reduction
time frame: the outcome measure will be studied at 3, 6 and 12 months
stage of change in Prochaska cycle
time frame: the outcome measure will be studied at 3,6 and 12 months
used time by professionals to achieve patients stop smoking
time frame: the outcome measure will be studied at 3, 6 and 12 months
used time by participants
time frame: the outcome measure will be studied at 3, 6 and 12 months
cost to get smoking help in primary care service
time frame: the outcome measure will be studied at 3, 6 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial
Principal investigator Laura Díaz Gete, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.