NCT01494246

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,064 (estimated)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Tobacco Dependence
• Cessation of Smoking

Interventions

Type	Name	Description
OTHER	electronic mail	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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-09-01
• Completion: 2014-12-01
• First posted: 2011-12-16
• Last updated: 2014-06-19

Locations

1 site across 1 country: Spain