Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial|
- Change in smoking status and maintenance in smoking cessation [ Time Frame: the outcome measure is studied at 6 and 12 months ] [ Designated as safety issue: Yes ]The term used to name long term abstinence over 6 months is continuous abstinence.
- point prevalence abstinence [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]In case ok not reaching abstinence, will be measured if a subject has changed of stage in "transtheoretical model of Prochaska and DiClemente".
- self-reported tobacco consumption [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
- self-reported smoking reduction [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]In case not reaching abstinence
- stage of change in Prochaska cycle [ Time Frame: the outcome measure will be studied at 3,6 and 12 months ] [ Designated as safety issue: Yes ]
- used time by professionals to achieve patients stop smoking [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
- used time by participants [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
- cost to get smoking help in primary care service [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]The estimated cost of helping people to leave smoking in regular conditions
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: electronic mail||
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.
Other Name: e-mail, electronic mail, computer intervention,
|No Intervention: brief advise|
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.
|Contact: Laura Díaz Gete, MDfirstname.lastname@example.org|
|Contact: Elisa Puigdomènech Puig, Byologistemail@example.com|
|Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.||Recruiting|
|Barcelona, Spain, 08007|
|Contact: Elisa Puigdomenech, Byologist 0034935675640 firstname.lastname@example.org|
|Study Chair:||José L Ballvé Moreno, MD||Institut Català de la Salut|
|Study Chair:||Marc Casajuana, Economist||Idiap Jordi Gol|
|Study Chair:||Lourdes Clemente, MD||Servicio Aragonés de Salud|
|Principal Investigator:||Laura Díaz Gete, MD||Institut Català de la Salut|
|Study Chair:||Elena M Briones Carrió, Statistician||Idiap Jordi Gol|
|Study Chair:||Mireia Fàbregas Escurriola, MD||Institut Català de la Salut|
|Study Chair:||Elisa Puigdomènech Puig, Byologist||Idiap Jordi Gol|
|Study Chair:||José L del Val, MD||Institut Català de la Salut|
|Study Chair:||Soraya Fernández Maestre, nurse||Institut Català de la Salut|
|Study Chair:||Carlos Martín Cantera, MD, Ph D||Institut Català de la Salut. Research Unit of Barcelona, IDIAP Jordi Gol. Department of Medicine, University Autonomus of Barcelona|
|Study Chair:||Ricardo Almon, MD, PhD||Family Medicine Research centre School of Health and medical Sciences. Örebro University|