Clinical trial NCT01494246: Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption
Official title: Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tobacco Dependence
Cessation of Smoking
Keywords: Adult
computer-assisted instruction
electronic mail
program evaluation
smoking cessation/methods
continued abstinence
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Public Health Service of Cataluña
name: Carlos III Health Institute
First posted: 2011-12-16
Enrollment: 1064
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in smoking status and maintenance in smoking cessation
timeFrame: the outcome measure is studied at 6 and 12 months
Secondary outcomes:
measure: point prevalence abstinence
timeFrame: the outcome measure is studied at 3, 6 and 12 months
measure: self-reported tobacco consumption
timeFrame: the outcome measure is studied at 3, 6 and 12 months
measure: self-reported smoking reduction
timeFrame: the outcome measure will be studied at 3, 6 and 12 months
measure: stage of change in Prochaska cycle
timeFrame: the outcome measure will be studied at 3,6 and 12 months
measure: used time by professionals to achieve patients stop smoking
timeFrame: the outcome measure will be studied at 3, 6 and 12 months
measure: used time by participants
timeFrame: the outcome measure will be studied at 3, 6 and 12 months
measure: cost to get smoking help in primary care service
timeFrame: the outcome measure will be studied at 3, 6 and 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.
Study officials:
affiliation: Institut Català de la Salut
name: José L Ballvé Moreno, MD
role: STUDY_CHAIR
affiliation: IDIAP JORDI GOL
name: Marc Casajuana, Economist
role: STUDY_CHAIR
affiliation: Servicio Aragones De Salud
name: Lourdes Clemente, MD
role: STUDY_CHAIR
affiliation: Institut Català de la Salut
name: Laura Díaz Gete, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IDIAP JORDI GOL
name: Elena M Briones Carrió, Statistician
role: STUDY_CHAIR
affiliation: Institut Català de la Salut
name: Mireia Fàbregas Escurriola, MD
role: STUDY_CHAIR
affiliation: IDIAP JORDI GOL
name: Elisa Puigdomènech Puig, Byologist
role: STUDY_CHAIR
affiliation: Institut Català de la Salut
name: José L del Val, MD
role: STUDY_CHAIR
affiliation: Institut Català de la Salut
name: Soraya Fernández Maestre, nurse
role: STUDY_CHAIR
affiliation: Institut Català de la Salut. Research Unit of Barcelona, IDIAP Jordi Gol. Department of Medicine, University Autonomus of Barcelona
name: Carlos Martín Cantera, MD, Ph D
role: STUDY_CHAIR
affiliation: Family Medicine Research centre School of Health and medical Sciences. Örebro University
name: Ricardo Almon, MD, PhD
role: STUDY_CHAIR
References:
citation: Diaz-Gete L, Puigdomenech E, Briones EM, Fabregas-Escurriola M, Fernandez S, Del Val JL, Ballve JL, Casajuana M, Sanchez-Fondevila J, Clemente L, Castano C, Martin-Cantera C; Grupo Estudio TABATIC. Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial. BMC Public Health. 2013 Apr 18;13:364. doi: 10.1186/1471-2458-13-364.