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

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

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 Overview

• Status: Unknown
• Conditions: Tobacco Dependence; Cessation of Smoking
• Intervention / Treatment: Other: electronic mail

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1064
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08007
    • Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: e-mail, electronic mail, computer intervention,
No Intervention: brief advise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Carlos III Health Institute; Preventive Services and Health Promotion Research Network; Public Health Service of Cataluña
• Investigators: 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 Aragones 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): June 19, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Adult; program evaluation; computer-assisted instruction; electronic mail; smoking cessation/methods; continued abstinence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: PI11/00817