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

Tobacco Dependence Clinical Trial

— TABATIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01494246
• Other study ID #: PI11/00817
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 30, 2011
• Last updated: June 18, 2014
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1064
• Est. completion date: December 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cessation of Smoking
• Tobacco Dependence

Intervention

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.

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Carlos III Health Institute, Preventive Services and Health Promotion Research Network, Public Health Service of Cataluña

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Díaz-Gete L, Puigdomènech E, Briones EM, Fàbregas-Escurriola M, Fernandez S, Del Val JL, Ballvé JL, Casajuana M, Sánchez-Fondevila J, Clemente L, Castaño C, Martín-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	self-reported tobacco consumption		the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	self-reported smoking reduction	In case not reaching abstinence	the outcome measure will be studied at 3, 6 and 12 months	Yes
Secondary	stage of change in Prochaska cycle		the outcome measure will be studied at 3,6 and 12 months	Yes
Secondary	used time by professionals to achieve patients stop smoking		the outcome measure will be studied at 3, 6 and 12 months	Yes
Secondary	used time by participants		the outcome measure will be studied at 3, 6 and 12 months	Yes
Secondary	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	Yes