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

NCT ID: NCT01494246

Last Updated: 2014-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1064 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Tobacco Dependence; Cessation of Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

electronic mail

Group Type: EXPERIMENTAL

electronic mail

Intervention Type: OTHER

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.

brief advise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

e-mail, electronic mail, computer intervention,

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Preventive Services and Health Promotion Research Network

OTHER

Sponsor Role: collaborator

Public Health Service of Cataluña

OTHER

Sponsor Role: collaborator

Carlos III Health Institute

OTHER_GOV

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José L Ballvé Moreno, MD

Role: STUDY_CHAIR

Institut Català de la Salut

Marc Casajuana, Economist

Role: STUDY_CHAIR

IDIAP JORDI GOL

Lourdes Clemente, MD

Role: STUDY_CHAIR

Servicio Aragones De Salud

Laura Díaz Gete, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut

Elena M Briones Carrió, Statistician

Role: STUDY_CHAIR

IDIAP JORDI GOL

Mireia Fàbregas Escurriola, MD

Role: STUDY_CHAIR

Institut Català de la Salut

Elisa Puigdomènech Puig, Byologist

Role: STUDY_CHAIR

IDIAP JORDI GOL

José L del Val, MD

Role: STUDY_CHAIR

Institut Català de la Salut

Soraya Fernández Maestre, nurse

Role: STUDY_CHAIR

Institut Català de la Salut

Carlos Martín Cantera, MD, Ph D

Role: STUDY_CHAIR

Institut Català de la Salut. Research Unit of Barcelona, IDIAP Jordi Gol. Department of Medicine, University Autonomus of Barcelona

Ricardo Almon, MD, PhD

Role: STUDY_CHAIR

Family Medicine Research centre School of Health and medical Sciences. Örebro University

Locations

Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 23597262 (View on PubMed)

Other Identifiers

PI11/00817

Identifier Type: -

Identifier Source: org_study_id