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

NCT01494246 | Unknown Phase 4 DMC

• 1 other identifier: PI11/00817
• Study Type: interventional
• Target: 1,064
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence; Cessation of Smoking

Keywords

Adult; computer-assisted instruction; electronic mail; program evaluation; smoking cessation/methods; continued abstinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• point prevalence abstinence

  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

  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

Study Arms (2)

electronic mail

EXPERIMENTAL

Other: electronic mail

brief advise

NO INTERVENTION

Interventions

electronic mail 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.

Also known as: e-mail, electronic mail, computer intervention,

electronic mail

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Preventive Services and Health Promotion Research Network: collaborator
• Public Health Service of Cataluña: collaborator
• Carlos III Health Institute: collaborator

Study Sites (1)

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

Barcelona, Barcelona, 08007, Spain

Location

Related Publications (1)

• 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.

  PMID: 23597262 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• José L Ballvé Moreno, MD

  Institut Català de la Salut

  STUDY CHAIR

• Marc Casajuana, Economist

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  STUDY CHAIR

• Lourdes Clemente, MD

  Servicio Aragones De Salud

  STUDY CHAIR

• Laura Díaz Gete, MD

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

• Elena M Briones Carrió, Statistician

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  STUDY CHAIR

• Mireia Fàbregas Escurriola, MD

  Institut Català de la Salut

  STUDY CHAIR

• Elisa Puigdomènech Puig, Byologist

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

ES (1)