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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Public Health Service of Cataluña
Carlos III Health Institute
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01494246
First received: November 30, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Tobacco Dependence
Cessation of Smoking
Other: electronic mail
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Change in smoking status and maintenance in smoking cessation [ Time Frame: the outcome measure is studied at 6 and 12 months ] [ Designated as safety issue: Yes ]
    The term used to name long term abstinence over 6 months is continuous abstinence.


Secondary Outcome Measures:
  • point prevalence abstinence [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    In case ok not reaching abstinence, will be measured if a subject has changed of stage in "transtheoretical model of Prochaska and DiClemente".

  • self-reported tobacco consumption [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • self-reported smoking reduction [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    In case not reaching abstinence

  • stage of change in Prochaska cycle [ Time Frame: the outcome measure will be studied at 3,6 and 12 months ] [ Designated as safety issue: Yes ]
  • used time by professionals to achieve patients stop smoking [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • used time by participants [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • cost to get smoking help in primary care service [ Time Frame: the outcome measure will be studied at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    The estimated cost of helping people to leave smoking in regular conditions


Estimated Enrollment: 1064
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: e-mail, electronic mail, computer intervention,
No Intervention: brief advise

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494246

Locations
Spain
Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Public Health Service of Cataluña
Carlos III Health Institute
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 Aragonés 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
  More Information

Publications:
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01494246     History of Changes
Other Study ID Numbers: PI11/00817
Study First Received: November 30, 2011
Last Updated: June 18, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Adult
computer-assisted instruction
electronic mail
program evaluation
smoking cessation/methods
continued abstinence

ClinicalTrials.gov processed this record on October 29, 2014