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

NCT01494246 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1064

Last updated 2014-06-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Preventive Services and Health Promotion Research Network

    collaborator OTHER
  • Public Health Service of Cataluña

    collaborator OTHER
  • Carlos III Health Institute

    collaborator OTHER_GOV
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • José L Ballvé Moreno, MD · Institut Català de la Salut

  • Marc Casajuana, Economist · IDIAP JORDI GOL

  • Lourdes Clemente, MD · Servicio Aragones De Salud

  • Laura Díaz Gete, MD · Institut Català de la Salut

  • Elena M Briones Carrió, Statistician · IDIAP JORDI GOL

  • Mireia Fàbregas Escurriola, MD · Institut Català de la Salut

  • Elisa Puigdomènech Puig, Byologist · IDIAP JORDI GOL

  • José L del Val, MD · Institut Català de la Salut

  • Soraya Fernández Maestre, nurse · Institut Català de la Salut

  • 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

  • Ricardo Almon, MD, PhD · Family Medicine Research centre School of Health and medical Sciences. Örebro University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-09-30
Completion
2014-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494246 on ClinicalTrials.gov