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| Name | Class |
|---|---|
| Preventive Services and Health Promotion Research Network | OTHER |
| Public Health Service of Cataluña | OTHER |
| Carlos III Health Institute | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electronic mail | Experimental |
| |
| brief advise | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| self-reported tobacco consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group. | Barcelona | Barcelona | 08007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23597262 | Background | 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. |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| the outcome measure is studied at 3, 6 and 12 months |
| self-reported smoking reduction | In case not reaching abstinence | 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 |
| used time by participants | the outcome measure will be studied at 3, 6 and 12 months |
| 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 |
| 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 |
| D001519 | Behavior |