A Phase 4 interventional study of electronic mail in Tobacco Dependence and Cessation of Smoking, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-19.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Phase 4 and Interventional
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's planned enrollment of 1,064 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: e-mail, electronic mail, computer intervention,
Change in smoking status and maintenance in smoking cessation
The term used to name long term abstinence over 6 months is continuous abstinence.
Time frame: the outcome measure is studied at 6 and 12 months
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".
Time frame: the outcome measure is studied at 3, 6 and 12 months
self-reported tobacco consumption
Time frame: the outcome measure is studied at 3, 6 and 12 months
self-reported smoking reduction
In case not reaching abstinence
Time frame: the outcome measure will be studied at 3, 6 and 12 months
stage of change in Prochaska cycle
Time frame: the outcome measure will be studied at 3,6 and 12 months
used time by professionals to achieve patients stop smoking
Time frame: the outcome measure will be studied at 3, 6 and 12 months
used time by participants
Time frame: 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
Time frame: the outcome measure will be studied at 3, 6 and 12 months
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina