Cessation of Smoking, Tobacco Dependence
Conditions
Keywords
Adult, computer-assisted instruction, electronic mail, program evaluation, smoking cessation/methods, continued abstinence
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.
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.
Interventions
OTHERelectronic 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
Preventive Services and Health Promotion Research Network
Public Health Service of Cataluña
Carlos III Health Institute
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in smoking status and maintenance in smoking cessation | the outcome measure is studied at 6 and 12 months | The term used to name long term abstinence over 6 months is continuous abstinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| self-reported smoking reduction | the outcome measure will be studied at 3, 6 and 12 months | In case not reaching abstinence |
| 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 | — |
| self-reported tobacco consumption | the outcome measure is 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 outcome measure will be studied at 3, 6 and 12 months | The estimated cost of helping people to leave smoking in regular conditions |
| point prevalence abstinence | the outcome measure is studied at 3, 6 and 12 months | In case ok not reaching abstinence, will be measured if a subject has changed of stage in transtheoretical model of Prochaska and DiClemente. |
Countries
Spain
Outcome results
None listed