Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,064
- 试验地点
- 2
- 主要终点
- Change in smoking status and maintenance in smoking cessation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in smoking status and maintenance in smoking cessation
时间窗: the outcome measure is studied at 6 and 12 months
The term used to name long term abstinence over 6 months is continuous abstinence.
次要结局
- point prevalence abstinence(the outcome measure is studied at 3, 6 and 12 months)
- self-reported tobacco consumption(the outcome measure is studied at 3, 6 and 12 months)
- self-reported smoking reduction(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)
- 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)