A Randomized Open-label Parallel-group Trial is to Analyze the Efficacy and the Efficiency of the Social-Local-Mobile (So-Lo-Mo) Intervention Applied to the Smoking Cessation Process.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- Efficacy: Smoking abstinence rate
研究概览
简要总结
This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. The sample will split in two groups: control group (n=120) who will receive usual psycho-pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-Lo-Mo app.
详细描述
The main objective of this study is to analyze the efficacy and efficiency of the So-Lo-Mo intervention applied to the smoking cessation process compared to usual care.
Secondary objectives are:
- To monitor usual psycho-pharmacological therapies (bupropion, varenicline and behavioural therapy).
- To monitor healthy lifestyle and physical exercise habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoking population attending to the Smoking Cessation Unit of "Virgen del Rocío" University Hospital.
- •Subjects >18 years old who want to give up smoking.
- •Android-based smart phone availability.
- •Ability to interact with the smart phone.
- •To sign an Informed Consent Form.
排除标准
- •Subjects had some previous adverse effects related to the pharmacological treatment included in the study
研究组 & 干预措施
Control
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation.
Prescribed treatments:
- Bupropion pills + Psychological advice
- Varenicline pills + Psychological advice
干预措施: Psychological advice (Behavioral)
Control
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation.
Prescribed treatments:
- Bupropion pills + Psychological advice
- Varenicline pills + Psychological advice
干预措施: Bupropion Pill (Drug)
Control
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation.
Prescribed treatments:
- Bupropion pills + Psychological advice
- Varenicline pills + Psychological advice
干预措施: Varenicline Pill (Drug)
Intervention
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App.
Prescribed treatments:
- Bupropion pills + Psychological advice + So-Lo-Mo
- Varenicline pills + Psychological advice + So-Lo-Mo
干预措施: So-Lo-Mo (Other)
Intervention
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App.
Prescribed treatments:
- Bupropion pills + Psychological advice + So-Lo-Mo
- Varenicline pills + Psychological advice + So-Lo-Mo
干预措施: Psychological advice (Behavioral)
Intervention
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App.
Prescribed treatments:
- Bupropion pills + Psychological advice + So-Lo-Mo
- Varenicline pills + Psychological advice + So-Lo-Mo
干预措施: Bupropion Pill (Drug)
Intervention
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App.
Prescribed treatments:
- Bupropion pills + Psychological advice + So-Lo-Mo
- Varenicline pills + Psychological advice + So-Lo-Mo
干预措施: Varenicline Pill (Drug)
结局指标
主要结局
Efficacy: Smoking abstinence rate
时间窗: 1 year
Smoking abstinence rate at 1 year measured by means of exhaled Carbon Monoxide (CO) and urinary cotinine tests. Subjects with cotinine concentrations \>200 ng/ml or CO \>6 ppm will be considered as smokers.
Efficiency: Incremental Cost-Effectiveness Ratio
时间窗: 1 year
Expressed in terms of Incremental Cost-Effectiveness Ratio (ICER), calculated by dividing the difference in total costs between the intervention group and the control group by the difference in Quality-Adjusted Life Year (QALY) between both groups. Costs associated to control and intervention groups will include healthcare resources utilization measured in terms of specialist consultations related to the smoking cessation process. Costs of pharmacological treatment and time employed by healthcare professionals during the design phase will also be taken into account. Benefit for patients will be expressed in terms of QALY. EuroQol-5D-5L questionnaire will be used to estimate QALY.
次要结局
- Incidence of Treatment-Related Adverse Events [Safety](1 year)
- Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle](From baseline (first evaluation in the study) to 1 year after)
- International Physical Activity Questionnaire (IPAQ27) score [Physical activity](From baseline (first evaluation in the study) to 1 year after)