Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Cessation of tobacco consumption at 12 months.
研究概览
简要总结
There is controversy about the effectiveness of interventions based on spirometry for smoking cessation.
The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care.
This study, is the second half of what was began with ESPITAP study
详细描述
Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not.
Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption.
Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be <10ppm abstinence will be verified by determination of urinary cotinine.
Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the "intent to treat", the unit of analysis will be the smoker.
Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active smokers (consumption>10 packs/year)
排除标准
- •Active respiratory disease
- •Practice of an espirometry on 12 months before
- •Suffering of any chronic or terminal disorder
- •Counterindication to undertake spirometry or that may hinder the performance of the spirometry test
结局指标
主要结局
Cessation of tobacco consumption at 12 months.
时间窗: 12 months
次要结局
- Smoking reduction: self reported reduction(12 Months)