Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- Smoking abstinence: self reported abstinence (12 or more months smoking free.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.
Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.
Expected outcome: increase of smoking cessation rate .
详细描述
Design: Intervention study with two randomized arms in 5 primary care centers of two health areas.
Study population: 466 smokers over the age of 18 consulting their primary care physician for any reason and who do not fulfil the exclusion criteria.
Measurements and interventions: The study data will be collected using a structured questionnaire and data collection sheets specifically designed for the study The structured questionnaire will include the following data: sociodemographics, clinical history, smoking habit, respiratory symptomatology, smoking dependence test and smoking cessation motivation test.
The data collection sheets will include information related to the spirometric results, peak expiratory flow rate and the carbon monoxide test when performed.
On visit 0, the primary care physician will give a brief structured smoking cessation advice to all patients combined with a detailed and structured discussion of the spirometric results. After this visit the patients will be randomised in two arms (control and intervention groups).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult smoker population over the age of 18 years attended by their primary care physician for any reason and who do not fulfil
排除标准
- •Exclusion Criteria:
- •Previous diagnosis of COPD by spirometry.
- •Patients contraindicated to undertake spirometry.
- •Patients without a telephone.
- •Patients with communication difficulties: cognitive and/or sensorial deterioration, language.
- •Patients with severe disease of poor prognosis (life expectancy of less than one year).
- •Patients with another respiratory disease: asthma, COPD, neoplasm of the respiratory tract, pulmonary thromboembolism, pulmonary tuberculosis, interstitial diseases.
- •Patients who do not give written informed consent to participate in the study.
结局指标
主要结局
Smoking abstinence: self reported abstinence (12 or more months smoking free.
时间窗: 24 months after last recruitment
Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No
次要结局
未报告次要终点