Effectiveness of the Evaluation and Communication of "Pulmonary Age" as Help for Smoking Cessation: a Cluster Randomized Essay
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Rate of smoking cessation at 6 months
研究概览
简要总结
The experimental design is a cluster randomized trial in 2 parallel groups: an intervention group with assessment of the pulmonary age and a control group without.
The population studied is patients aged 25 or more, smoking for more than a year, seen in general practice consultation, for any reason.
The progress of the study will be composed of an inclusion visit (M0) with a pulmonary age estimation for the intervention group and an measurement of the exhaled carbon monoxide for both groups, then a follow-up visit 6 months after the inclusion (M6) with an exhaled carbon monoxide measure for both groups, and a phone call at 12 months (M12) with a quality of life survey for both groups.
The primary outcome is the smoking cessation at 6 months, confirmed by the carbon monoxide exhaled, at a scheduled consultation with the General practitioner (GP).
详细描述
Few scientific studies evaluate the pharmacological and non-pharmacological measurement of pulmonary age for smoking cessation. Moreover, existing research studies provide contradictory results.
DESCRIPTION OF THE RESEARCH METHODOLOGY
Experimental design Cluster randomized controlled trial on the center (= medical practices) in 2 parallel groups (intervention group (pulmonary age estimation) and control group (no pulmonary age estimation)).
National multicentric research:
33 participating centers (= medical practices), located in France. 3 referring physicians (=regional coordinators) were identified to energize the team of investigators and facilitate inclusions. There are 3 in Ile de France and 1 in PACA.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 25 years of age or older
- •Smoker for a year or more
- •Patient giving informed and written consent to participate in the study
- •Patient affiliated to a social security scheme
排除标准
- •Known respiratory illness, chronic or acute in progress or less than 3 weeks old (BPCO, asthma, other respiratory disease
- •Myocardial infarction less than a year
- •Chest or abdominal pain preventing or limiting completion of the forced exhalation maneuver necessary for evaluation of "pulmonary age", whatever the cause
- •Oral or facial pain exacerbated by the mouthing of the mouthpiece
- •Stress urinary incontinence
- •Mental confusion or dementia
- •Pregnant or breastfeeding woman
- •Major protected
- •Do not understand french
研究组 & 干预措施
Usual Care
Usual care + communication of pulmonary age
干预措施: Pulmonary age (Behavioral)
结局指标
主要结局
Rate of smoking cessation at 6 months
时间窗: 6 months
assessed with carbon monoxide measure in exhaled air by ppm
次要结局
- Tobacco cessation rate at 12 months(12 months)
- Assessment of tobacco cessation persistence at 12 months(12 months)
- Tobacco cessation characteristic(6 months -12 months)
- GP acceptability of the pulmonary age tool(6 months)