Smoking Cessation Clinical Trial
— CAPASTOfficial title:
Effectiveness of the Evaluation and Communication of "Pulmonary Age" as Help for Smoking Cessation: a Cluster Randomized Essay
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).
Status | Recruiting |
Enrollment | 800 |
Est. completion date | March 2026 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Known respiratory illness, chronic or acute in progress or less than 3 weeks old (BPCO, asthma, other respiratory disease - Refusal - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint Antoine | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Kotz D, Wesseling G, Huibers MJ, van Schayck OC. Efficacy of confronting smokers with airflow limitation for smoking cessation. Eur Respir J. 2009 Apr;33(4):754-62. doi: 10.1183/09031936.00116308. Epub 2009 Jan 7. — View Citation
Lorenzo A, Noel F, Lorenzo M, Van Den Broucke J. [The role of spirometry in encouraging smoking cessation in general practice. A pilot study using "lung age"]. Rev Mal Respir. 2017 Sep;34(7):734-741. doi: 10.1016/j.rmr.2016.10.873. Epub 2017 Feb 13. French. — View Citation
Morris JF, Temple W. Spirometric "lung age" estimation for motivating smoking cessation. Prev Med. 1985 Sep;14(5):655-62. doi: 10.1016/0091-7435(85)90085-4. — View Citation
Parkes G, Greenhalgh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ. 2008 Mar 15;336(7644):598-600. doi: 10.1136/bmj.39503.582396.25. Epub 2008 Mar 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of smoking cessation at 6 months | assessed with carbon monoxide measure in exhaled air by ppm | 6 months | |
Secondary | Assessment of tobacco cessation persistence at 12 months | Phone call | 12 months | |
Secondary | Tobacco cessation rate at 12 months | Phone call | 12 months | |
Secondary | Tobacco cessation characteristic | GP consultation-Phone call Survey | 6 months -12 months | |
Secondary | GP acceptability of the pulmonary age tool | assessed with the Likert scale (1-10) | 6 months |
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