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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02060-57 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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).
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.
Randomization
General practitioners who agree to participate in this study will be randomized according to a computerized procedure and centralized in 2 groups (=randomization in a cluster on the center (medical office)):
Consenting patients will then receive smoking cessation assistance from their physician according to the randomization arm in which the physician is assigned (usual versus usual management + pulmonary age estimate and patient information). Patients will be called to the doctor's office 6 months later to measure the expired CO and complete a questionnaire on their tobacco consumption.
RESEARCH PROCESS
Patients will be invited to participate in the study by the general practitioner during a consultation, regardless of the reason for the consultation (tobacco-related or not)
Inclusion visit (M0)
During this visit, the inclusion and non-inclusion criteria will be verified. The general practitioner will present the study to the patient in detail (an information note on the study will have been given to him/her beforehand in the waiting room). If the patient agrees to participate in the study, his or her informed and written consent will be obtained.
The information collected by the general practitioner will be:
It should be noted that whatever the group, the doctor will follow the patient according to current recommendations and his usual practice of managing smoking cessation.
6-month follow-up visit (+/- 15 days) (M6)
This visit will take place in both groups, 6 months +/- 15 days after the patient's inclusion.
During this visit, the doctor will collect:
current smoking status (over the last 15 days)
the measurement of expired CO
the number of withdrawals attempts since inclusion, the duration of the attempts, the average number of cigarettes per day over the period
the withdrawal assistance methods used during the period
respiratory symptoms (GOLD-CNAM questionnaire)
overall health status (EQ-5D questionnaire)
intercurrent events
the number of visits to the physician
12 months visit (+/- 15 days) (M12)
During this visit (which will be made in the 2 groups of patients), will be collected by the doctor:
This visit will correspond to the end of the patient's participation in the study.
EFFECTIVENESS EVALUATION
Description of efficacy evaluation parameters
The parameters for evaluating the effectiveness of the intervention are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | ||
| Usual care + communication of pulmonary age | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary age | Behavioral | Communication of pulmonary age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of smoking cessation at 6 months | assessed with carbon monoxide measure in exhaled air by ppm | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of tobacco cessation persistence at 12 months | Phone call | 12 months |
| Tobacco cessation rate at 12 months | Phone call | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Roche, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Antoine | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18326503 | Background | 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. | |
| 28209422 | Background | 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. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Tobacco cessation characteristic | GP consultation-Phone call Survey | 6 months -12 months |
| GP acceptability of the pulmonary age tool | assessed with the Likert scale (1-10) | 6 months |
| 19129277 | Background | 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. |
| 4070195 | Background | 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. |