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Active (not recruiting) Not applicable NCT04276116

Effectiveness of the Evaluation and Communication of "Pulmonary Age" as Help for Smoking Cessation

No applicable phase (e.g. observational)
Conditions: Smoking Cessation

Sponsor: Assistance Publique - Hôpitaux de Paris

trial.available_in: БГ
Overview
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).
Description
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)): 1. a group providing routine smoking cessation management (control group), which will not receive any specific guidance on the means to be used in this management. 2. a group providing routine smoking cessation management, accompanied by estimation and communication to the patient of the pulmonary age, measured using a PulmoLife electronic device. (Intervention Group) 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: * socio-demographic data: age, sex, family situation, level of education, occupation, health insurance coverage (yes/no) * overall health and co-morbidities * smoking history: age of smoking onset, current number of cigarettes per day, average number of cigarettes since smoking began * the number of withdrawal attempts, the maximum duration of withdrawal, the methods used, the date of the last attempt * nicotine dependence (short Fagerström test), motivation to stop (Prochaska) * chronic pathologies * other addictions: collection of cannabis consumption * respiratory symptoms (GOLD-CNAM questionnaire) * overall health status (EQ-5D questionnaire)
Who can participate
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
Interventions
Pulmonary age
BEHAVIORAL
Locations 1
France (1)
Hôpital Saint Antoine
Paris
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
25 Years
Healthy volunteers
No
Start date
27.10.2023
Completion date
30.06.2026
Registry ID
NCT04276116
Source
clinicaltrials.gov
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