Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care. Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice. Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.

Detailed Description
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Main objective: To evaluate the effectiveness of smoking cessation advice combined with a detailed discussion of the spirometric results with the primary care practitioner on the smoking habit in adult smokers. Methodology: Design: Intervention study using a randomised control group. Setting: 12 primary care centres of two health areas. Participants: 600 smokers, aged 35 to 70 years, seeking medical advice from their primary care practitioner (GP) for any given reason (selection visit), excluding those patients with Chronic Obstructive Pulmonary Disease (COPD). Measurements and interventions: In the selection visit, all participants will be required to undergo a series of tests that will include spirometry, tobacco dependence test, a test to measure the motivation to stop smoking and a structured questionnaire on sociodemographic data, smoking habit, respiratory symptomatology, etc. Based on the spirometric results, patients presenting airflow limitation will be excluded. Randomisation will be performed using a computer programme. Randomisation will be carried out by the Coordinating Centre. All other patients will be scheduled for another visit with their primary care practitioner one month later. In this visit (visit 1) and depending on the randomisation into 2 groups, one group will be given brief but structured smoking cessation advice together with a detailed and structured discussion of the spirometric results while the second group will also be given the same brief smoking cessation advice but without discussing the spirometric results. Both groups will be scheduled for a visit at 6 months (visit 2), and at 1 year (visit 3). During visit 2, the patient will be asked about his or her smoking habit. One month before visit 3, patients will be required to undergo again the series of tests performed prior to visit 1. In visit 3, all those patients who claim to have stopped smoking will be required to take a carbon monoxide test.

Official Title
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Effectiveness of Smoking Cessation Advice Combined With a Detailed Discussion of the Spirometric Results With the Primary Care Practitioner on the Smoking Habit in Adult Smokers (ESPITAP)

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking cessation advice
* Behavioral: Spirometry and smoking cessation advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult smoker subjects aged between 35 and 70 years Exclusion Criteria: Previous antecedents of any respiratory disease Suffering of any chronic or terminal disorder Counterindication to undertake spirometry or that may hinder the performance of the spirometry test

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirometry and lifestyle counseling<br>Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results. | Behavioral: Smoking cessation advice<br>* Brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine), will be given in both arms.<br>* Other names: No Intervention arm;Behavioral: Spirometry and smoking cessation advice<br>* Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results.<br>* Other names: Intervention arm;|
| No Intervention: Lifestyle counseling<br>No intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking abstinence: self reported abstinence (12 or more months) | smoking abstinence confirmed by an expired air carbon monoxide | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking reduction: self reported reduction | smoking reduction by self reported reduction | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation advice, spirometry, primary health care