Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.

Study Overview
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Brief Summary
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There is controversy about the effectiveness of interventions based on spirometry for smoking cessation. The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care. This study, is the second half of what was began with ESPITAP study

Detailed Description
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Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not. Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption. Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be <10ppm abstinence will be verified by determination of urinary cotinine. Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the intent to treat, the unit of analysis will be the smoker. Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.

Official Title
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Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active smokers (consumption>10 packs/year) Exclusion Criteria: Active respiratory disease Practice of an espirometry on 12 months before 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirometry<br>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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical) | Behavioral: Spirometry<br>* 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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical)<br>|
| No Intervention: Brief smoking cessation advice<br>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 |
| --- | --- | --- |
| Cessation of tobacco consumption at 12 months. |  | 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, Spirometry, Primary health care