Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

Study Overview
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Brief Summary
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The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.

Official Title
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Effectiveness of Spirometry and the Report of Spirometric Test Results by a Primary Care Physician on Smoking Cessation Rate in Adult Smokers: a Randomized Controlled Trial.

Conditions
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Smoking Cessation, COPD

Intervention / Treatment
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* Behavioral: Spirometry and a brief advice to quit smoking
* Behavioral: Brief advice to quit smoking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Active smokers over 40 years and more than 10 pack-years Exclusion Criteria: Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern. Patients with limitations in performing spirometry Age greater than 80 years Institutionalized patients Patients with a life expectancy less than 1 year Spirometry in the past 2 years

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 and a brief advice to quit smoking<br>Intervention group: The intervention consists of completing a questionnaire and undergo spirometry with bronchodilator test by a trained nurse. Later, the patients receives a brief advice to quit smoking and a report of the spirometry results by their family doctor. | Behavioral: Spirometry and a brief advice to quit smoking<br>* During a year, recruitment for active smoker patients was done by doctors in primary care medical offices. In the intervention group, after been randomized, one trained nurse completed the questionnaires and did the spirometry with bronchodilator test and set a date with its family doctor who did a minimal smoking cessation counselling intervention and informed the patients about the spirometry results according to established protocol.<br>|
| Active Comparator: Brief advice to quit smoking<br>Control group: Patients in the control group complete a questionnaire by a nurse and then receive a brief advice to quit smoking by their family doctor. | Behavioral: Brief advice to quit smoking<br>* During a year, recruitment for active smokers patients occurred through doctors in primary care medical offices. After be randomized, in de control group, a nurse complete the questionnaires. Below, patients go to the family doctor who will do a minimal smoking cessation counselling intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure of results will be the differences in smoking cessation rates between intervention and control groups | In all patients who report smoking withdrawal, smoking cessation will be confirmed by air carbon monoxide concentration. | 12 months after been conducted the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce the number of cigarettes among those who continue smoking | One secondary outcome will be to reduce the number of cigarettes. In all patients who continue smoking will be recorded the number of cigarettes smoked per day currently | 12 months after been conducted the intervention | 
| Increase smoking abstinence rates in patients with COPD | Evaluate the differences in smoking cessation rates between patients with COPD and those without. | 12 months after been conducted the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirometry, screening, smoking cessation, tobacco, COPD