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.
This trial is active, not recruiting.
|Sponsor||Jordi Gol i Gurina Foundation|
|Collaborator||Preventive Services and Health Promotion Research Network redIAPP G03/70|
|Start date||November 2011|
|End date||November 2013|
|Trial size||1100 participants|
|Trial identifier||NCT02153047, PI11/01962|
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
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Cessation of tobacco consumption at 12 months.
time frame: 12 months
Smoking reduction: self reported reduction
time frame: 12 Months
Male or female participants from 35 years up to 70 years old.
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
|Official title||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.|
|Principal investigator||Antoni Santigosa-Ayala, MD|
|Description||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.|
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