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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. — RESET-ESPITAP2  

Smoking Cessation Clinical Trial

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.

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02153047
Study type Interventional
Source Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Contact
Status Completed
Phase N/A
Start date November 2011
Completion date June 2023
View Details
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