Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatment spirometry
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

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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)
spirometry
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)
(No Intervention)
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).

Primary Outcomes

Measure
Cessation of tobacco consumption at 12 months.
time frame: 12 months

Secondary Outcomes

Measure
Smoking reduction: self reported reduction
time frame: 12 Months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.