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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2023-06-30

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

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Spirometry

Intervention Type BEHAVIORAL

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)

Brief smoking cessation advice

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No