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.

Smoking Cessation Clinical Trial

— RESET-ESPITAP2  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02153047
• Other study ID #: PI11/01962
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: June 2023

Study information

• Verified date: March 2024
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: June 2023
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Catalan Institute of Health, Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of tobacco consumption at 12 months.		12 months
Secondary	Smoking reduction: self reported reduction	Smoking reduction by self reported reduction	12 Months