Clinical trial NCT02153047: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Spirometry
Primary health care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Catalan Institute of Health
First posted: 2014-06-02
Enrollment: 1100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cessation of tobacco consumption at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Smoking reduction: self reported reduction
timeFrame: 12 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Jordi Gol i Gurina Foundation
Study officials:
affiliation: Catalan Institute of Health
name: Antoni Santigosa-Ayala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Francisco Martín-Luján, PhD
role: STUDY_DIRECTOR
affiliation: Catalan Institute of Health
name: Rosa Sola-Alberich, MD
role: STUDY_CHAIR
References:
citation: Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Sorli-Aguilar M, Flores-Mateo G, Blade-Creixenti J, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. 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: the RESET study protocol. BMC Fam Pract. 2016 Feb 4;17:15. doi: 10.1186/s12875-016-0415-1.