Clinical trial NCT01194596: Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)
Official title: Effectiveness of Smoking Cessation Advice Combined With a Detailed Discussion of the Spirometric Results With the Primary Care Practitioner on the Smoking Habit in Adult Smokers (ESPITAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation advice
spirometry
primary health care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Catalan Institute of Health
First posted: 2010-09-03
Enrollment: 596
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: The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care.

Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice.

Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.

Detailed description: Main objective: To evaluate the effectiveness of smoking cessation advice combined with a detailed discussion of the spirometric results with the primary care practitioner on the smoking habit in adult smokers.

Methodology:

Design: Intervention study using a randomised control group. Setting: 12 primary care centres of two health areas. Participants: 600 smokers, aged 35 to 70 years, seeking medical advice from their primary care practitioner (GP) for any given reason (selection visit), excluding those patients with Chronic Obstructive Pulmonary Disease (COPD).

Measurements and interventions: In the selection visit, all participants will be required to undergo a series of tests that will include spirometry, tobacco dependence test, a test to measure the motivation to stop smoking and a structured questionnaire on sociodemographic data, smoking habit, respiratory symptomatology, etc. Based on the spirometric results, patients presenting airflow limitation will be excluded.

Randomisation will be performed using a computer programme. Randomisation will be carried out by the Coordinating Centre.

All other patients will be scheduled for another visit with their primary care practitioner one month later. In this visit (visit 1) and depending on the randomisation into 2 groups, one group will be given brief but structured smoking cessation advice together with a detailed and structured discussion of the spirometric results while the second group will also be given the same brief smoking cessation advice but without discussing the spirometric results. Both groups will be scheduled for a visit at 6 months (visit 2), and at 1 year (visit 3). During visit 2, the patient will be asked about his or her smoking habit. One month before visit 3, patients will be required to undergo again the series of tests performed prior to visit 1. In visit 3, all those patients who claim to have stopped smoking will be required to take a carbon monoxide test.

Eligibility criteria: Inclusion Criteria:

* Adult smoker subjects aged between 35 and 70 years

Exclusion Criteria:

* Previous antecedents of any respiratory disease
* Suffering of any chronic or terminal disorder
* Counterindication to undertake spirometry or that may hinder the performance of the spirometry test

Primary outcomes:
measure: smoking abstinence: self reported abstinence (12 or more 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: Francisco Martín-Luján, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Josep L Piñol-Moreso, PhD
role: STUDY_DIRECTOR
affiliation: Catalan Institute of Health
name: Josep Basora-Gallisà, MD
role: STUDY_CHAIR
References:
citation: Martin-Lujan F, Basora-Gallisa J, Villalobos F, Martin-Vergara N, Aparicio-Llopis E, Pascual-Palacios I, Santigosa-Ayala A, Catalin RE, Rey-Renones C, Sola R; ESPITAP Study Group Investigators. Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study. J Epidemiol Community Health. 2021 Oct;75(10):1001-1009. doi: 10.1136/jech-2020-216219. Epub 2021 Apr 21.
citation: Sorli-Aguilar M, Martin-Lujan F, Flores-Mateo G, Jardi-Pinana C, Aparicio-Llopis E, Basora-Gallisa J, Sola-Alberich R; ESPITAP Study Group investigators. Adiposity markers and lung function in smokers: a cross-sectional study in a Mediterranean population. BMC Pulm Med. 2016 Dec 9;16(1):178. doi: 10.1186/s12890-016-0341-y.
citation: Martin-Lujan F, Pinol-Moreso JL, Martin-Vergara N, Basora-Gallisa J, Pascual-Palacios I, Sagarra-Alamo R, Llopis EA, Basora-Gallisa MT, Pedret-Llaberia R; ESPITAP Study Group investigators. Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study. BMC Public Health. 2011 Nov 11;11:859. doi: 10.1186/1471-2458-11-859.