Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)

Sponsor
Jordi Gol i Gurina Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT01194596
Collaborator
Catalan Institute of Health (Other), Primary Care Area Tarragona-Reus (Other)
596
1
2
37
16.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smoking cessation advice
  • Behavioral: Spirometry and smoking cessation advice
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
596 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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 Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2010
Anticipated Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spirometry and lifestyle counseling

Intervention group: 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 discussion of the spirometric results.

Behavioral: Spirometry and smoking cessation advice
Intervention group: 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 discussion of the spirometric results.
Other Names:
  • Intervention arm
  • No Intervention: Lifestyle counseling

    No intervention group: 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).

    Behavioral: Smoking cessation advice
    Brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine).
    Other Names:
  • Usual care
  • Outcome Measures

    Primary Outcome Measures

    1. smoking abstinence: self reported abstinence (12 or more months) [12 months]

      smoking abstinence confirmed by an expired air carbon monoxide

    Secondary Outcome Measures

    1. smoking reduction: self reported reduction [12 months]

      smoking reduction by self reported reduction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jordi Gol i Gurina Foundation Barcelona Spain 08007

    Sponsors and Collaborators

    • Jordi Gol i Gurina Foundation
    • Catalan Institute of Health
    • Primary Care Area Tarragona-Reus

    Investigators

    • Principal Investigator: Francisco Martín-Luján, MD, Catalan Institute of Health
    • Study Director: Josep L Piñol-Moreso, PhD, Catalan Institute of Health
    • Study Chair: Josep Basora-Gallisà, MD, Catalan Institute of Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01194596
    Other Study ID Numbers:
    • 4R07/040
    • Jordi Gol i Gurina Foundation
    First Posted:
    Sep 3, 2010
    Last Update Posted:
    Apr 7, 2011
    Last Verified:
    Apr 1, 2011

    Study Results

    No Results Posted as of Apr 7, 2011