We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01194596
Recruitment Status : Unknown
Verified April 2011 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Active, not recruiting
First Posted : September 3, 2010
Last Update Posted : April 7, 2011
Sponsor:
Collaborators:
Information provided by:

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
Smoking Cessation Behavioral: Smoking cessation advice Behavioral: Spirometry and smoking cessation advice

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  (Clinical Trial)
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 : June 2008
Primary Completion Date : June 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Usual care


Outcome Measures

Primary Outcome Measures :
  1. smoking abstinence: self reported abstinence (12 or more months) [ Time Frame: 12 months ]
    smoking abstinence confirmed by an expired air carbon monoxide


Secondary Outcome Measures :
  1. smoking reduction: self reported reduction [ Time Frame: 12 months ]
    smoking reduction by self reported reduction


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194596


Locations
Spain
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