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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Jordi Gol i Gurina Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Catalan Health Institute
Primary Care Area Tarragona-Reus
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01194596
First received: September 2, 2010
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • smoking abstinence: self reported abstinence (12 or more months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    smoking abstinence confirmed by an expired air carbon monoxide


Secondary Outcome Measures:
  • smoking reduction: self reported reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    smoking reduction by self reported reduction


Enrollment: 596
Study Start Date: June 2008
Estimated Study Completion Date: July 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194596

Locations
Spain
Jordi Gol i Gurina Foundation
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Catalan Health Institute
Primary Care Area Tarragona-Reus
Investigators
Principal Investigator: Francisco Martín-Luján, MD Catalan Health Institute
Study Director: Josep L Piñol-Moreso, PhD Catalan Health Institute
Study Chair: Josep Basora-Gallisà, MD Catalan Health Institute
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco Martín-Luján, Catalan Health Institute
ClinicalTrials.gov Identifier: NCT01194596     History of Changes
Other Study ID Numbers: 4R07/040, Jordi Gol i Gurina Foundation
Study First Received: September 2, 2010
Last Updated: April 6, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Jordi Gol i Gurina Foundation:
smoking cessation advice
spirometry
primary health care

ClinicalTrials.gov processed this record on October 19, 2014