Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)
Recruitment status was Active, not recruiting
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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) |
- 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
- 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 |
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| Spain | |
| Jordi Gol i Gurina Foundation | |
| Barcelona, Spain, 08007 | |
| 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
Additional 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 |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 22, 2013