Smoking CessationESPITAPNCT01194596
Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)
A study testing Smoking cessation advice and Spirometry and smoking cessation advice in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation advice and Spirometry and smoking cessation advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult smoker subjects aged between 35 and 70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation advice, Spirometry and smoking cessation advice
- Keywords
- smoking cessation advice, spirometry, primary health care
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation adviceBehavioural
Also called Usual care, Intervention arm, No Intervention arm
Brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine), will be given in both arms.
Spirometry and smoking cessation adviceBehavioural
Also called Intervention arm
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.
| Study group | Role | What they receive |
|---|---|---|
| Spirometry and lifestyle counseling | Experimental | 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. Receives: Behavioral: Smoking cessation advice; Behavioral: Spirometry and smoking cessation advice |
| Lifestyle counseling | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking abstinence: self reported abstinence (12 or more months)
smoking abstinence confirmed by an expired air carbon monoxide
Measured: 12 months
Secondary outcomes (1)
smoking reduction: self reported reduction
smoking reduction by self reported reduction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Institute of Health
- Responsible party
- Sponsor
- Investigators
- Francisco Martín-Luján, MD, Principal investigator, Catalan Institute of HealthJosep L Piñol-Moreso, PhD, Study director, Catalan Institute of HealthJosep Basora-Gallisà, MD, Study chair, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194596
- Sponsor's protocol ID
- 4R07/040
- Other IDs
- Jordi Gol i Gurina Foundation
- Acronym
- ESPITAP
- Status last verified
- Feb 2023
- First submitted
- 2 Sep 2010
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33883199Sorli-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.
PubMed 27938399Martin-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.
PubMed 22078490
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01194596
- Acronym / sponsor ID
- ESPITAP / 4R07/040
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation advice, spirometry, primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Catalan Institute of Health
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirometry and lifestyle counseling | Experimental | Behavioral: Smoking cessation advice, Behavioral: Spirometry and smoking cessation adviceIntervention 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. |
| Lifestyle counseling | No intervention | –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). |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult smoker subjects aged between 35 and 70 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation adviceAlso: Usual care, Intervention arm, No Intervention armBrief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine), will be given in both arms. | Behavioural | Spirometry and lifestyle counseling |
| Spirometry and smoking cessation adviceAlso: Intervention armIntervention 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. | Behavioural | Spirometry and lifestyle counseling |
Primary outcome
smoking abstinence: self reported abstinence (12 or more months)
Time frame: 12 months
smoking abstinence confirmed by an expired air carbon monoxide
1 secondary outcome
smoking reduction: self reported reduction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 33883199Martin-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.
- Derived from this study: PubMed 27938399Sorli-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.
- Derived from this study: PubMed 22078490Martin-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.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Martín-Luján, MD principal investigator
Catalan Institute of Health
Josep L Piñol-Moreso, PhD study director
Catalan Institute of Health
Josep Basora-Gallisà, MD study chair
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation advice and Spirometry and smoking cessation advice in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking abstinence: self reported abstinence (12 or more months) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01194596, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.