Smoking CessationESPIROTABNCT01296295
Effectiveness of Regular Reporting of Spirometric Results on Smoking Quit Rate.
A study testing Lifestyle counseling and spirometry and Smoking cessation advice in people with Smoking Cessation and COPD, 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 regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, COPD
- What is being tested?
- Lifestyle counseling 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
- 466 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult smoker population over the age of 18 years attended by their primary care physician for any reason and who do not fulfil exclusion criteria
Who cannot join
- Previous diagnosis of COPD by spirometry.
- Patients contraindicated to undertake spirometry.
- Patients without a telephone.
- Patients with communication difficulties: cognitive and/or sensorial deterioration, language.
- Patients with severe disease of poor prognosis (life expectancy of less than one year).
- Patients with another respiratory disease: asthma, COPD, neoplasm of the respiratory tract, pulmonary thromboembolism, pulmonary tuberculosis, interstitial diseases.
- Patients who do not give written informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.
The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.
Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.
Expected outcome: increase of smoking cessation rate .
Read the detailed description
Design: Intervention study with two randomized arms in 5 primary care centers of two health areas.
Study population: 466 smokers over the age of 18 consulting their primary care physician for any reason and who do not fulfil the exclusion criteria.
Measurements and interventions: The study data will be collected using a structured questionnaire and data collection sheets specifically designed for the study The structured questionnaire will include the following data: sociodemographics, clinical history, smoking habit, respiratory symptomatology, smoking dependence test and smoking cessation motivation test.
The data collection sheets will include information related to the spirometric results, peak expiratory flow rate and the carbon monoxide test when performed.
On visit 0, the primary care physician will give a brief structured smoking cessation advice to all patients combined with a detailed and structured discussion of the spirometric results. After this visit the patients will be randomised in two arms (control and intervention groups).
Randomisation will be performed using a computer programme.
Randomisation will be carried out by the Coordinating Centre.
Both groups will be followed up by telephone at three (visit 1) and six months (visit 2) and at one-year (visit 3) and two-year(visit 4).
During the follow up visits brief structured smoking cessation advice will be reinforced in the control group but the spirometric results will not be discussed. In the intervention group brief structured smoking cessation advice will be reinforced with a detailed structured reminder discussion of the results obtained from the spyrometry of visit 0.
Follow up visits 1 and 2 will be undertaken by telephone and the patients will be asked about their smoking habit and will be given a brief questionnaire.
One month before visits 3 and 4 both groups will undergo the same series of tests performed prior to visit 0 with the exception of the peak expiratory flow rate. Spirometry will be done only in the intervention group.
On visits 3 and 4, the same intervention will be done. On both visits 3 and 4 all the participants who report smoking withdrawal will undergo the carbon monoxide test.
- Conditions
- Smoking Cessation, COPD
- Being tested
- Lifestyle counseling and spirometry, Smoking cessation advice
- Keywords
- smoking cessation advice, spirometry, primary health care
- Medical subject headings
- Smoking Cessation, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counseling and spirometryBehavioural
The patients of the intervention group will be given a brief structured smoking cessation advice by their primary care physician combined with a detailed and structured discussion of the spirometry results.
Smoking cessation adviceBehavioural
Brief smoking cessation advice
| Study group | Role | What they receive |
|---|---|---|
| Spirometry and lifestyle counseling | Experimental | Intervention group: The intervention is to give brief structured smoking cessation advice combined with a detailed and structured discussion of the spirometric results. Receives: Behavioral: Lifestyle counseling and spirometry |
| Lifestyle counseling | No intervention | No intervention group: the patients of the control group will receive a brief structured smoking cessation advice. Receives: Behavioral: Smoking cessation advice |
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 free.
Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No
Measured: 24 months after last recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJan 2005
- Primary completionDec 2010
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- None (open label)
- Enrolment
- 466 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, Research Support Unit Metropolitana Nord, Barcelona, Spain
- Investigators
- Mar Rodriguez, Principal investigator, Institut Catalá de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296295
- Sponsor's protocol ID
- P10/40.
- Other IDs
- Jordi Gol i Gurina Foundation
- Acronym
- ESPIROTAB
- Status last verified
- Feb 2011
- First submitted
- 30 Jul 2010
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez-Alvarez M, Toran-Monserrat P, Munoz-Ortiz L, Negrete-Palma A, Montero-Alia JJ, Jimenez-Gonzalez M, Zurilla-Leonarte E, Marina-Ortega V, Olle-Borque M, Valentin-Moya E, Cortada-Cabrera A, Tena-Domingo A, Martinez-Gonzalez S, Vila-Palau V, Ramos-Ordonez A, Rotllant-Estelrich G, Forcada-Vega C, Borrell-Thio E. Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study. BMC Fam Pract. 2011 Jun 28;12:61. doi: 10.1186/1471-2296-12-61.
PubMed 21708047
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01296295
- Acronym / sponsor ID
- ESPIROTAB / P10/40.
- Conditions
- Smoking Cessation, COPD
- Keywords
- smoking cessation advice, spirometry, primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Catalan Institute of Health, Research Support Unit Metropolitana Nord, Barcelona, Spain
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (estimated)
- First posted
- 15 Feb 2011 (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 regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.
Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.
Expected outcome: increase of smoking cessation rate .
Detailed description
Design: Intervention study with two randomized arms in 5 primary care centers of two health areas.
Study population: 466 smokers over the age of 18 consulting their primary care physician for any reason and who do not fulfil the exclusion criteria.
Measurements and interventions: The study data will be collected using a structured questionnaire and data collection sheets specifically designed for the study The structured questionnaire will include the following data: sociodemographics, clinical history, smoking habit, respiratory symptomatology, smoking dependence test and smoking cessation motivation test.
The data collection sheets will include information related to the spirometric results, peak expiratory flow rate and the carbon monoxide test when performed.
On visit 0, the primary care physician will give a brief structured smoking cessation advice to all patients combined with a detailed and structured discussion of the spirometric results. After this visit the patients will be randomised in two arms (control and intervention groups).
Randomisation will be performed using a computer programme.
Randomisation will be carried out by the Coordinating Centre.
Both groups will be followed up by telephone at three (visit 1) and six months (visit 2) and at one-year (visit 3) and two-year(visit 4).
During the follow up visits brief structured smoking cessation advice will be reinforced in the control group but the spirometric results will not be discussed. In the intervention group brief structured smoking cessation advice will be reinforced with a detailed structured reminder discussion of the results obtained from the spyrometry of visit 0.
Follow up visits 1 and 2 will be undertaken by telephone and the patients will be asked about their smoking habit and will be given a brief questionnaire.
One month before visits 3 and 4 both groups will undergo the same series of tests performed prior to visit 0 with the exception of the peak expiratory flow rate. Spirometry will be done only in the intervention group.
On visits 3 and 4, the same intervention will be done. On both visits 3 and 4 all the participants who report smoking withdrawal will undergo the carbon monoxide test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirometry and lifestyle counseling | Experimental | Behavioral: Lifestyle counseling and spirometryIntervention group: The intervention is to give brief structured smoking cessation advice combined with a detailed and structured discussion of the spirometric results. |
| Lifestyle counseling | No intervention | Behavioral: Smoking cessation adviceNo intervention group: the patients of the control group will receive a brief structured smoking cessation advice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult smoker population over the age of 18 years attended by their primary care physician for any reason and who do not fulfil exclusion criteria
Key exclusion criteria (7 listed)
- Previous diagnosis of COPD by spirometry.
- Patients contraindicated to undertake spirometry.
- Patients without a telephone.
- Patients with communication difficulties: cognitive and/or sensorial deterioration, language.
- Patients with severe disease of poor prognosis (life expectancy of less than one year).
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 |
|---|---|---|
| Lifestyle counseling and spirometryThe patients of the intervention group will be given a brief structured smoking cessation advice by their primary care physician combined with a detailed and structured discussion of the spirometry results. | Behavioural | Spirometry and lifestyle counseling |
| Smoking cessation adviceBrief smoking cessation advice | Behavioural | Lifestyle counseling |
Primary outcome
Smoking abstinence: self reported abstinence (12 or more months smoking free.
Time frame: 24 months after last recruitment
Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
- Derived from this study: PubMed 21708047Rodriguez-Alvarez M, Toran-Monserrat P, Munoz-Ortiz L, Negrete-Palma A, Montero-Alia JJ, Jimenez-Gonzalez M, Zurilla-Leonarte E, Marina-Ortega V, Olle-Borque M, Valentin-Moya E, Cortada-Cabrera A, Tena-Domingo A, Martinez-Gonzalez S, Vila-Palau V, Ramos-Ordonez A, Rotllant-Estelrich G, Forcada-Vega C, Borrell-Thio E. Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study. BMC Fam Pract. 2011 Jun 28;12:61. doi: 10.1186/1471-2296-12-61.
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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.
Mar Rodriguez principal investigator
Institut Catalá de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling and spirometry and Smoking cessation advice in people with Smoking Cessation and COPD, 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 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2011. 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?
Results are not available in the source record.
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 smoking free. (time frame: 24 months after last recruitment). 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 NCT01296295, which also lists 1 linked publication.
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 15 Feb 2011.