Smoking CessationESPIMOATNCT01821885
Effectiveness of Spirometry as a Motivational Tool to Quit Smoking
A study testing Spirometry and a brief advice to quit smoking and Brief advice to quit smoking in people with Smoking Cessation and COPD, run by Basque Health Service at 1 site in Spain.
Trial summary
The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Smoking Cessation, COPD
- What is being tested?
- Spirometry and a brief advice to quit smoking and Brief advice to quit smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Jan 2015
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active smokers over 40 years and more than 10 pack-years
Who cannot join
- Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern.
- Patients with limitations in performing spirometry
- Age greater than 80 years
- Institutionalized patients
- Patients with a life expectancy less than 1 year
- Spirometry in the past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Spirometry and the Report of Spirometric Test Results by a Primary Care Physician on Smoking Cessation Rate in Adult Smokers: a Randomized Controlled Trial.
The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.
- Conditions
- Smoking Cessation, COPD
- Being tested
- Spirometry and a brief advice to quit smoking, Brief advice to quit smoking
- Keywords
- Spirometry, screening, smoking cessation, tobacco, COPD
- 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.
Spirometry and a brief advice to quit smokingBehavioural
During a year, recruitment for active smoker patients was done by doctors in primary care medical offices. In the intervention group, after been randomized, one trained nurse completed the questionnaires and did the spirometry with bronchodilator test and set a date with its family doctor who did a minimal smoking cessation counselling intervention and informed the patients about the spirometry results according to established protocol.
Brief advice to quit smokingBehavioural
During a year, recruitment for active smokers patients occurred through doctors in primary care medical offices. After be randomized, in de control group, a nurse complete the questionnaires. Below, patients go to the family doctor who will do a minimal smoking cessation counselling intervention.
| Study group | Role | What they receive |
|---|---|---|
| Spirometry and a brief advice to quit smoking | Experimental | Intervention group:
The intervention consists of completing a questionnaire and undergo spirometry with bronchodilator test by a trained nurse. Later, the patients receives a brief advice to quit smoking and a report of the spirometry results by their family doctor. Receives: Behavioral: Spirometry and a brief advice to quit smoking |
| Brief advice to quit smoking | Active comparator | Control group:
Patients in the control group complete a questionnaire by a nurse and then receive a brief advice to quit smoking by their family doctor. Receives: Behavioral: Brief advice to quit smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure of results will be the differences in smoking cessation rates between intervention and control groups
In all patients who report smoking withdrawal, smoking cessation will be confirmed by air carbon monoxide concentration.
Measured: 12 months after been conducted the intervention
Secondary outcomes (2)
Reduce the number of cigarettes among those who continue smoking
One secondary outcome will be to reduce the number of cigarettes. In all patients who continue smoking will be recorded the number of cigarettes smoked per day currently
Measured: 12 months after been conducted the intervention
Increase smoking abstinence rates in patients with COPD
Evaluate the differences in smoking cessation rates between patients with COPD and those without.
Measured: 12 months after been conducted the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionJan 2015
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
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mº Isabel Irizar Aramburu, Basque Health Service
- Investigators
- Mª Isabel Irizar Aramburu, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821885
- Sponsor's protocol ID
- 2011111013
- Other IDs
- KRONIK11/071 - EJGV 2011111013
- Acronym
- ESPIMOAT
- Status last verified
- Jan 2015
- First submitted
- 27 Mar 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
Publications
Irizar-Aramburu MI, Martinez-Eizaguirre JM, Pacheco-Bravo P, Diaz-Atienza M, Aguirre-Arratibel I, Pena-Pena MI, Alba-Latorre M, Galparsoro-Goikoetxea M. Effectiveness of spirometry as a motivational tool for smoking cessation: a clinical trial, the ESPIMOAT study. BMC Fam Pract. 2013 Dec 5;14:185. doi: 10.1186/1471-2296-14-185.
PubMed 24308728
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Spirometry and the Report of Spirometric Test Results by a Primary Care Physician on Smoking Cessation Rate in Adult Smokers: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01821885
- Acronym / sponsor ID
- ESPIMOAT / 2011111013
- Conditions
- Smoking Cessation, COPD
- Keywords
- Spirometry, screening, smoking cessation, tobacco, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Apr 2013 (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 aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirometry and a brief advice to quit smoking | Experimental | Behavioral: Spirometry and a brief advice to quit smokingIntervention group: The intervention consists of completing a questionnaire and undergo spirometry with bronchodilator test by a trained nurse. Later, the patients receives a brief advice to quit smoking and a report of the spirometry results by their family doctor. |
| Brief advice to quit smoking | Active comparator | Behavioral: Brief advice to quit smokingControl group: Patients in the control group complete a questionnaire by a nurse and then receive a brief advice to quit smoking by their family doctor. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active smokers over 40 years and more than 10 pack-years
Key exclusion criteria (6 listed)
- Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern.
- Patients with limitations in performing spirometry
- Age greater than 80 years
- Institutionalized patients
- Patients with a life expectancy less than 1 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 |
|---|---|---|
| Spirometry and a brief advice to quit smokingDuring a year, recruitment for active smoker patients was done by doctors in primary care medical offices. In the intervention group, after been randomized, one trained nurse completed the questionnaires and did the spirometry with bronchodilator test and set a date with its family doctor who did a minimal smoking cessation counselling intervention and informed the patients about the spirometry results according to established protocol. | Behavioural | Spirometry and a brief advice to quit smoking |
| Brief advice to quit smokingDuring a year, recruitment for active smokers patients occurred through doctors in primary care medical offices. After be randomized, in de control group, a nurse complete the questionnaires. Below, patients go to the family doctor who will do a minimal smoking cessation counselling intervention. | Behavioural | Brief advice to quit smoking |
Primary outcome
The primary measure of results will be the differences in smoking cessation rates between intervention and control groups
Time frame: 12 months after been conducted the intervention
In all patients who report smoking withdrawal, smoking cessation will be confirmed by air carbon monoxide concentration.
2 secondary outcomes
Reduce the number of cigarettes among those who continue smoking
Time frame: 12 months after been conducted the intervention
Increase smoking abstinence rates in patients with COPD
Time frame: 12 months after been conducted the intervention
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 Jan 2015.
- Derived from this study: PubMed 24308728Irizar-Aramburu MI, Martinez-Eizaguirre JM, Pacheco-Bravo P, Diaz-Atienza M, Aguirre-Arratibel I, Pena-Pena MI, Alba-Latorre M, Galparsoro-Goikoetxea M. Effectiveness of spirometry as a motivational tool for smoking cessation: a clinical trial, the ESPIMOAT study. BMC Fam Pract. 2013 Dec 5;14:185. doi: 10.1186/1471-2296-14-185.
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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.
Mª Isabel Irizar Aramburu principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry and a brief advice to quit smoking and Brief advice to quit smoking in people with Smoking Cessation and COPD, run by Basque Health Service 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 6 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 Jan 2015. 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?
The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (time frame: 12 months after been conducted the intervention). 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 NCT01821885, 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 27 Jan 2015.