Smoking CessationRESET-ESPITAP2NCT02153047
Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.
A study testing Spirometry in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
There is controversy about the effectiveness of interventions based on spirometry for smoking cessation. The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice 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?
- Spirometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Jun 2023
- 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
- Active smokers (consumption>10 packs/year)
Who cannot join
- Active respiratory disease
- Practice of an espirometry on 12 months before
- 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
There is controversy about the effectiveness of interventions based on spirometry for smoking cessation.
The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care.
This study, is the second half of what was began with ESPITAP study
Read the detailed description
Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not.
Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption.
Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be <10ppm abstinence will be verified by determination of urinary cotinine.
Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the "intent to treat", the unit of analysis will be the smoker.
Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.
- Conditions
- Smoking Cessation
- Being tested
- Spirometry
- Keywords
- Smoking cessation, 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.
SpirometryBehavioural
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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical)
| Study group | Role | What they receive |
|---|---|---|
| Spirometry | Experimental | 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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical) Receives: Behavioral: Spirometry |
| Brief smoking cessation advice | No intervention | 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.
Cessation of tobacco consumption at 12 months.
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 posted2 Jun 2014 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Catalan Institute of Health
- Responsible party
- Sponsor
- Investigators
- Antoni Santigosa-Ayala, MD, Principal investigator, Catalan Institute of HealthFrancisco Martín-Luján, PhD, Study director, Catalan Institute of HealthRosa Sola-Alberich, MD, Study chair, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153047
- Sponsor's protocol ID
- PI11/01962
- Acronym
- RESET-ESPITAP2
- Status last verified
- Mar 2024
- First submitted
- 28 May 2014
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin-Lujan F, Santigosa-Ayala A, Palleja-Millan M, Rey-Renones C, Villalobos F, Sola R; researchers of the RESET study. Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial. Eur J Gen Pract. 2023 Dec;29(1):2276764. doi: 10.1080/13814788.2023.2276764. Epub 2023 Nov 7.
PubMed 37933978Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Sorli-Aguilar M, Flores-Mateo G, Blade-Creixenti J, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol. BMC Fam Pract. 2016 Feb 4;17:15. doi: 10.1186/s12875-016-0415-1.
PubMed 26846522
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.
- ClinicalTrials.gov ID
- NCT02153047
- Acronym / sponsor ID
- RESET-ESPITAP2 / PI11/01962
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Spirometry, Primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Catalan Institute of Health
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 2 Jun 2014 (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.
There is controversy about the effectiveness of interventions based on spirometry for smoking cessation.
The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care.
This study, is the second half of what was began with ESPITAP study
Detailed description
Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not.
Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption.
Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be <10ppm abstinence will be verified by determination of urinary cotinine.
Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the "intent to treat", the unit of analysis will be the smoker.
Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirometry | Experimental | Behavioral: SpirometryWill 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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical) |
| Brief smoking cessation advice | No intervention | –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)
- Active smokers (consumption>10 packs/year)
Key exclusion criteria (4 listed)
- Active respiratory disease
- Practice of an espirometry on 12 months before
- 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 |
|---|---|---|
| SpirometryWill 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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical) | Behavioural | Spirometry |
Primary outcome
Cessation of tobacco consumption at 12 months.
Time frame: 12 months
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 8 May 2024.
- Derived from this study: PubMed 37933978Martin-Lujan F, Santigosa-Ayala A, Palleja-Millan M, Rey-Renones C, Villalobos F, Sola R; researchers of the RESET study. Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial. Eur J Gen Pract. 2023 Dec;29(1):2276764. doi: 10.1080/13814788.2023.2276764. Epub 2023 Nov 7.
- Derived from this study: PubMed 26846522Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Sorli-Aguilar M, Flores-Mateo G, Blade-Creixenti J, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol. BMC Fam Pract. 2016 Feb 4;17:15. doi: 10.1186/s12875-016-0415-1.
Related trials for Smoking Cessation
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
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.
Antoni Santigosa-Ayala, MD principal investigator
Catalan Institute of Health
Francisco Martín-Luján, PhD study director
Catalan Institute of Health
Rosa Sola-Alberich, 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 Spirometry 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 4 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 8 May 2024. 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?
Cessation of tobacco consumption at 12 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 NCT02153047, which also lists 2 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 8 May 2024.