Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care

NCT ID: NCT03377738

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is analyze if spirometry is a motivational element for changes in the cessation phases of the tobacco habit, compared with not done spirometry.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

According to data from the last INE health survey carried out in 2006, 31.4% of males and 22.3 % of females smoked, in other words more than 26% of the population were smokers. In the Region of Murcia, according to the same Health Survey, the data are even higher than those of Spain, with figures for male smokers at 36.25% and 23.31% for women, with an overall prevalence rate of nearly 30%.

In light of these data, it is necessary to carry out intervention to help tobacco cessation and in this regard,the 98% of smokers trying to quit on their own without any specific support do not achieve their goal.

Interventions at Primary Care Consultations we have two useful tools at our disposal: One of these is brief advice It should be firm, understandable, individualized, verbal and direct. It should last between 3 and 5 minutes and be eminently positive, highlighting the advantages of becoming an ex-smoker. This intervention vs non intervention have an OR=1.69 (IC 95%1.45-1.98). The other intervention we have in an intensive. This includes providing systematic anti-tobacco advice accompanied by written documentation and psychological support as well as the follow-up of patients in their dishabituation process, with a periodicity which varies according to different studies, although to do this more time will have to be dedicated in the consultation.

As more intense intervention on these patients as efficacy obtained is higher, increasing abstinence rates significantly.

Appropriate interventions based on stage of change are based on the transtheoretical model of Prochaska and DiClemente. Smokers are at one stage or another in terms of lesser or greater degree of motivation to quit being closely related to the phases of abandonment of tobacco.

In addition to these tools, two other interventions have been studied which could be useful for increasing cessation rates. In this regard, a Cochrane review determined the efficiency of the evaluation of biomedical risks and different levels of assessment used as a cessation tool for quitting the tobacco habit. The information from eleven trials was analyzed and in three of them spirometry and co-oximetry were used as motivational elements for tobacco cessation. However, the results were inconclusive due to the heterogeneity of the studies, but concludes that it is possible to further improve the methodological quality of studies aimed at evaluating the effectiveness of biomedical risk assessment, including spirometry, as an aid to quit smoking. Other studies also seen as a considerable number of smokers get smoking quit after learning their spirometric results.

For all of these reasons, it is necessary to carry out interventions which help to encourage tobacco habit cessation and in this regard this study has been designed, in which it is intended to assess spirometry , as a motivational element in the phase of tobacco cessation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Cessation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Spirometry Primary care Smoking Cessations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

anti-smoking therapy

All patients will be given only an intervention for tobacco cessation which will depend on the individual's cessation phase

Group Type NO_INTERVENTION

No interventions assigned to this group

anti-smoking therapy + spirometry

All patients will be given an intervention for tobacco cessation which will depend on the individual's cessation phase. In addition, in this group will be given a spirometry test as a motivational element for dishabituation.

Group Type EXPERIMENTAL

spirometry

Intervention Type DIAGNOSTIC_TEST

All patients will be given an intervention for tobacco cessation which will depend on the individual's cessation phase and will be given a spirometry test as a motivational element for dishabituation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spirometry

All patients will be given an intervention for tobacco cessation which will depend on the individual's cessation phase and will be given a spirometry test as a motivational element for dishabituation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* An active smoker
* Aged between 40 and 75 years
* No diagnosis of acute or chronic respiratory disease

Exclusion Criteria

* Serious or terminal diseases
* Limiting osteoarticular diseases
* Serious mental diseases: Psychosis
* Serious depressive disorder
* Neurosis
* Addiction to drugs/alcohol
* Displaced patients (not habitual residents)
* Pregnancy
* Spirometry carried out for any reason in the year prior to inclusion in the study.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MurciaSalud

OTHER_GOV

Sponsor Role collaborator

Public Health Service, Murcia

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

A Lopez-santiago, MD

Role: PRINCIPAL_INVESTIGATOR

Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Murcia, Murcia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Instituto Nacional de Estadística INE. Encuesta Nacional de Salud 2006.

Reference Type BACKGROUND

Ruiz CA, Pinedo AR, Miranda JA, Bermudez JA. [Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) annual campaign for 2007: the year for smoking prevention and control]. Arch Bronconeumol. 2007 Aug;43(8):423-4. doi: 10.1016/s1579-2129(07)60097-4. No abstract available. Spanish.

Reference Type BACKGROUND
PMID: 17692241 (View on PubMed)

Saiz Martinez-Acitores I, Rubio Colavida J, Espiga Lopez I, Alonso de la Iglesia B, Blanco Aguilar J, Cortes Mancha M, Cabrera Ortega JD, Pont Martinez P, Saavedra Rodriguez JM, Toledo Pallares J. [National Action Plan for Prevention and Tobacco Control]. Rev Esp Salud Publica. 2003 Jul-Aug;77(4):441-73. No abstract available. Spanish.

Reference Type BACKGROUND
PMID: 12945131 (View on PubMed)

Banegas JR, Diez Ganan L, Gonzalez Enriquez J, Villar Alvarez F, Rodriguez-Artalejo F. [Recent decrease in smoking-attributable mortality in Spain]. Med Clin (Barc). 2005 May 28;124(20):769-71. doi: 10.1157/13075847. Spanish.

Reference Type BACKGROUND
PMID: 15927102 (View on PubMed)

Villalbi JR, Castillo A, Cleries M, Salto E, Sanchez E, Martinez R, Tresserras R, Vela E; Barcelona Group. Acute myocardial infarction hospitalization statistics: apparent decline accompanying an increase in smoke-free areas. Rev Esp Cardiol. 2009 Jul;62(7):812-5. doi: 10.1016/s1885-5857(09)72362-x. English, Spanish.

Reference Type BACKGROUND
PMID: 19709517 (View on PubMed)

Fernandez E, Fu M, Pascual JA, Lopez MJ, Perez-Rios M, Schiaffino A, Martinez-Sanchez JM, Ariza C, Salto E, Nebot M; Spanish Smoking Law Evaluation Group. Impact of the Spanish smoking law on exposure to second-hand smoke and respiratory health in hospitality workers: a cohort study. PLoS One. 2009;4(1):e4244. doi: 10.1371/journal.pone.0004244. Epub 2009 Jan 23.

Reference Type BACKGROUND
PMID: 19165321 (View on PubMed)

Martinez-Sanchez JM, Fernandez E, Fu M, Perez-Rios M, Lopez MJ, Ariza C, Pascual JA, Schiaffino A, Perez-Ortuno R, Salto E, Nebot M. Impact of the Spanish smoking law in smoker hospitality workers. Nicotine Tob Res. 2009 Sep;11(9):1099-106. doi: 10.1093/ntr/ntp107. Epub 2009 Jul 29.

Reference Type BACKGROUND
PMID: 19640834 (View on PubMed)

Silagy C. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD000165. doi: 10.1002/14651858.CD000165.

Reference Type BACKGROUND
PMID: 10796499 (View on PubMed)

Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.

Reference Type BACKGROUND
PMID: 18617085 (View on PubMed)

Sanz Pozo B, de Miguel Diez J, Camarelles Guillem F. [Non-pharmacological methods in tobacco dishabituation]. Rev Clin Esp. 2004 Jan;204(1):37-9. doi: 10.1157/13056793. No abstract available. Spanish.

Reference Type BACKGROUND
PMID: 14746762 (View on PubMed)

Kottke TE, Battista RN, DeFriese GH, Brekke ML. Attributes of successful smoking cessation interventions in medical practice. A meta-analysis of 39 controlled trials. JAMA. 1988 May 20;259(19):2883-9. doi: 10.1001/jama.259.19.2883.

Reference Type BACKGROUND
PMID: 3367456 (View on PubMed)

Camarelles Guillem F, Salvador Llivina T, Ramon Torell JM, Cordoba Garcia R, Jimenez Ruiz C, Lopez Garcia-Aranda V, Villalbi Hereter JR, Planchuelo Santos MA, Sanchez Monfort J, Lopez de Santiago A. [Consensus on health assistance for smoking control in Spain]. Rev Esp Salud Publica. 2009 Mar-Apr;83(2):175-200. doi: 10.1590/s1135-57272009000200004. Spanish.

Reference Type BACKGROUND
PMID: 19626247 (View on PubMed)

F. Marqués Molías, et al. Recomendaciones sobre el estilo de vida. Grupo de Educación para la Salud del PAPPS. actualizacion 2009. acceso (23/03/2011): http://www.papps.org/upload/file/08%20PAPPS%20ACTUALIZACION%202009.pdf

Reference Type BACKGROUND

Javier Mataix Sancho et al. Guia para el tratamiento del tabaquismo activo y pasivo. segunda edicion 2009. accesso (24/03/2011): http://www.papps.org/upload/file/publicaciones/Guia%20Tabaquismo2009.pdf.

Reference Type BACKGROUND

Martin Cantera C, Cordoba Garcia R, Jane Julio C, Nebot Adell M, Galan Herrera S, Aliaga M, Pujol Ribera E, Ballestin M. [Mid-term evaluation of a help program for smokers]. Med Clin (Barc). 1997 Nov 29;109(19):744-8. Spanish.

Reference Type BACKGROUND
PMID: 9470183 (View on PubMed)

Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.

Reference Type BACKGROUND
PMID: 6863699 (View on PubMed)

Prochaska JO, Velicer WF, DiClemente CC, Fava J. Measuring processes of change: applications to the cessation of smoking. J Consult Clin Psychol. 1988 Aug;56(4):520-8. doi: 10.1037//0022-006x.56.4.520. No abstract available.

Reference Type BACKGROUND
PMID: 3198809 (View on PubMed)

Bize R, Burnand B, Mueller Y, Rege Walther M, Cornuz J. Biomedical risk assessment as an aid for smoking cessation. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004705. doi: 10.1002/14651858.CD004705.pub3.

Reference Type BACKGROUND
PMID: 19370604 (View on PubMed)

Clotet J, Gomez-Arbones X, Ciria C, Albalad JM. [Spirometry is a good method for detecting and monitoring chronic obstructive pulmonary disease in high-risk smokers in primary health care]. Arch Bronconeumol. 2004 Apr;40(4):155-9. doi: 10.1016/s1579-2129(06)60207-3. Spanish.

Reference Type BACKGROUND
PMID: 15030729 (View on PubMed)

Czajkowska-Malinowska M, Nowinski A, Gorecka D, Zielinski J. [Effects of spirometric screening in the community on smoking cessation]. Pneumonol Alergol Pol. 2001;69(9-10):524-9. Polish.

Reference Type BACKGROUND
PMID: 11928658 (View on PubMed)

Risser NL, Belcher DW. Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. J Gen Intern Med. 1990 Jan-Feb;5(1):16-22. doi: 10.1007/BF02602303.

Reference Type BACKGROUND
PMID: 2405112 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BRISA II.EPOC-Tabaco

Identifier Type: -

Identifier Source: org_study_id