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

Tobacco Cessation Clinical Trial

Official title:

Randomized Clinical Trial About the Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377738
• Other study ID #: BRISA II.EPOC-Tabaco
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: December 14, 2017
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Spain	Fundación para la Formación e Investigación Sanitarias de la Región de Murcia	Murcia	Region De Murcia

Sponsors (4)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	AstraZeneca, Consejeria de sanidad.Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion., MurciaSalud

Country where clinical trial is conducted

Spain, 

References & Publications (21)

Banegas JR, Díez Gañán L, González Enríquez J, Villar Alvarez F, Rodríguez-Artalejo F. [Recent decrease in smoking-attributable mortality in Spain]. Med Clin (Barc). 2005 May 28;124(20):769-71. Spanish. — View Citation

Bize R, Burnand B, Mueller Y, Rège 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. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD004705. — View Citation

Camarelles Guillem F, Salvador Llivina T, Ramón Torell JM, Córdoba García R, Jiménez Ruiz C, López García-Aranda V, Villalbí Hereter JR, Planchuelo Santos MA, Sánchez Monfort J, López de Santiago A. [Consensus on health assistance for smoking control in Spain]. Rev Esp Salud Publica. 2009 Mar-Apr;83(2):175-200. Spanish. — View Citation

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. Review. — View Citation

Clotet J, Gómez-Arbonés 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. Spanish. — View Citation

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

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

Fernández E, Fu M, Pascual JA, López MJ, Pérez-Ríos M, Schiaffino A, Martínez-Sánchez JM, Ariza C, Saltó 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. — View Citation

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

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.

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. — View Citation

Martín Cantera C, Córdoba García R, Jane Julio C, Nebot Adell M, Galán Herrera S, Aliaga M, Pujol Ribera E, Ballestín M. [Mid-term evaluation of a help program for smokers]. Med Clin (Barc). 1997 Nov 29;109(19):744-8. Spanish. — View Citation

Martínez-Sánchez JM, Fernández E, Fu M, Pérez-Ríos M, López MJ, Ariza C, Pascual JA, Schiaffino A, Pérez-Ortuño R, Saltó 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ruiz CA, Pinedo AR, Miranda JA, Bermúdez 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. Spanish. — View Citation

Saiz Martínez-Acitores I, Rubio Colavida J, Espiga López I, Alonso de la Iglesia B, Blanco Aguilar J, Cortés Mancha M, Cabrera Ortega JD, Pont Martínez P, Saavedra Rodríguez JM, Toledo Pallarés J. [National Action Plan for Prevention and Tobacco Control]. Rev Esp Salud Publica. 2003 Jul-Aug;77(4):441-73. Spanish. — View Citation

Sanz Pozo B, de Miguel Díez J, Camarelles Guillem F. [Non-pharmacological methods in tobacco dishabituation]. Rev Clin Esp. 2004 Jan;204(1):37-9. Spanish. — View Citation

Silagy C. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD000165. Review. Update in: Cochrane Database Syst Rev. 2001;(2):CD000165. — View Citation

Villalbí JR, Castillo A, Cleries M, Saltó E, Sánchez E, Martínez 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. English, Spanish. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Number of cessations of the tobacco habit (%)		2-3 weeks, 3 month and 6 months
Primary	- Cessation phase of the tobacco habit (%)		2-3 weeks, 3 month and 6 months
Secondary	Score on the Richmond test for assessing motivation to quit smoking.		2-3 weeks, 3 month and 6 months
Secondary	Fagerström test score to assess dependency.		2-3 weeks, 3 month and 6 months
Secondary	Carbon monoxide levels (CO) (co-oximetry).		2-3 weeks, 3 month and 6 months
Secondary	Anthropometric variables: weight, size and body mass index Exposure to tobacco: nº packets/day.		2-3 weeks, 3 month and 6 months

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