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

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Cessation
• Intervention / Treatment: Diagnostic test: spirometry

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Region De Murcia
    • Murcia, Region De Murcia, Spain, 30003
      • Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: anti-smoking therapy; All patients will be given only an intervention for tobacco cessation which will depend on the individual's cessation phase
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- Number of cessations of the tobacco habit (%)	2-3 weeks, 3 month and 6 months
- Cessation phase of the tobacco habit (%)	2-3 weeks, 3 month and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Score on the Richmond test for assessing motivation to quit smoking.	2-3 weeks, 3 month and 6 months
Fagerström test score to assess dependency.	2-3 weeks, 3 month and 6 months
Carbon monoxide levels (CO) (co-oximetry).	2-3 weeks, 3 month and 6 months
Anthropometric variables: weight, size and body mass index Exposure to tobacco: nº packets/day.	2-3 weeks, 3 month and 6 months

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Collaborators: AstraZeneca; MurciaSalud; Public Health Service, Murcia
• Investigators: Principal Investigator: A Lopez-santiago, MD, Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

Publications and helpful links

General Publications

• 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.
• 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.
• Instituto Nacional de Estadística INE. Encuesta Nacional de Salud 2006.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Silagy C. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD000165. doi: 10.1002/14651858.CD000165.
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• MeSH
• MeSH
• MeSH

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Primary care; Spirometry; Smoking Cessations
• Other Study ID Numbers: BRISA II.EPOC-Tabaco

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED