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CompletedNCT03377738Updated Dec 19, 2017

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

An interventional study of spirometry in Tobacco Cessation, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Completed at 1 site in Spain. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.

Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tobacco Cessation

Keywords

  • Spirometry
  • Primary care
  • Smoking Cessations
03

In context

Tobacco Use Cessation

276 studies on the registry are indexed under Tobacco Use Cessation; 45 are open to participants now.

This study's enrollment of 90 is below the median of 226 across 256 interventional studies indexed under Tobacco Use Cessation.

Browse Tobacco Use Cessation studies →

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 43 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testspirometry

    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.

06

What researchers measure

Primary outcomes

  1. - Number of cessations of the tobacco habit (%)

    Time frame: 2-3 weeks, 3 month and 6 months

  2. - Cessation phase of the tobacco habit (%)

    Time frame: 2-3 weeks, 3 month and 6 months

Secondary outcomes

  1. Score on the Richmond test for assessing motivation to quit smoking.

    Time frame: 2-3 weeks, 3 month and 6 months

  2. Fagerström test score to assess dependency.

    Time frame: 2-3 weeks, 3 month and 6 months

  3. Carbon monoxide levels (CO) (co-oximetry).

    Time frame: 2-3 weeks, 3 month and 6 months

  4. Anthropometric variables: weight, size and body mass index Exposure to tobacco: nº packets/day.

    Time frame: 2-3 weeks, 3 month and 6 months

07

Study locations

1 site
  • Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
    Murcia, Region De Murcia 30003, Spain
08

References and documents

Publications

  • Instituto Nacional de Estadística INE. Encuesta Nacional de Salud 2006.
  • 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. PubMed 17692241 ↗
  • 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. PubMed 12945131 ↗
  • 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. PubMed 15927102 ↗
  • 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. PubMed 19709517 ↗
  • 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. PubMed 19165321 ↗
  • 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. PubMed 19640834 ↗
  • Silagy C. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD000165. doi: 10.1002/14651858.CD000165. PubMed 10796499 ↗
  • 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. PubMed 18617085 ↗
  • 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. PubMed 14746762 ↗
  • 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. PubMed 3367456 ↗
  • 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. PubMed 19626247 ↗
  • 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. PubMed 9470183 ↗
  • 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. PubMed 6863699 ↗
  • 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. PubMed 3198809 ↗
  • 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. PubMed 19370604 ↗
  • 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. PubMed 15030729 ↗
  • 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. PubMed 11928658 ↗
  • 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. PubMed 2405112 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2011 to primary completion in Dec 2011, 7 months.

Of 115 non-industry interventional studies with no phase under Tobacco Use Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 7 months is below that.

Counting every sponsor, half of 116 studies reached it within 24 months; a quarter within 15 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2011
First posted
Dec 19, 2017
StartActual
May 2011
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Dec 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03377738
Lead sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
MurciaSalud, Public Health Service, Murcia, AstraZeneca
Responsible party
Sponsor
First posted
Dec 19, 2017
Start date
May 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Dec 19, 2017

Study contacts

A Lopez-santiago, MD
principal investigator · Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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