NCT03377738

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6.1 years until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

June 22, 2011

Last Update Submit

December 14, 2017

Conditions

Keywords

SpirometryPrimary careSmoking Cessations

Outcome Measures

Primary Outcomes (2)

  • - 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 Outcomes (4)

  • 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

Study Arms (2)

anti-smoking therapy

NO INTERVENTION

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

anti-smoking therapy + spirometry

EXPERIMENTAL

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

spirometryDIAGNOSTIC_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.

anti-smoking therapy + spirometry

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Murcia, Murcia, 30003, Spain

Location

Related Publications (21)

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

    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.

    PMID: 17692241BACKGROUND
  • 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.

    PMID: 12945131BACKGROUND
  • 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.

    PMID: 15927102BACKGROUND
  • 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.

    PMID: 19709517BACKGROUND
  • 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.

    PMID: 19165321BACKGROUND
  • 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.

    PMID: 19640834BACKGROUND
  • Silagy C. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD000165. doi: 10.1002/14651858.CD000165.

    PMID: 10796499BACKGROUND
  • 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.

    PMID: 18617085BACKGROUND
  • 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.

    PMID: 14746762BACKGROUND
  • 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.

    PMID: 3367456BACKGROUND
  • 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.

    PMID: 19626247BACKGROUND
  • 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

    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.

    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.

    PMID: 9470183BACKGROUND
  • 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.

    PMID: 6863699BACKGROUND
  • 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.

    PMID: 3198809BACKGROUND
  • 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.

    PMID: 19370604BACKGROUND
  • 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.

    PMID: 15030729BACKGROUND
  • 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.

    PMID: 11928658BACKGROUND
  • 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.

    PMID: 2405112BACKGROUND

Related Links

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • A Lopez-santiago, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2011

First Posted

December 19, 2017

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations