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

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ClinicalTrials.gov Identifier: NCT03377738
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
MurciaSalud
Public Health Service, Murcia
AstraZeneca
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Condition or disease Intervention/treatment Phase
Tobacco Cessation Diagnostic Test: spirometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Clinical Trial About the Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care
Actual Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377738


Locations
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Spain
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Murcia, Region De Murcia, Spain, 30003
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
MurciaSalud
Public Health Service, Murcia
AstraZeneca
Investigators
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Principal Investigator: A Lopez-santiago, MD Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
Additional Information:
MeSH  This link exits the ClinicalTrials.gov site
MeSH  This link exits the ClinicalTrials.gov site
MeSH  This link exits the ClinicalTrials.gov site

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

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Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT03377738    
Other Study ID Numbers: BRISA II.EPOC-Tabaco
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Spirometry
Primary care
Smoking Cessations