Clinical trial NCT03377738: Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care
Official title: Randomized Clinical Trial About the Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Cessation
Keywords: Spirometry
Primary care
Smoking Cessations
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
Collaborators: name: MurciaSalud
name: Public Health Service, Murcia
name: AstraZeneca
First posted: 2017-12-19
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: - Number of cessations of the tobacco habit (%)
timeFrame: 2-3 weeks, 3 month and 6 months
measure: - Cessation phase of the tobacco habit (%)
timeFrame: 2-3 weeks, 3 month and 6 months
Secondary outcomes:
measure: Score on the Richmond test for assessing motivation to quit smoking.
timeFrame: 2-3 weeks, 3 month and 6 months
measure: Fagerström test score to assess dependency.
timeFrame: 2-3 weeks, 3 month and 6 months
measure: Carbon monoxide levels (CO) (co-oximetry).
timeFrame: 2-3 weeks, 3 month and 6 months
measure: Anthropometric variables: weight, size and body mass index Exposure to tobacco: nº packets/day.
timeFrame: 2-3 weeks, 3 month and 6 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
state: Region De Murcia
Study officials:
affiliation: Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
name: A Lopez-santiago, MD
role: PRINCIPAL_INVESTIGATOR
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