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Clinical Trials/NCT03377738
NCT03377738CompletedNot Applicable

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

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia2 sites in 1 country90 target enrollmentStarted: May 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
- Cessation phase of the tobacco habit (%)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • 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.

Outcomes

Primary Outcomes

- Cessation phase of the tobacco habit (%)

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

- Number of cessations of the tobacco habit (%)

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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