Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

COPD Clinical Trial

— ESPIMOAT  

Official title:

Effectiveness of Spirometry and the Report of Spirometric Test Results by a Primary Care Physician on Smoking Cessation Rate in Adult Smokers: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821885
• Other study ID #: 2011111013
• Secondary ID: KRONIK11/071 - E
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: January 26, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: January 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Active smokers over 40 years and more than 10 pack-years

Exclusion Criteria:

• Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern.

• Patients with limitations in performing spirometry

• Age greater than 80 years

• Institutionalized patients

• Patients with a life expectancy less than 1 year

• Spirometry in the past 2 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• COPD
• Smoking Cessation

Intervention

Behavioral:
• Spirometry and a brief advice to quit smoking
During a year, recruitment for active smoker patients was done by doctors in primary care medical offices. In the intervention group, after been randomized, one trained nurse completed the questionnaires and did the spirometry with bronchodilator test and set a date with its family doctor who did a minimal smoking cessation counselling intervention and informed the patients about the spirometry results according to established protocol.
• Brief advice to quit smoking
During a year, recruitment for active smokers patients occurred through doctors in primary care medical offices. After be randomized, in de control group, a nurse complete the questionnaires. Below, patients go to the family doctor who will do a minimal smoking cessation counselling intervention.

Locations

Country	Name	City	State
Spain	Basque health service	Vitoria-Gasteiz	Alava 45

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary measure of results will be the differences in smoking cessation rates between intervention and control groups	In all patients who report smoking withdrawal, smoking cessation will be confirmed by air carbon monoxide concentration.	12 months after been conducted the intervention	No
Secondary	Reduce the number of cigarettes among those who continue smoking	One secondary outcome will be to reduce the number of cigarettes. In all patients who continue smoking will be recorded the number of cigarettes smoked per day currently	12 months after been conducted the intervention	No
Secondary	Increase smoking abstinence rates in patients with COPD	Evaluate the differences in smoking cessation rates between patients with COPD and those without.	12 months after been conducted the intervention	No