Effectiveness of Spirometry as a Motivational Tool to Quit Smoking (ESPIMOAT)

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.

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; COPD
• Intervention / Treatment: Behavioral: Spirometry and a brief advice to quit smoking; Behavioral: Brief advice to quit smoking

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava 45
    • Vitoria-Gasteiz, Alava 45, Spain, 1006
      • Basque Health Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spirometry and a brief advice to quit smoking; Intervention group: The intervention consists of completing a questionnaire and undergo spirometry with bronchodilator test by a trained nurse. Later, the patients receives a brief advice to quit smoking and a report of the spirometry results by their family doctor.	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.
Active Comparator: Brief advice to quit smoking; Control group: Patients in the control group complete a questionnaire by a nurse and then receive a brief advice to quit smoking by their family doctor.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: Mª Isabel Irizar Aramburu, Osakidetza

Publications and helpful links

General Publications

• Irizar-Aramburu MI, Martinez-Eizaguirre JM, Pacheco-Bravo P, Diaz-Atienza M, Aguirre-Arratibel I, Pena-Pena MI, Alba-Latorre M, Galparsoro-Goikoetxea M. Effectiveness of spirometry as a motivational tool for smoking cessation: a clinical trial, the ESPIMOAT study. BMC Fam Pract. 2013 Dec 5;14:185. doi: 10.1186/1471-2296-14-185.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 27, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 1, 2013

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: COPD; smoking cessation; tobacco; screening; Spirometry
• Other Study ID Numbers: 2011111013; KRONIK11/071 - EJGV 2011111013 (Other Identifier: KRONIKGUNE - EUSKO JAURLARITZA/GOBIERNO VASCO)