ESPIMOAT: Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

Sponsor

Basque Health Service (Other)

Overall Status

Completed

CT.gov ID

NCT01821885

Collaborator

(none)

335

Enrollment

Location

Arms

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation COPD	Behavioral: Spirometry and a brief advice to quit smoking Behavioral: Brief advice to quit smoking	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

335 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The primary measure of results will be the differences in smoking cessation rates between intervention and control groups [12 months after been conducted the intervention]
In all patients who report smoking withdrawal, smoking cessation will be confirmed by air carbon monoxide concentration.

Secondary Outcome Measures

Reduce the number of cigarettes among those who continue smoking [12 months after been conducted the intervention]
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
Increase smoking abstinence rates in patients with COPD [12 months after been conducted the intervention]
Evaluate the differences in smoking cessation rates between patients with COPD and those without.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Basque health service	Vitoria-Gasteiz	Alava 45	Spain	1006

Sponsors and Collaborators

Basque Health Service

Investigators

Principal Investigator: Mª Isabel Irizar Aramburu, Osakidetza

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mº Isabel Irizar Aramburu, family doctor, Basque Health Service

ClinicalTrials.gov Identifier:

NCT01821885

Other Study ID Numbers:

2011111013
KRONIK11/071 - EJGV 2011111013

First Posted:

Apr 1, 2013

Last Update Posted:

Jan 27, 2015

Last Verified:

Jan 1, 2015

Keywords provided by Mº Isabel Irizar Aramburu, family doctor, Basque Health Service

Study Results

No Results Posted as of Jan 27, 2015