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

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ClinicalTrials.gov Identifier: NCT01821885
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):

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
Smoking Cessation COPD Behavioral: Spirometry and a brief advice to quit smoking Behavioral: Brief advice to quit smoking

Study Design

Study Type : Interventional  (Clinical Trial)
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 : April 2012
Primary Completion Date : December 2013
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. The primary measure of results will be the differences in smoking cessation rates between intervention and control groups [ Time Frame: 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 :
  1. Reduce the number of cigarettes among those who continue smoking [ Time Frame: 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

  2. Increase smoking abstinence rates in patients with COPD [ Time Frame: 12 months after been conducted the intervention ]
    Evaluate the differences in smoking cessation rates between patients with COPD and those without.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821885


Locations
Spain
Basque health service
Vitoria-Gasteiz, Alava 45, Spain, 1006
Sponsors and Collaborators
Basque Health Service
Investigators
Principal Investigator: Mª Isabel Irizar Aramburu Osakidetza
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mº Isabel Irizar Aramburu, family doctor, Basque Health Service
ClinicalTrials.gov Identifier: NCT01821885     History of Changes
Other Study ID Numbers: 2011111013
KRONIK11/071 - EJGV 2011111013 ( Other Identifier: KRONIKGUNE - EUSKO JAURLARITZA/GOBIERNO VASCO )
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Mº Isabel Irizar Aramburu, Basque Health Service:
Spirometry
screening
smoking cessation
tobacco
COPD