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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mº Isabel Irizar Aramburu, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01821885
First received: March 27, 2013
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after been conducted the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after been conducted the intervention ] [ Designated as safety issue: No ]
    Evaluate the differences in smoking cessation rates between patients with COPD and those without.


Estimated Enrollment: 316
Study Start Date: April 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Basque Health Service

Additional 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
Study First Received: March 27, 2013
Last Updated: April 3, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Basque Health Service:
Spirometry
screening
smoking cessation
tobacco
COPD

ClinicalTrials.gov processed this record on November 20, 2014