Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

NCT01821885 | Completed

• 2 other identifiers: 2011111013KRONIK11/071 - EJGV 2011111013
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; COPD

Keywords

Spirometry; screening; smoking cessation; tobacco; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reduce the number of cigarettes among those who continue smoking

  12 months after been conducted the intervention

• Increase smoking abstinence rates in patients with COPD

  12 months after been conducted the intervention

Study Arms (2)

Spirometry and a brief advice to quit smoking

EXPERIMENTAL

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

Brief advice to quit smoking

ACTIVE COMPARATOR

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

Interventions

Spirometry and a brief advice to quit smoking BEHAVIORAL

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.

Spirometry and a brief advice to quit smoking

Brief advice to quit smoking BEHAVIORAL

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.

Brief advice to quit smoking

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Basque health service

Vitoria-Gasteiz, Alava 45, 1006, Spain

Location

Related Publications (1)

• 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.

  PMID: 24308728 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mª Isabel Irizar Aramburu

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: family doctor

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2015
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

ES (1)