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Completed

NCT Number: NCT01821885

Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

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.

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Key information

Conditions

Smoking Cessation Behavior COPD Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basque health service

Vitoria-Gasteiz, Alava 45, 1006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study 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.

Acronym: ESPIMOAT

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Apr 1, 2013
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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