Effectiveness of Regular Reporting of Spirometric Results on Smoking Quit Rate. (ESPIROTAB)

February 13, 2011 updated by: Jordi Gol i Gurina Foundation

Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.

The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.

Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.

Expected outcome: increase of smoking cessation rate .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Design: Intervention study with two randomized arms in 5 primary care centers of two health areas.

Study population: 466 smokers over the age of 18 consulting their primary care physician for any reason and who do not fulfil the exclusion criteria.

Measurements and interventions: The study data will be collected using a structured questionnaire and data collection sheets specifically designed for the study The structured questionnaire will include the following data: sociodemographics, clinical history, smoking habit, respiratory symptomatology, smoking dependence test and smoking cessation motivation test.

The data collection sheets will include information related to the spirometric results, peak expiratory flow rate and the carbon monoxide test when performed.

On visit 0, the primary care physician will give a brief structured smoking cessation advice to all patients combined with a detailed and structured discussion of the spirometric results. After this visit the patients will be randomised in two arms (control and intervention groups).

Randomisation will be performed using a computer programme.

Randomisation will be carried out by the Coordinating Centre.

Both groups will be followed up by telephone at three (visit 1) and six months (visit 2) and at one-year (visit 3) and two-year(visit 4).

During the follow up visits brief structured smoking cessation advice will be reinforced in the control group but the spirometric results will not be discussed. In the intervention group brief structured smoking cessation advice will be reinforced with a detailed structured reminder discussion of the results obtained from the spyrometry of visit 0.

Follow up visits 1 and 2 will be undertaken by telephone and the patients will be asked about their smoking habit and will be given a brief questionnaire.

One month before visits 3 and 4 both groups will undergo the same series of tests performed prior to visit 0 with the exception of the peak expiratory flow rate. Spirometry will be done only in the intervention group.

On visits 3 and 4, the same intervention will be done. On both visits 3 and 4 all the participants who report smoking withdrawal will undergo the carbon monoxide test.

Study Type

Interventional

Enrollment (Actual)

466

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Jordi Gol i Gurina Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult smoker population over the age of 18 years attended by their primary care physician for any reason and who do not fulfil exclusion criteria

Exclusion Criteria:

  • Previous diagnosis of COPD by spirometry.
  • Patients contraindicated to undertake spirometry.
  • Patients without a telephone.
  • Patients with communication difficulties: cognitive and/or sensorial deterioration, language.
  • Patients with severe disease of poor prognosis (life expectancy of less than one year).
  • Patients with another respiratory disease: asthma, COPD, neoplasm of the respiratory tract, pulmonary thromboembolism, pulmonary tuberculosis, interstitial diseases.
  • Patients who do not give written informed consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spirometry and lifestyle counseling
Intervention group: The intervention is to give brief structured smoking cessation advice combined with a detailed and structured discussion of the spirometric results.
Behavioral: Lifestyle counseling and spirometry
The patients of the intervention group will be given a brief structured smoking cessation advice by their primary care physician combined with a detailed and structured discussion of the spirometry results.
No Intervention: Lifestyle counseling
No intervention group: the patients of the control group will receive a brief structured smoking cessation advice.
Behavioral: Smoking cessation advice
Brief smoking cessation advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking abstinence: self reported abstinence (12 or more months smoking free.
Time Frame: 24 months after last recruitment
Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No
24 months after last recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordi Gol i Gurina Foundation

Collaborators

Catalan Institute of Health
Research Support Unit Metropolitana Nord, Barcelona, Spain

Investigators

  • Principal Investigator: Mar Rodriguez, Institut Català de la Salut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

February 13, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2011

Last Update Submitted That Met QC Criteria

February 13, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P10/40.
  • Jordi Gol i Gurina Foundation (Other Identifier: 4R07/040)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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