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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Jordi Gol i Gurina Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Catalan Health Institute
Research Support Unit Metropolitana Nord, Barcelona, Spain
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01296295
First received: July 30, 2010
Last updated: February 13, 2011
Last verified: February 2011
  Purpose

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 .


Condition Intervention
Smoking Cessation
COPD
Behavioral: Lifestyle counseling and spirometry
Behavioral: Smoking cessation advice

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 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.

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Smoking abstinence: self reported abstinence (12 or more months smoking free. [ Time Frame: 24 months after last recruitment ] [ Designated as safety issue: No ]
    Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No


Enrollment: 466
Study Start Date: January 2005
Estimated Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01296295

Locations
Spain
Jordi Gol i Gurina Foundation
Barcelona, Spain
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Catalan Health Institute
Research Support Unit Metropolitana Nord, Barcelona, Spain
Investigators
Principal Investigator: Mar Rodriguez Institut Catalá de la Salut
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria del Mar Rodriguez Alvarez, Catalan Health Institute
ClinicalTrials.gov Identifier: NCT01296295     History of Changes
Other Study ID Numbers: P10/40., Jordi Gol i Gurina Foundation
Study First Received: July 30, 2010
Last Updated: February 13, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Jordi Gol i Gurina Foundation:
smoking cessation advice
spirometry
primary health care

ClinicalTrials.gov processed this record on August 01, 2014