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Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care. (RESET-ESPITAP2)

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ClinicalTrials.gov Identifier: NCT02153047
Recruitment Status : Unknown
Verified May 2014 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Catalan Institute of Health
Primary Care Area Tarragona-Reus
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:

There is controversy about the effectiveness of interventions based on spirometry for smoking cessation.

The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care.

This study, is the second half of what was began with ESPITAP study


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Spirometry Not Applicable

Detailed Description:

Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not.

Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption.

Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be <10ppm abstinence will be verified by determination of urinary cotinine.

Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the "intent to treat", the unit of analysis will be the smoker.

Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.
Study Start Date : November 2011
Actual Primary Completion Date : November 2013
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spirometry
Will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical)
Behavioral: Spirometry
Will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical)

No Intervention: Brief smoking cessation advice
Will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine).



Primary Outcome Measures :
  1. Cessation of tobacco consumption at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Smoking reduction: self reported reduction [ Time Frame: 12 Months ]
    Smoking reduction by self reported reduction



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active smokers (consumption>10 packs/year)

Exclusion Criteria:

  • Active respiratory disease
  • Practice of an espirometry on 12 months before
  • Suffering of any chronic or terminal disorder
  • Counterindication to undertake spirometry or that may hinder the performance of the spirometry test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153047


Locations
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Spain
Jordi Gol i Gurina Foundation
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Catalan Institute of Health
Primary Care Area Tarragona-Reus
Investigators
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Principal Investigator: Antoni Santigosa-Ayala, MD Catalan Institute of Health
Study Director: Francisco Martín-Luján, PhD Catalan Institute of Health
Study Chair: Rosa Sola-Alberich, MD Catalan Institute of Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02153047     History of Changes
Other Study ID Numbers: PI11/01962
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by Jordi Gol i Gurina Foundation:
Smoking cessation
Spirometry
Primary health care