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ISRCTN
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ISRCTN67499921
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ClinicalTrials.gov identifier
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Public title
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Clinical trial on the efficacy of exhaled carbon monoxide measurement plus brief physician's advice for smoking cessation
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Scientific title
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A randomised controlled trial on the efficacy of exhaled carbon monoxide measurement plus brief physician's advice for smoking cessation
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Acronym
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N/A
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Serial number at source
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PI09/90841
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Study hypothesis
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Smoking is the leading cause of preventable death in industrialized countries. It has long been known that the effects of tobacco on health are multiple. The tobacco causes or encourages the development of different cancers, is the major cardiovascular risk factor, the most important known cause of chronic obstructive pulmonary disease and a risk factor for many health problems. Despite this knowledge, the prevalence of smoking in our country remains high. According to the National Health Survey of 2006 in the adult population, 31.56% men and 21.51% of women are daily smokers. Of these, 79% men and 70% of women smoke 10 or more cigarettes daily.
Hypotheses:
1. The implementation of exhaled CO2 monitoring by cooximetry for smokers in precontemplative or contemplative phase of quitting, improves the quit rate at 12 months by 5% more than brief physician's advice alone which achieves minimum quit rates of 5-7%
2. The implementation of exhaled CO2 monitoring by cooximetry for smokers in precontemplative or contemplative phase of quitting, reduces cigarette consumption at 12 months more than brief physician's advice alone
3. The implementation of exhaled CO2 monitoring by cooximetry for smokers in precontemplative or contemplative phase of quitting, increases the motivation to quit smoking at 12 months more than brief physician's advice alone
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Lay summary
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Ethics approval
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The Ethics Committee on Human Research of the Balearic Islands approved on the 24th of September 2008 (ref: IB 985/08)
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Study design
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Parallel randomised controlled trial with blind evaluation
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Smoking cessation
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Participants - inclusion criteria
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1. Smokers ≥ 18 years attended for any reason
2. Smokers in contemplation or precontemplation phase
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Participants - exclusion criteria
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1. Smokers in preparation phase of quitting
2. Patients with terminal illness or in a state of health that prevents understanding of study aims and signed informed consent
3. Pregnant and/or breast-feeding women
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Anticipated start date
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15/10/2010
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Anticipated end date
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15/10/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet
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Target number of participants
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942 patients
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Interventions
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Patients will be randomised to either
1. Control Group (CG): Brief face-to-face anti-smoking advice from the physician during patient consultation
2. Intervention Group (IG): Brief advice plus exhaled CO measure
There will be a follow-up evaluation at 6 months of inclusion and at 12 months.
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Primary outcome measure(s)
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Sustained abstinence (at 6 and 12 months) validated by urine cotinine test
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Secondary outcome measure(s)
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1. Prevalence of smoking cessation, self reported and confirmed by both cotinine test
2. Cigarettes reduction
3. Variation in phase of the abandonment of smoking
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Sources of funding
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Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
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Trial website
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Publications
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Contact name
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Miss
Joana
Ripoll
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Address
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C/Reina Esclaramunda,9
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City/town
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Palma de Mallorca
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Zip/Postcode
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07003
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Country
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Spain
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Email
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jripoll@ibsalut.caib.es
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Sponsor
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Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
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Address
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Research Unit
Mallorca Primary Care Management
C/Reina Esclaramunda,9
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City/town
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Palma de Mallorca
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Zip/Postcode
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07003
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Country
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Spain
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Tel
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+34 (0)971 175883
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Fax
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+34 (0)971 175888
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Email
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aleiva@ibsalut.caib.es
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Date applied
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16/06/2010
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Last edited
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21/07/2010
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Date ISRCTN assigned
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21/07/2010
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