Contact information
Type
Scientific
Primary contact
Miss Joana Ripoll
ORCID ID
Contact details
C/Reina Esclaramunda,9
Palma de Mallorca
07003
Spain
jripoll@ibsalut.caib.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI09/90841
Study information
Scientific title
A randomised controlled trial on the efficacy of exhaled carbon monoxide measurement plus brief physician's advice for smoking cessation
Acronym
Study hypothesis
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
Ethics approval
The Ethics Committee on Human Research of the Balearic Islands approved on the 24th of September 2008 (ref: IB 985/08)
Study design
Parallel randomised controlled trial with blind evaluation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet
Condition
Smoking cessation
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Sustained abstinence (at 6 and 12 months) validated by urine cotinine test
Secondary outcome measures
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
Overall trial start date
15/10/2010
Overall trial end date
15/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Smokers ≥ 18 years attended for any reason
2. Smokers in contemplation or precontemplation phase
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
942 patients
Participant exclusion criteria
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
Recruitment start date
15/10/2010
Recruitment end date
15/10/2012
Locations
Countries of recruitment
Spain
Trial participating centre
C/Reina Esclaramunda,9
Palma de Mallorca
07003
Spain
Sponsor information
Organisation
Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Sponsor details
Research Unit
Mallorca Primary Care Management
C/Reina Esclaramunda,9
Palma de Mallorca
07003
Spain
+34 (0)971 175883
aleiva@ibsalut.caib.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22551017
Publication citations
-
Protocol
Ripoll J, Girauta H, Ramos M, Medina-Bombardó D, Pastor A, Alvarez-Ossorio C, Gorreto L, Esteva M, García E, Uréndez A, Buades A, Torres E, Clinical trial on the efficacy of exhaled carbon monoxide measurement in smoking cessation in primary health care., BMC Public Health, 2012, 12, 322, doi: 10.1186/1471-2458-12-322.