Clinical trial on the efficacy of exhaled carbon monoxide measurement plus brief physician's advice for smoking cessation

ISRCTN	ISRCTN67499921
DOI	https://doi.org/10.1186/ISRCTN67499921
Protocol serial number	PI09/90841
Sponsor	Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Funder	Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)

Submission date: 16/06/2010
Registration date: 21/07/2010
Last edited: 12/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Joana Ripoll
Scientific

C/Reina Esclaramunda,9
Palma de Mallorca
07003
Spain

Email	jripoll@ibsalut.caib.es

Study information

Primary study design	Interventional
Study design	Parallel randomised controlled trial with blind evaluation
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial on the efficacy of exhaled carbon monoxide measurement plus brief physician's advice for smoking cessation
Study objectives	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(s)	The Ethics Committee on Human Research of the Balearic Islands approved on the 24th of September 2008 (ref: IB 985/08)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Sustained abstinence (at 6 and 12 months) validated by urine cotinine test
Key secondary outcome measure(s)	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
Completion date	15/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	942
Key inclusion criteria	1. Smokers ≥ 18 years attended for any reason 2. Smokers in contemplation or precontemplation phase
Key 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
Date of first enrolment	15/10/2010
Date of final enrolment	15/10/2012

Locations

Countries of recruitment

Spain

Study participating centre

C/Reina Esclaramunda,9

Palma de Mallorca
07003
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	04/07/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes