Condition category
Not Applicable
Date applied
16/06/2010
Date assigned
21/07/2010
Last edited
12/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes