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 |
| Secondary identifying numbers | PI09/90841 |
- 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
Scientific
C/Reina Esclaramunda,9
Palma de Mallorca
07003
Spain
| jripoll@ibsalut.caib.es |
Study information
| Study design | Parallel randomised controlled trial with blind evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient 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 | 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 study start date | 15/10/2010 |
| Completion date | 15/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 942 patients |
| 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
07003
Spain
Sponsor information
Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Government
Government
Research Unit
Mallorca Primary Care Management
C/Reina Esclaramunda,9
Palma de Mallorca
07003
Spain
| Phone | +34 (0)971 175883 |
|---|---|
| aleiva@ibsalut.caib.es | |
"ROR" |
https://ror.org/00d9y8h06 |
Funders
Funder type
Government
Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
