Effectiveness of co-oximetry and minimum advice for smoking cessation in kidney transplant recipients
| ISRCTN | ISRCTN16615772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16615772 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/06/2015
- Registration date
- 02/07/2015
- Last edited
- 17/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
In order to modify a problem behaviour, for example smoking, over-eating or drinking too much, a person has to be motivated to make that change. Many people are in denial of their problem behaviour and may not see their behaviour as problematic; these people are considered to be in the precontemplation stage. In contrast, some people are willing to admit that they may have a problem, are comtemplating changing their behaviour but are ambivalent about doing so. Here, we are looking at how successful measuring exhaled carbon monoxide (MO) along with brief advice for smoking cessation helps smoking kidney recipients to stop smoking, increase their motivation to stop smoking or reduce the number of cigarettes that they smoke per day. We will be comparing the results of this intervention for people at the contemplation stage compared with the precontemplation stage of change. We will also be looking at how well it works compared to when people are given brief advice alone.
Who can participate?
Smoking kidney transplant recipients who are prepared to give up smoking, are contemplating it or are in the precontemplation stage.
What does the study involve?
Participants are randomised into one of two groups. Those in group 1 are assigned as controls. Those in group 2 are assigned to the intervention group. All participants are given a brief advisory session about giving up smoking; this is individually tailored and provides information about the health risks of smoking and the main advantages of quitting the habit. Participants in the intervention group also have the oxygen carrying state of their haemoglobin (protein in red blood cells that carry oxygen) measured using a CO-oximeter; this detects the amount of carbon monoxide (CO) that the participant has in their body. All participants from both groups are followed up 3 months, 6 months and 9 months later. At each of these visits, the anti-smoking advice is repeated for the control group and anti-smoking advice plus CO-oximetry for the intervention group. How well the intervention performs is assessed at 3, 6, 9 and 12 months. This includes looking at how many participants have reduced the amount of cigarettes they smoke, or stop smoking altogether.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital Complex A Coruña (Spain)
When is the study starting and how long is it expected to run for?
December 2012 to December 2015
Who is funding the study?
Instituto de Salud (National Institute of Health) Carlos III (Spain)
Who is the main contact?
Dr Salvador Pita- Fernández
Contact information
Scientific
Complejo Hospitalario Universitario de A Coruña
Clinical epidemiology and biostatistics Unit
As Xubias de Arriba 84
A Coruña
15006
Spain
Study information
| Study design | Randomized controlled trial (open, with blinded evaluation) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of co-oximetry and minimum advice for smoking cessation in kidney transplant recipients: a randomized controlled trial |
| Study hypothesis | To compare, in smoking kidney transplant recipients in the contemplation or precontemplation stage of change, the effectiveness of the measurement of exhaled carbon monoxide (CO) plus brief advice for smoking cessation, compared with brief advice alone, with respect to: 1. Smoking cessation 2. Increased motivation to quit smoking 3. Reduction in the number of cigarettes smoked per day |
| Ethics approval(s) | Comité ético de investigación clínica de Galicia, ref: 2011/061 |
| Condition | Smoking in kidney transplant recipients |
| Intervention | Patients will be randomized to: 1. The control group (brief advice for smoking cessation) or 2. Intervention (brief advice + exhaled CO measurement) |
| Intervention type | Behavioural |
| Primary outcome measure | The effectiveness will be evaluated at 6 and 12 months by smoking cessation confirmed by nicotine test results. |
| Secondary outcome measures | Abandoned self-declared (by number of cigarettes smoked per day and changes in the dependency stage). |
| Overall study start date | 01/12/2012 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | n= 122 (alfa=95%, Power=80% Loss=10%.Difference to detect 12%) |
| Total final enrolment | 122 |
| Participant inclusion criteria | Smoking kidney transplant recipients, in preparation stage, precontemplation and contemplation stage of change, that give their consent to participate |
| Participant exclusion criteria | Patients with terminal illness or mental disability. |
| Recruitment start date | 01/12/2012 |
| Recruitment end date | 31/12/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
A Coruña
15006
Spain
Sponsor information
Hospital/treatment centre
As Xubias de Arriba 84
A Coruña
15006
Spain
"ROR" |
https://ror.org/044knj408 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/04/2016 | Yes | No | |
| Results article | 23/09/2020 | 17/08/2023 | Yes | No |
Editorial Notes
17/08/2023: Publication reference and total final enrolment added.
04/04/2016: Publication reference added.
