Condition category
Mental and Behavioural Disorders
Date applied
05/06/2015
Date assigned
02/07/2015
Last edited
04/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Salvador Pita-Fernández

ORCID ID

Contact details

Complejo Hospitalario Universitario de A Coruña
Clinical epidemiology and biostatistics Unit
As Xubias de Arriba 84
A Coruña
15006
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of co-oximetry and minimum advice for smoking cessation in kidney transplant recipients: a randomized controlled trial

Acronym

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

Comité ético de investigación clínica de Galicia, ref: 2011/061

Study design

Randomized controlled trial (open, with blinded evaluation)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2012

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Smoking kidney transplant recipients, in preparation stage, precontemplation and contemplation stage of change, that give their consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

n= 122 (alfa=95%, Power=80% Loss=10%.Difference to detect 12%)

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

Trial participating centre

University Hospital Complex A Coruña (Sergas Complejo Hospitalario Universitario de A Coruña)
As Xubias de Arriba 84
A Coruña
15006
Spain

Sponsor information

Organisation

Complejo Hsopitalario Universitario de A Coruña

Sponsor details

As Xubias de Arriba 84
A Coruña
15006
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Instituto de Salud Carlos III

Alternative name(s)

Institute of Health Carlos III, Carlos III Health Institute, ISCIII

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27036112

Publication citations

Additional files

Editorial Notes

04/04/2016: Publication reference added.