An interventional study of Telephone-based motivational interviewing for smoking cessation in Crohn Disease, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Supportive care
Quitting smoking unequivocally improves the course of Crohn's disease (EC), and therefore, it should be one of the main therapeutic targets in the treatment of this disease. The goal of the study was to know the effectiveness of motivational intervention 5 R for smoking cessation in patients with Crohn's disease performed by telephone by nursing, in relation to those who did not receive such intervention.
For this purpose, a controlled, randomized, parallel and open clinical trial was designed. The subjects were patients with Crohn's disease that were actively smoking EC. They were all >18 years old and they had internet access and e-mail. Those who were already in a process of smoking cessation were excluded from the study. Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 144 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 275 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year, performed by IBD nurse
Behavioral: Telephone-based motivational interviewing for smoking cessation
No intervention consisted of a single telephone contact one year after the star of the study
The motivational brief intervention is known by the acronym 5 R and lasts about 5-10 minutes. It is an approach based on the principles of motivational interviewing and develops the intervention in five short steps: * Relevance. Help patients identify why personal reasons may be relevant to quitting smoking. * Risks. Help identify what negative consequences tobacco use has. * Rewards. Help identify potential benefits of quitting smoking. * Resistors. Help patients identify barriers to smoking cessation, which can often include fear of withdrawal symptoms, failure, wainweight, face social situations, etc. * Repeat. Repeat the intervention at 3 months if you do not advance at the stage of change.
Change from motivation to quit smoking after at one year in the control group and in the experimental group
Test de Richmond: to measure the motivation to quit smoking. It consists of 4 questions, scores from 0 to 10, highest score, highest motivation. It provides three categories, low motivation \<4 points, medium motivation 5-6 and high motivation ≥7
Time frame: We measure it at baseline and through study completion, 1 year after
Change from stages of changes to quit smoking after at one year in the control group and in the experimental group
Stages of changes form Prochaska / DiClemente. Transtheoretical model of change consists of 4 mutually exclusive questions and has a legend where it classifies patients according to the state of the wheel of change in which they are: pre-contemplation, preparation, action, maintenance, consolidation and relapse.
Time frame: We measure it at baseline and through study completion, 1 year after
Number of patients with Crohn's disease who quit smoking at the end of the study in the control group and in the experimental group.
Cosnes classification: current smokers \>7 cigarettes per week for at least 6 months, former smokers who had stopped smoking at least 6 months before.
Time frame: We measure it at baseline and through study completion, 1 year after
The rate of patients who had received the 5 A intervention referred to the smoking cessation unit.
Control visits in Hospital smoking cessation Unit
Time frame: We measure it at baseline and through study completion, 1 year after
The rate of patients who had received the 5 R intervention referred to the smoking cessation unit.
Control visits in Hospital smoking cessation Unit
Time frame: We measure it at baseline and through study completion, 1 year after
No study locations are listed for this record.
Plan to share: No
Ran from Nov 2015 to primary completion in May 2017, 18 months.
Of 280 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 67. This study's 18 months is below that.
Counting every sponsor, half of 289 studies reached it within 45 months; a quarter within 22 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitari Vall d'Hebron Research Institute →