Crohn Disease
Conditions
Keywords
Inflammatory Bowel Disease, Smoking cessation, Tobacco, Smoking, Advanced practice nurse, Motivational intervention
Brief summary
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.
Interventions
BEHAVIORALTelephone-based motivational interviewing for smoking cessation
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.
Sponsors
GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal
Department of Health, Generalitat de Catalunya
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smokers Crohn's disease patients * \>18 age
Exclusion criteria
* Smokers Crohn's disease patients who are receiving treatment of tobacco cessation at the time of inclusion * Do not have email
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from motivation to quit smoking after at one year in the control group and in the experimental group | We measure it at baseline and through study completion, 1 year after | 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 |
| Change from stages of changes to quit smoking after at one year in the control group and in the experimental group | We measure it at baseline and through study completion, 1 year after | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | We measure it at baseline and through study completion, 1 year after | Cosnes classification: current smokers \>7 cigarettes per week for at least 6 months, former smokers who had stopped smoking at least 6 months before. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The rate of patients who had received the 5 A intervention referred to the smoking cessation unit. | We measure it at baseline and through study completion, 1 year after | Control visits in Hospital smoking cessation Unit |
| The rate of patients who had received the 5 R intervention referred to the smoking cessation unit. | We measure it at baseline and through study completion, 1 year after | Control visits in Hospital smoking cessation Unit |
Outcome results
None listed