Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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Telephone-based Motivational Interviewing Delivered by IBD ( Inflammatory Bowel Disease) Nurses for Smoking Cessation in Crohn's Disease: a Randomized Open-label Clinical Trial

Conditions
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Crohn Disease

Intervention / Treatment
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* Behavioral: Telephone-based motivational interviewing for smoking cessation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-based motivational interviewing<br>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<br>* 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.<br>|
| No Intervention: usual care<br>No intervention consisted of a single telephone contact one year after the star of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | We measure it at baseline and through study completion, 1 year after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | We measure it at baseline and through study completion, 1 year after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Smoking cessation, Tobacco, Smoking, Advanced practice nurse, Motivational intervention