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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225403
• Other study ID #: PR(AG)275/2013
• Status: Completed
• Phase: N/A
• Start date: November 6, 2015
• Est. completion date: May 8, 2017

Study information

• Verified date: January 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 8, 2017
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Behavioral:
• Telephone-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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Department of Health, Generalitat de Catalunya, GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal

References & Publications (6)

Cosnes J, Beaugerie L, Carbonnel F, Gendre JP. Smoking cessation and the course of Crohn's disease: an intervention study. Gastroenterology. 2001 Apr;120(5):1093-9. — View Citation

Cosnes J. Smoking and Diet: Impact on Disease Course? Dig Dis. 2016;34(1-2):72-7. doi: 10.1159/000442930. Epub 2016 Mar 16. Review. — View Citation

Kaplan GG. Smoking Cessation for Crohn's Disease: Clearing the Haze. Am J Gastroenterol. 2016 Mar;111(3):420-2. doi: 10.1038/ajg.2016.45. — View Citation

Kemp K, Dibley L, Chauhan U, Greveson K, Jäghult S, Ashton K, Buckton S, Duncan J, Hartmann P, Ipenburg N, Moortgat L, Theeuwen R, Verwey M, Younge L, Sturm A, Bager P. Second N-ECCO Consensus Statements on the European Nursing Roles in Caring for Patient — View Citation

To N, Gracie DJ, Ford AC. The Importance of Smoking Cessation in Improving Disease Course in Crohn's Disease. Am J Gastroenterol. 2016 Aug;111(8):1198. doi: 10.1038/ajg.2016.165. — View Citation

Underner M, Perriot J, Cosnes J, Beau P, Peiffer G, Meurice JC. [Smoking, smoking cessation and Crohn's disease]. Presse Med. 2016 Apr;45(4 Pt 1):390-402. doi: 10.1016/j.lpm.2016.02.008. Epub 2016 Mar 23. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate of patients who had received the 5 A intervention referred to the smoking cessation unit.	Control visits in Hospital smoking cessation Unit	We measure it at baseline and through study completion, 1 year after
Other	The rate of patients who had received the 5 R intervention referred to the smoking cessation unit.	Control visits in Hospital smoking cessation Unit	We measure it at baseline and through study completion, 1 year after
Primary	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
Primary	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	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