Clinical trial NCT04225403: Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: Inflammatory Bowel Disease
Smoking cessation
Tobacco
Smoking
Advanced practice nurse
Motivational intervention
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal
name: Department of Health, Generalitat de Catalunya
First posted: 2020-01-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from motivation to quit smoking after at one year in the control group and in the experimental group
timeFrame: We measure it at baseline and through study completion, 1 year after
measure: Change from stages of changes to quit smoking after at one year in the control group and in the experimental group
timeFrame: We measure it at baseline and through study completion, 1 year after
Secondary outcomes:
measure: 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.
timeFrame: We measure it at baseline and through study completion, 1 year after
Other outcomes:
measure: The rate of patients who had received the 5 A intervention referred to the smoking cessation unit.
timeFrame: We measure it at baseline and through study completion, 1 year after
measure: The rate of patients who had received the 5 R intervention referred to the smoking cessation unit.
timeFrame: We measure it at baseline and through study completion, 1 year after
Locations:
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Ester Navarro Correal, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1053/gast.2001.23231.
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.
citation: Kemp K, Dibley L, Chauhan U, Greveson K, Jaghult 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 Patients with Crohn's Disease or Ulcerative Colitis. J Crohns Colitis. 2018 Jun 28;12(7):760-776. doi: 10.1093/ecco-jcc/jjy020. No abstract available.
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. French.
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.
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. No abstract available.
citation: Navarro Correal E, Casellas Jorda F, Borruel Sainz N, Robles Alonso V, Herrera de Guise C, Ibarz Casas A, Sanchez Garcia JM, Vila Morte G, Fuentelsaz Gallego C. Effectiveness of a Telephone-Based Motivational Intervention for Smoking Cessation in Patients With Crohn Disease: A Randomized, Open-Label, Controlled Clinical Trial. Gastroenterol Nurs. 2021 Nov-Dec 01;44(6):418-425. doi: 10.1097/SGA.0000000000000572.