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

NCT04225403 | Completed DMC

• 1 other identifier: PR(AG)275/2013
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Disease; Smoking cessation; Tobacco; Smoking; Advanced practice nurse; Motivational intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• 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

• 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

Study Arms (2)

Telephone-based motivational interviewing

EXPERIMENTAL

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

usual care

NO INTERVENTION

No intervention consisted of a single telephone contact one year after the star of the study

Interventions

Telephone-based motivational interviewing for smoking cessation BEHAVIORAL

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.

Telephone-based motivational interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers Crohn's disease patients
• \>18 age

You may not qualify if:

• Do not have email

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal: collaborator
• Department of Health, Generalitat de Catalunya: collaborator

Related Publications (7)

• 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.

  PMID: 11266373 RESULT

• 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.

  PMID: 27018116 RESULT

• 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.

  PMID: 29509882 RESULT

• 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.

  PMID: 27016849 RESULT

• 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.

  PMID: 26981632 RESULT

• 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.

  PMID: 27481416 RESULT

• 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.

  PMID: 34269705 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Health Behavior; Behavior

Study Officials

• Ester Navarro Correal, MsC

  Hospital Universitari Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 13, 2020
• Study Start: November 6, 2015
• Primary Completion: May 8, 2017
• Study Completion: May 8, 2017
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share