Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone-based motivational interviewing for smoking cessation
Sponsored by
About this trial
This is an interventional supportive care trial for Crohn Disease focused on measuring Inflammatory Bowel Disease, Smoking cessation, Tobacco, Smoking, Advanced practice nurse, Motivational intervention
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telephone-based motivational interviewing
usual care
Arm Description
Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year, performed by IBD nurse
No intervention consisted of a single telephone contact one year after the star of the study
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04225403
First Posted
December 23, 2019
Last Updated
January 10, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal, Department of Health, Generalitat de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT04225403
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2015 (Actual)
Primary Completion Date
May 8, 2017 (Actual)
Study Completion Date
May 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal, Department of Health, Generalitat de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Inflammatory Bowel Disease, Smoking cessation, Tobacco, Smoking, Advanced practice nurse, Motivational intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone-based motivational interviewing
Arm Type
Experimental
Arm Description
Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year, performed by IBD nurse
Arm Title
usual care
Arm Type
No Intervention
Arm Description
No intervention consisted of a single telephone contact one year after the star of the study
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based motivational interviewing for smoking cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from motivation to quit smoking after at one year in the control group and in the experimental group
Description
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
Time Frame
We measure it at baseline and through study completion, 1 year after
Title
Change from stages of changes to quit smoking after at one year in the control group and in the experimental group
Description
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.
Time Frame
We measure it at baseline and through study completion, 1 year after
Secondary Outcome Measure Information:
Title
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.
Description
Cosnes classification: current smokers >7 cigarettes per week for at least 6 months, former smokers who had stopped smoking at least 6 months before.
Time Frame
We measure it at baseline and through study completion, 1 year after
Other Pre-specified Outcome Measures:
Title
The rate of patients who had received the 5 A intervention referred to the smoking cessation unit.
Description
Control visits in Hospital smoking cessation Unit
Time Frame
We measure it at baseline and through study completion, 1 year after
Title
The rate of patients who had received the 5 R intervention referred to the smoking cessation unit.
Description
Control visits in Hospital smoking cessation Unit
Time Frame
We measure it at baseline and through study completion, 1 year after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Navarro Correal, MsC
Organizational Affiliation
Hospital Universitari Vall d'Hebron Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11266373
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.
Results Reference
result
PubMed Identifier
27018116
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.
Results Reference
result
PubMed Identifier
29509882
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.
Results Reference
result
PubMed Identifier
27016849
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.
Results Reference
result
PubMed Identifier
26981632
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.
Results Reference
result
PubMed Identifier
27481416
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.
Results Reference
result
PubMed Identifier
34269705
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.
Results Reference
derived
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Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients
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