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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
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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