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

NCT ID: NCT04225403

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-06

Study Completion Date

2017-05-08

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telephone-based motivational interviewing

Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year, performed by IBD nurse

Group Type EXPERIMENTAL

Telephone-based motivational interviewing for smoking cessation

Intervention Type 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.

usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal

UNKNOWN

Sponsor Role collaborator

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ester Navarro Correal, MsC

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron Research Institute

References

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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.

Reference Type RESULT
PMID: 11266373 (View on PubMed)

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.

Reference Type RESULT
PMID: 27018116 (View on PubMed)

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.

Reference Type RESULT
PMID: 29509882 (View on PubMed)

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.

Reference Type RESULT
PMID: 27016849 (View on PubMed)

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.

Reference Type RESULT
PMID: 26981632 (View on PubMed)

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.

Reference Type RESULT
PMID: 27481416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34269705 (View on PubMed)

Other Identifiers

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PR(AG)275/2013

Identifier Type: -

Identifier Source: org_study_id

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