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Crohn DiseaseNCT04225403

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

A study testing Telephone-based motivational interviewing for smoking cessation in people with Crohn Disease, run by Hospital Universitari Vall d'Hebron Research Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Telephone-based motivational interviewing for smoking cessation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
No sites listed yet
Study dates
6 Nov 2015to 8 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Smokers Crohn's disease patients
  • >18 age

Who cannot join

  • Smokers Crohn's disease patients who are receiving treatment of tobacco cessation at the time of inclusion
  • Do not have email

About this study

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

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
Being tested
Telephone-based motivational interviewing for smoking cessation
Keywords
Inflammatory Bowel Disease, Smoking cessation, Tobacco, Smoking, Advanced practice nurse, Motivational intervention
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases, Smoking Cessation, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone-based motivational interviewing for smoking cessationBehavioural

    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.
Study groups in NCT04225403
Study groupRoleWhat they receive
Telephone-based motivational interviewingExperimentalExperimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year, performed by IBD nurse
Receives: Behavioral: Telephone-based motivational interviewing for smoking cessation
usual careNo interventionNo intervention consisted of a single telephone contact one year after the star of the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: We measure it at baseline and through study completion, 1 year after

  2. 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.

    Measured: We measure it at baseline and through study completion, 1 year after

Secondary outcomes (1)

  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.

    Cosnes classification: current smokers >7 cigarettes per week for at least 6 months, former smokers who had stopped smoking at least 6 months before.

    Measured: We measure it at baseline and through study completion, 1 year after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start6 Nov 2015
  3. Primary completion8 May 2017
  4. Study completion8 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04225403
Sponsor's protocol ID
PR(AG)275/2013
Status last verified
Jan 2020
First submitted
23 Dec 2019
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11266373

  • 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.

    PubMed 27018116

  • 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.

    PubMed 29509882

  • 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.

    PubMed 27016849

  • 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.

    PubMed 26981632

  • 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.

    PubMed 27481416

  • 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.

    PubMed 34269705

Questions about this trial

What is this clinical trial studying?

A study testing Telephone-based motivational interviewing for smoking cessation in people with Crohn Disease, run by Hospital Universitari Vall d'Hebron Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from motivation to quit smoking after at one year in the control group and in the experimental group (time frame: We measure it at baseline and through study completion, 1 year after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04225403, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.

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