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Completed

NCT Number: NCT04225403

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

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.

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Key information

Conditions

Crohn Disease Behavior Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Health Behavior Inflammatory Bowel Diseases Intestinal Diseases Smoking Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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

  2. Change from stages of changes 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

    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 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.

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

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

Other outcomes

  1. The rate of patients who had received the 5 A intervention referred to the smoking cessation unit.

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

    Control visits in Hospital smoking cessation Unit

  2. The rate of patients who had received the 5 R intervention referred to the smoking cessation unit.

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

    Control visits in Hospital smoking cessation Unit

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Department of Health, Generalitat de Catalunya
  • GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2020
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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