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

January 10, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Behavioral: 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.
NO_INTERVENTION: usual care
No intervention consisted of a single telephone contact one year after the star of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
We measure it at baseline and through study completion, 1 year after
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.
We measure it at baseline and through study completion, 1 year after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
We measure it at baseline and through study completion, 1 year after

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
We measure it at baseline and through study completion, 1 year after
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
We measure it at baseline and through study completion, 1 year after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

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

Investigators

  • Principal Investigator: Ester Navarro Correal, MsC, Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2015

Primary Completion (ACTUAL)

May 8, 2017

Study Completion (ACTUAL)

May 8, 2017

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

January 9, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)275/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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