Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease (EDUMICILOR)

March 16, 2021 updated by: Muriel VELTIN, Central Hospital, Nancy, France

EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD).

During the study, patients will participate in an online therapeutic education program.

They will first have an appointment with a nurse to establish a personalized educational diagnosis. Then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities).

The main objective of this study is to assess the feasibility of an online therapeutic education program for IBD patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France
        • Recruiting
        • CHRU Nancy
        • Contact:
          • Muriel Veltin

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:

  • Male or female (age ≥ 18 years old)
  • Patients with established Crohn's disease or ulcerative colitis diagnosis
  • Patients who own the equipment to participate in the online therapeutic education program (computer, webcam….)
  • French speaking patients
  • Patients who cannot attend regular therapeutic education sessions at the hospital
  • Patients able to understand the information provided to them and to give written informed consent for the study

Exclusion Criteria:

  • Patient who has not given his/her consent to participate

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EDUMICILOR
Patients will participate in the online therapeutic education program for about 6 months
Other: EDUMICILOR
Patients will participate in the online therapeutic education program for about 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of participation in the online therapeutic education program
Time Frame: 6 months
Patients must participate in at least 80% of therapeutic education program sessions and connect to at least one video or one serious game.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of the Crohn and Colitis Knowledge Score
Time Frame: 6 months
The Crohn and Colitis Knowledge Score will assess the impact of the online therapeutic education program on achieving educational objectives.
6 months
Score of the short Inflammatory Bowel Disease Questionnaire (short-IBDQ)
Time Frame: 6 months
The short-IBDQ will assess the quality of life before and after the online therapeutic education program.
6 months
Score of the Inflammatory Bowel Disease Disability Index (IBD Disability Index)
Time Frame: 6 months
The IBD Disability index will be used to assess disability before and after the online therapeutic education program.
6 months
Score of the Hospital Anxiety and Depression Scale
Time Frame: 6 months
The Hospital Anxiety and Depression scale will assess the anxiety and depression level before and after the online therapeutic education program.
6 months
Score of the Girerd Scale
Time Frame: 6 months
The Girerd Scale will be used to assess the level of adherence to prescribed drugs before and after the online therapeutic education program.
6 months
Score of a satisfaction survey on the online therapeutic education program
Time Frame: 6 months
This survey will identify the advantages and disadvantages of an online therapeutic education program.
6 months

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Muriel Veltin, Central Hospital, Nancy, France

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)

January 29, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPARA2018/EDUMICILOR-VELTIN

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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