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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648398
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Other: EDUMICILOR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648398


Contacts
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Contact: Muriel Veltin 0033383154187 muriel.veltin@micilor.com

Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Muriel Veltin Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03648398    
Other Study ID Numbers: APPARA2018/EDUMICILOR-VELTIN
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Therapeutic education program
Online
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases