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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

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date February 11, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
Official Title  ICMJE Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Crohn's Disease
  • Ulcerative Colitis
Intervention  ICMJE Other: EDUMICILOR
Patients will participate in the online therapeutic education program for about 6 months
Study Arms  ICMJE EDUMICILOR
Patients will participate in the online therapeutic education program for about 6 months
Intervention: Other: EDUMICILOR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muriel Veltin 0033383154187 muriel.veltin@micilor.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648398
Other Study ID Numbers  ICMJE APPARA2018/EDUMICILOR-VELTIN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muriel Veltin Central Hospital, Nancy, France
PRS Account Central Hospital, Nancy, France
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP