Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease (EDUMICILOR)
Primary Purpose
Crohn's Disease, Ulcerative Colitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EDUMICILOR
Sponsored by
About this trial
This is an interventional supportive care trial for Crohn's Disease focused on measuring Therapeutic education program, Online
Eligibility 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
Sites / Locations
- CHRU NancyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
EDUMICILOR
Arm Description
Patients will participate in the online therapeutic education program for about 6 months
Outcomes
Primary Outcome Measures
Frequency of participation in the online therapeutic education program
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
Score of the Crohn and Colitis Knowledge Score
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)
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)
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
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
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
This survey will identify the advantages and disadvantages of an online therapeutic education program.
Full Information
NCT ID
NCT03648398
First Posted
August 22, 2018
Last Updated
March 16, 2021
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03648398
Brief Title
Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
Acronym
EDUMICILOR
Official Title
Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis
Keywords
Therapeutic education program, Online
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EDUMICILOR
Arm Type
Other
Arm Description
Patients will participate in the online therapeutic education program for about 6 months
Intervention Type
Other
Intervention Name(s)
EDUMICILOR
Intervention Description
Patients will participate in the online therapeutic education program for about 6 months
Primary Outcome Measure Information:
Title
Frequency of participation in the online therapeutic education program
Description
Patients must participate in at least 80% of therapeutic education program sessions and connect to at least one video or one serious game.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Score of the Crohn and Colitis Knowledge Score
Description
The Crohn and Colitis Knowledge Score will assess the impact of the online therapeutic education program on achieving educational objectives.
Time Frame
6 months
Title
Score of the short Inflammatory Bowel Disease Questionnaire (short-IBDQ)
Description
The short-IBDQ will assess the quality of life before and after the online therapeutic education program.
Time Frame
6 months
Title
Score of the Inflammatory Bowel Disease Disability Index (IBD Disability Index)
Description
The IBD Disability index will be used to assess disability before and after the online therapeutic education program.
Time Frame
6 months
Title
Score of the Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression scale will assess the anxiety and depression level before and after the online therapeutic education program.
Time Frame
6 months
Title
Score of the Girerd Scale
Description
The Girerd Scale will be used to assess the level of adherence to prescribed drugs before and after the online therapeutic education program.
Time Frame
6 months
Title
Score of a satisfaction survey on the online therapeutic education program
Description
This survey will identify the advantages and disadvantages of an online therapeutic education program.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muriel Veltin
Phone
0033383154187
Email
muriel.veltin@micilor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muriel Veltin
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel Veltin
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
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