Ulcerative Colitis Clinical Trial
— EDUMICILOROfficial title:
Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | April 1, 2023 |
| Est. primary completion date | April 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Nancy | Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 months | |
| Secondary | 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. | 6 months | |
| Secondary | 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. | 6 months | |
| Secondary | 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. | 6 months | |
| Secondary | 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. | 6 months | |
| Secondary | 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. | 6 months | |
| Secondary | 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. | 6 months |
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