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

Not Applicable

• Conditions: Crohn's Disease; Ulcerative Colitis
• Interventions: Other: EDUMICILOR

• Registration Number: NCT03648398
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2021-01-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EDUMICILOR	EDUMICILOR	Patients will participate in the online therapeutic education program for about 6 months

Primary Outcome Measures

Name	Time	Method
Frequency of participation in the online therapeutic education program	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

Name	Time	Method
Score of the Crohn and Colitis Knowledge Score	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)	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)	6 months	The IBD Disability index will be used to assess disability before and after the online therapeutic education program.
Score of the Girerd Scale	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	6 months	This survey will identify the advantages and disadvantages of an online therapeutic education program.
Score of the Hospital Anxiety and Depression Scale	6 months	The Hospital Anxiety and Depression scale will assess the anxiety and depression level before and after the online therapeutic education program.

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France