A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.

Official Title
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A Randomized Controlled Study Evaluating the Impact of an Educational Program EDU-MICI on Patients With Inflammatory Bowel Disease

Conditions
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Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
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* Procedure: Educational program EDU-MICI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female patients 18 -70 years of age Recent diagnosis (less than 6 months) of Crohn's Disease or ulcerative colitis OR patients with an oldest pathology with a new flare, a complication and / or need to optimize medical therapy Exclusion Criteria Patients unable to understand and follow the program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educated Group<br>Training of patients by the educational program EDU-MICI | Procedure: Educational program EDU-MICI<br> <br> |
| Other: Control group<br>During the first 6 months : no training of patients by the educational program EDU-MICI. Then, a crossover allowed uneducated patients to benefit from the educational program the next 6 months. | Procedure: Educational program EDU-MICI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psycho-pedagogic score (ECIPE score) | Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion. | 6 months after Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Number of hospitalizations >24h | 6 months after inclusion | 
| Disease Flare | Number of disease flare | 6 months after inclusion | 
| Major complication | Number of major complication = number of serious adverse events related to the disease | 6 months after inclusion | 
| Quality of life | Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ) | 6 months after inclusion | 
| Observance | Variation of score for the Observance questionnaire | 6 months after inclusion | 
| Patient concerns | Variation of score for the Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC) questionnaire. | 6 months after inclusion | 
| Work productivity | Variation of score for the Work Productivity and Activity Impairment - General Health (WPAI-GH) questionnaire | 6 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Ulcerative Colitis, Educational program, Inflammatory Bowel Disease, Psycho-pedagogic score, IBD