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

Not Applicable

Completed

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Procedure: Educational program EDU-MICI

• Registration Number: NCT02550158
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2014-11
• Study Completion: 2015-04
• Status Verified: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-14
• Last Update Submitted: 2015-09-14
• Study First Posted: 2015-09-15
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Educated Group	Educational program EDU-MICI	Training of patients by the educational program "EDU-MICI"
Control group	Educational program EDU-MICI	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.

Primary Outcome Measures

Name	Time	Method
Psycho-pedagogic score (ECIPE score)	6 months after Inclusion	Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Hopital Louis Mourier; 🇫🇷 Colombes, France

Hopital Bicetre; 🇫🇷 Le Kremlin-Bicetre, France

Hopital Beaujon; 🇫🇷 Clichy, France

Hopital Nord; 🇫🇷 Marseille, France

Chu Nantes; 🇫🇷 Nantes, France

Chi Le Raincy Montfermeil; 🇫🇷 Montfermeil, France

Hopital Saint Louis; 🇫🇷 Paris, France

CHU NICE; 🇫🇷 Nice, France

Hopital Saint-Antoine; 🇫🇷 Paris, France

Chu Saint-Etienne; 🇫🇷 SAINT-PRIEST en JAREZ, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Chu Toulouse; 🇫🇷 Toulouse, France

Hopital Tourcoing; 🇫🇷 Tourcoing, France

Chu Tours; 🇫🇷 Tours, France

Chu Rouen; 🇫🇷 Rouen, France

Chu Amiens; 🇫🇷 Amiens, France

CHRU Lille; 🇫🇷 Lille, France

Chu Montpellier; 🇫🇷 Montpellier, France