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

Ulcerative Colitis Clinical Trial

— ECIPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550158
• Other study ID #: GETAID 2009-1
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 14, 2015
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Procedure:
• Educational program EDU-MICI

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	Hopital Beaujon	Clichy
France	Hopital Louis Mourier	Colombes
France	Hopital Bicetre	Le Kremlin-Bicetre
France	CHRU Lille	Lille
France	Hopital Nord	Marseille
France	Chi Le Raincy Montfermeil	Montfermeil
France	Chu Montpellier	Montpellier
France	Chu Nantes	Nantes
France	CHU NICE	Nice
France	Hopital Saint Louis	Paris
France	Hopital Saint-Antoine	Paris
France	Institut Mutualiste Montsouris	Paris
France	Chu Rouen	Rouen
France	Chu Saint-Etienne	SAINT-PRIEST en JAREZ
France	Chu Toulouse	Toulouse
France	Hopital Tourcoing	Tourcoing
France	Chu Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hospitalization	Number of hospitalizations >24h	6 months after inclusion	No
Secondary	Disease Flare	Number of disease flare	6 months after inclusion	No
Secondary	Major complication	Number of major complication = number of serious adverse events related to the disease	6 months after inclusion	No
Secondary	Quality of life	Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ)	6 months after inclusion	No
Secondary	Observance	Variation of score for the "Observance" questionnaire	6 months after inclusion	No
Secondary	Patient concerns	Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire.	6 months after inclusion	No
Secondary	Work productivity	Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire	6 months after inclusion	No

External Links

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