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

NCT ID: NCT02550158

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-04-30

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.

Detailed Description

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Conditions

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Crohn's Disease Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Educated Group

Training of patients by the educational program "EDU-MICI"

Group Type EXPERIMENTAL

Educational program EDU-MICI

Intervention Type PROCEDURE

Control group

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.

Group Type OTHER

Educational program EDU-MICI

Intervention Type PROCEDURE

Interventions

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Educational program EDU-MICI

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu Allez, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Jacques Moreau

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Locations

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Chu Amiens

Amiens, , France

Site Status

Hopital Beaujon

Clichy, , France

Site Status

Hopital Louis Mourier

Colombes, , France

Site Status

Hopital Bicetre

Le Kremlin-BicĂȘtre, , France

Site Status

CHRU Lille

Lille, , France

Site Status

Hopital Nord

Marseille, , France

Site Status

Chi Le Raincy Montfermeil

Montfermeil, , France

Site Status

Chu Montpellier

Montpellier, , France

Site Status

Chu Nantes

Nantes, , France

Site Status

CHU NICE

Nice, , France

Site Status

Hopital Saint Louis

Paris, , France

Site Status

Hopital Saint-Antoine

Paris, , France

Site Status

Institut Mutualiste Montsouris

Paris, , France

Site Status

Chu Rouen

Rouen, , France

Site Status

Chu Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status

Chu Toulouse

Toulouse, , France

Site Status

Hopital Tourcoing

Tourcoing, , France

Site Status

Chu Tours

Tours, , France

Site Status

Countries

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France

References

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Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

Related Links

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Other Identifiers

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GETAID 2009-1

Identifier Type: -

Identifier Source: org_study_id

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