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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status: Completed

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Procedure: Educational program EDU-MICI

Study type: Interventional

Funder types: Other

Identifiers

NCT02550158

GETAID 2009-1

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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263 participants in 2 patient groups

Educated Group

Experimental group

Description:

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

Treatment:

Procedure: Educational program EDU-MICI

Control group

Other group

Description:

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.

Treatment:

Procedure: Educational program EDU-MICI