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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02550158

Acronym

ECIPE

Enrollment

263

Registered

2015-09-15

Start date

2011-06-30

Completion date

2015-04-30

Last updated

2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Crohn's Disease, Ulcerative Colitis, Educational program, Inflammatory Bowel Disease, Psycho-pedagogic score, IBD

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.

Interventions

PROCEDUREEducational program EDU-MICI

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026