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

September 14, 2015 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Colombes, France, 92700
        • Hopital Louis Mourier
      • Le Kremlin-Bicetre, France, 94270
        • Hôpital Bicêtre
      • Lille, France
        • CHRU Lille
      • Marseille, France, 13015
        • Hôpital Nord
      • Montfermeil, France, 93370
        • CHI Le Raincy Montfermeil
      • Montpellier, France, 34295
        • CHU Montpellier
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75012
        • Hôpital Saint-Antoine
      • Paris, France, 75010
        • Hopital saint Louis
      • Paris, France, 75674
        • Institut Mutualiste Montsouris
      • Rouen, France, 76000
        • CHU Rouen
      • SAINT-PRIEST en JAREZ, France, 42270
        • CHU Saint-Etienne
      • Toulouse, France, 31403
        • CHU Toulouse
      • Tourcoing, France, 59208
        • Hopital Tourcoing
      • Tours, France, 37044
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educated Group
Training of patients by the educational program "EDU-MICI"
Procedure: Educational program EDU-MICI
Other: 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.
Procedure: Educational program EDU-MICI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psycho-pedagogic score (ECIPE score)
Time Frame: 6 months after Inclusion
Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.
6 months after Inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Matthieu Allez, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Principal Investigator: Jacques Moreau, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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