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CompletedNCT02550158ECIPEUpdated Sep 15, 2015

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

An interventional study of Educational program EDU-MICI in Crohn's Disease and Ulcerative Colitis, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Completed at 18 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
263
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Crohn's Disease
  • Ulcerative Colitis

Keywords

  • Crohn's Disease
  • Ulcerative Colitis
  • Educational program
  • Inflammatory Bowel Disease
  • Psycho-pedagogic score
  • IBD
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 263 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives is the lead sponsor of 35 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria

  • Patients unable to understand and follow the program
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
263 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureEducational program EDU-MICI
06

What researchers measure

Primary outcomes

  1. Psycho-pedagogic score (ECIPE score)

    Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.

    Time frame: 6 months after Inclusion

Secondary outcomes

  1. Hospitalization

    Number of hospitalizations \>24h

    Time frame: 6 months after inclusion

  2. Disease Flare

    Number of disease flare

    Time frame: 6 months after inclusion

  3. Major complication

    Number of major complication = number of serious adverse events related to the disease

    Time frame: 6 months after inclusion

  4. Quality of life

    Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Time frame: 6 months after inclusion

  5. Observance

    Variation of score for the "Observance" questionnaire

    Time frame: 6 months after inclusion

  6. Patient concerns

    Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire.

    Time frame: 6 months after inclusion

  7. Work productivity

    Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire

    Time frame: 6 months after inclusion

07

Study locations

18 sites
  • Chu Amiens
    Amiens, 80054, France
  • Hopital Beaujon
    Clichy, 92110, France
  • Hopital Louis Mourier
    Colombes, 92700, France
  • Hopital Bicetre
    Le Kremlin-Bicetre, 94270, France
  • CHRU Lille
    Lille, France
  • Hopital Nord
    Marseille, 13015, France
  • Chi Le Raincy Montfermeil
    Montfermeil, 93370, France
  • Chu Montpellier
    Montpellier, 34295, France
  • Chu Nantes
    Nantes, 44093, France
  • CHU NICE
    Nice, 06202, France
  • Hopital Saint Louis
    Paris, 75010, France
  • Hopital Saint-Antoine
    Paris, 75012, France
  • Institut Mutualiste Montsouris
    Paris, 75674, France
  • Chu Rouen
    Rouen, 76000, France
  • Chu Saint-Etienne
    SAINT-PRIEST en JAREZ, 42270, France
  • Chu Toulouse
    Toulouse, 31403, France
  • Hopital Tourcoing
    Tourcoing, 59208, France
  • Chu Tours
    Tours, 37044, France
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02550158
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Responsible party
Sponsor
First posted
Sep 15, 2015
Start date
Jun 2011
Primary completion
Nov 2014
Completion
Apr 2015
Last update
Sep 15, 2015

Study contacts

Matthieu Allez, PhD
principal investigator · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Jacques Moreau
principal investigator · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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