NCT02550158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

3.4 years

First QC Date

September 11, 2015

Last Update Submit

September 14, 2015

Conditions

Crohn's DiseaseUlcerative Colitis

Keywords

Crohn's DiseaseUlcerative ColitisEducational programInflammatory Bowel DiseasePsycho-pedagogic scoreIBD

Outcome Measures

Primary Outcomes (1)

  • Psycho-pedagogic score (ECIPE score)

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

    6 months after Inclusion

Secondary Outcomes (7)

  • Hospitalization

    6 months after inclusion

  • Disease Flare

    6 months after inclusion

  • Major complication

    6 months after inclusion

  • Quality of life

    6 months after inclusion

  • Observance

    6 months after inclusion

  • +2 more secondary outcomes

Study Arms (2)

Educated Group

EXPERIMENTAL

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

Procedure: Educational program EDU-MICI

Control group

OTHER

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

Educational program EDU-MICIPROCEDURE
Control groupEducated Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients unable to understand and follow the program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Chu Amiens

Amiens, 80054, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Louis Mourier

Colombes, 92700, France

Location

Hopital Bicetre

Le Kremlin-BicĂȘtre, 94270, France

Location

CHRU Lille

Lille, France

Location

Hopital Nord

Marseille, 13015, France

Location

Chi Le Raincy Montfermeil

Montfermeil, 93370, France

Location

Chu Montpellier

Montpellier, 34295, France

Location

Chu Nantes

Nantes, 44093, France

Location

CHU NICE

Nice, 06202, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Institut Mutualiste Montsouris

Paris, 75674, France

Location

Chu Rouen

Rouen, 76000, France

Location

Chu Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Chu Toulouse

Toulouse, 31403, France

Location

Hopital Tourcoing

Tourcoing, 59208, France

Location

Chu Tours

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 40243391DERIVED

Related Links

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Matthieu Allez, PhD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

  • Jacques Moreau

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

June 1, 2011

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

FR(18)