Clinical trial NCT02550158: A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease
Official title: A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's Disease
Ulcerative Colitis
Educational program
Inflammatory Bowel Disease
Psycho-pedagogic score
IBD
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Psycho-pedagogic score (ECIPE score)
timeFrame: 6 months after Inclusion
Secondary outcomes:
measure: Hospitalization
timeFrame: 6 months after inclusion
measure: Disease Flare
timeFrame: 6 months after inclusion
measure: Major complication
timeFrame: 6 months after inclusion
measure: Quality of life
timeFrame: 6 months after inclusion
measure: Observance
timeFrame: 6 months after inclusion
measure: Patient concerns
timeFrame: 6 months after inclusion
measure: Work productivity
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Clichy
country: France
facility: Hopital Beaujon
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Le Kremlin-Bicetre
country: France
facility: Hopital Bicetre
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: Hopital Nord
city: Montfermeil
country: France
facility: Chi Le Raincy Montfermeil
city: Montpellier
country: France
facility: Chu Montpellier
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Rouen
country: France
facility: Chu Rouen
city: SAINT-PRIEST en JAREZ
country: France
facility: Chu Saint-Etienne
city: Toulouse
country: France
facility: Chu Toulouse
city: Tourcoing
country: France
facility: Hopital Tourcoing
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Matthieu Allez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Jacques Moreau
role: PRINCIPAL_INVESTIGATOR
References: