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

Primary Purpose

Crohn's Disease, Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Educational program EDU-MICI
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Crohn's Disease focused on measuring Crohn's Disease, Ulcerative Colitis, Educational program, Inflammatory Bowel Disease, Psycho-pedagogic score, IBD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu Amiens
  • Hopital Beaujon
  • Hopital Louis Mourier
  • Hopital Bicetre
  • CHRU Lille
  • Hopital Nord
  • Chi Le Raincy Montfermeil
  • Chu Montpellier
  • Chu Nantes
  • CHU NICE
  • Hopital Saint Louis
  • Hopital Saint-Antoine
  • Institut Mutualiste Montsouris
  • Chu Rouen
  • Chu Saint-Etienne
  • Chu Toulouse
  • Hopital Tourcoing
  • Chu Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Educated Group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2015
Last Updated
September 14, 2015
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT02550158
Brief Title
A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease
Acronym
ECIPE
Official Title
A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis
Keywords
Crohn's Disease, Ulcerative Colitis, Educational program, Inflammatory Bowel Disease, Psycho-pedagogic score, IBD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educated Group
Arm Type
Experimental
Arm Description
Training of patients by the educational program "EDU-MICI"
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Educational program EDU-MICI
Primary Outcome Measure Information:
Title
Psycho-pedagogic score (ECIPE score)
Description
Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.
Time Frame
6 months after Inclusion
Secondary Outcome Measure Information:
Title
Hospitalization
Description
Number of hospitalizations >24h
Time Frame
6 months after inclusion
Title
Disease Flare
Description
Number of disease flare
Time Frame
6 months after inclusion
Title
Major complication
Description
Number of major complication = number of serious adverse events related to the disease
Time Frame
6 months after inclusion
Title
Quality of life
Description
Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame
6 months after inclusion
Title
Observance
Description
Variation of score for the "Observance" questionnaire
Time Frame
6 months after inclusion
Title
Patient concerns
Description
Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire.
Time Frame
6 months after inclusion
Title
Work productivity
Description
Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire
Time Frame
6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu Allez, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Moreau
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Hopital Bicetre
City
Le Kremlin-Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Chi Le Raincy Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU NICE
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Chu Saint-Etienne
City
SAINT-PRIEST en JAREZ
ZIP/Postal Code
42270
Country
France
Facility Name
Chu Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Hopital Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.getaid.org
Description
Related Info

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

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