Crohn's DiseaseECIPENCT02550158
A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease
A study testing Educational program EDU-MICI in people with Crohn's Disease and Ulcerative Colitis, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Educational program EDU-MICI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 18 sitesFrance
- Study dates
- Jun 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients unable to understand and follow the program
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Chu Amiens
Amiens, 80054
Hopital Beaujon
Clichy, 92110
Hopital Louis Mourier
Colombes, 92700
Hopital Bicetre
Le Kremlin-Bicêtre, 94270
CHRU Lille
Lille
Hopital Nord
Marseille, 13015
Chi Le Raincy Montfermeil
Montfermeil, 93370
Chu Montpellier
Montpellier, 34295
Chu Nantes
Nantes, 44093
CHU NICE
Nice, 06202
Hopital Saint Louis
Paris, 75010
Hopital Saint-Antoine
Paris, 75012
Institut Mutualiste Montsouris
Paris, 75674
Chu Rouen
Rouen, 76000
Chu Saint-Etienne
Saint-Priest-en-Jarez, 42270
Chu Toulouse
Toulouse, 31403
Hopital Tourcoing
Tourcoing, 59208
Chu Tours
Tours, 37044
About this study
Official title: 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Educational program EDU-MICI
- Keywords
- Crohn's Disease, Ulcerative Colitis, Educational program, Inflammatory Bowel Disease, Psycho-pedagogic score, IBD
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program EDU-MICIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Educated Group | Experimental | Training of patients by the educational program "EDU-MICI" Receives: 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. Receives: Procedure: Educational program EDU-MICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psycho-pedagogic score (ECIPE score)
Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.
Measured: 6 months after Inclusion
Secondary outcomes (7)
Hospitalization
Number of hospitalizations >24h
Measured: 6 months after inclusion
Disease Flare
Number of disease flare
Measured: 6 months after inclusion
Major complication
Number of major complication = number of serious adverse events related to the disease
Measured: 6 months after inclusion
Quality of life
Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: 6 months after inclusion
Observance
Variation of score for the "Observance" questionnaire
Measured: 6 months after inclusion
Patient concerns
Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire.
Measured: 6 months after inclusion
Work productivity
Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJun 2011
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Allez, PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesJacques Moreau, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550158
- Sponsor's protocol ID
- GETAID 2009-1
- Acronym
- ECIPE
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02550158
- Acronym / sponsor ID
- ECIPE / GETAID 2009-1
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's Disease, Ulcerative Colitis, Educational program, Inflammatory Bowel Disease, Psycho-pedagogic score, IBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educated Group | Experimental | Procedure: Educational program EDU-MICITraining of patients by the educational program "EDU-MICI" |
| Control group | Other | Procedure: Educational program EDU-MICIDuring 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients unable to understand and follow the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational program EDU-MICI | Procedure or surgery | Control group, Educated Group |
Primary outcome
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.
7 secondary outcomes
Hospitalization
Time frame: 6 months after inclusion
Disease Flare
Time frame: 6 months after inclusion
Major complication
Time frame: 6 months after inclusion
Quality of life
Time frame: 6 months after inclusion
Observance
Time frame: 6 months after inclusion
Patient concerns
Time frame: 6 months after inclusion
Work productivity
Time frame: 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Derived from this study: PubMed 40243391Tiles-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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program EDU-MICI in people with Crohn's Disease and Ulcerative Colitis, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psycho-pedagogic score (ECIPE score) (time frame: 6 months after Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.