Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT02550158
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2015-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2015-09-11', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psycho-pedagogic score (ECIPE score)', 'timeFrame': '6 months after Inclusion', 'description': 'Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': '6 months after inclusion', 'description': 'Number of hospitalizations \\>24h'}, {'measure': 'Disease Flare', 'timeFrame': '6 months after inclusion', 'description': 'Number of disease flare'}, {'measure': 'Major complication', 'timeFrame': '6 months after inclusion', 'description': 'Number of major complication = number of serious adverse events related to the disease'}, {'measure': 'Quality of life', 'timeFrame': '6 months after inclusion', 'description': 'Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ)'}, {'measure': 'Observance', 'timeFrame': '6 months after inclusion', 'description': 'Variation of score for the "Observance" questionnaire'}, {'measure': 'Patient concerns', 'timeFrame': '6 months after inclusion', 'description': 'Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire.'}, {'measure': 'Work productivity', 'timeFrame': '6 months after inclusion', 'description': 'Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'Ulcerative Colitis', 'Educational program', 'Inflammatory Bowel Disease', 'Psycho-pedagogic score', 'IBD'], 'conditions': ["Crohn's Disease", 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '40243391', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.getaid.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Male or female patients 18 -70 years of age\n* 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\n\nExclusion Criteria\n\n* Patients unable to understand and follow the program"}, 'identificationModule': {'nctId': 'NCT02550158', 'acronym': 'ECIPE', 'briefTitle': 'A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}, 'officialTitle': 'A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'GETAID 2009-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educated Group', 'description': 'Training of patients by the educational program "EDU-MICI"', 'interventionNames': ['Procedure: Educational program EDU-MICI']}, {'type': 'OTHER', 'label': 'Control group', '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.', 'interventionNames': ['Procedure: Educational program EDU-MICI']}], 'interventions': [{'name': 'Educational program EDU-MICI', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group', 'Educated Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Chu Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hopital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Hopital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hopital Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'Chi Le Raincy Montfermeil', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Chu Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '31403', 'city': 'Toulouse', 'country': 'France', 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'facility': 'Hopital Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Chu Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Matthieu Allez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}, {'name': 'Jacques Moreau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}