Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-12 @ 5:27 AM
Study NCT ID:
NCT05457660
Status:
UNKNOWN
Last Update Posted:
2022-07-14
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the quality of life of colostomized or ileostomized patients in home hospitalization', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Identify patient issues and needs.', 'timeFrame': '4 months'}, {'measure': 'Analyze the results by subgroups of patients: according to the type of stoma (ileostomy vs. colostomy; temporary stomy vs. permanent stoma), age of the stoma, age, pathology.', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Home Hospitalization', 'Colostomy', 'Ileostomy'], 'conditions': ['Colostomy', 'Ileostomy', 'Home Hospitalization']}, 'descriptionModule': {'briefSummary': 'The goalf of the study is to have a basis about QOL for colo-stoma and ileo-stoma for patients which are hospitalized at home. The QOL measurement is done with a questionnaire of several items made by stomatherapist and also using EQ5D QOL form.\n\nAfter reviewing of the data, our goal is to create or improve some solutions to improve their QOL during their home hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stoma : Colostomy and Ileostomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colo-stomy or Ileo-stomy patient\n* Patient hospitalized at home by Fondation Sante Service (Fr)\n* 18 YO or more\n* Non-opposition to the study\n\nExclusion Criteria:\n\n* Patient not able to read or properly understand the Information Consent Form and not able to complete the questionnaire for any reason.'}, 'identificationModule': {'nctId': 'NCT05457660', 'acronym': "STOM'HAD", 'briefTitle': 'Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Sante Service'}, 'officialTitle': 'Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization', 'orgStudyIdInfo': {'id': '2022-A00014-39'}}, 'contactsLocationsModule': {'locations': [{'zip': '92300', 'city': 'Levallois-Perret', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc POTERRE, MD', 'role': 'CONTACT', 'email': 'marc.poterre@fondation-santeservice.fr', 'phone': '+33146970175'}, {'name': 'Baptiste JAUNEAU, Master', 'role': 'CONTACT', 'email': 'baptiste.jauneau@fondation-santeservice.fr', 'phone': '+33146970175'}], 'facility': 'Fondation Santé Service', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Sante Service', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}