Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT05625867
Status:
RECRUITING
Last Update Posted:
2024-11-05
First Post:
2022-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000657744', 'term': 'postintensive care syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 404}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MOS SF-36 Quality of Life Scale Score', 'timeFrame': 'Between 4/5 and 9 months after discharge from intensive care'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Intensive Care Syndrome']}, 'descriptionModule': {'briefSummary': 'A patient\'s stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.\n\nNumerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.\n\nAll patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.\n\nOne month after discharge from the ICU, the patients will be randomly assigned to\n\n* either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit\n* or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who has given oral consent\n* Patient 18 years of age or older\n* Patient with at least one organ failure\n* Patient with a stay of 6 days or more\n\nExclusion Criteria:\n\n* Person who is not affiliated or not a beneficiary of a social security system\n* Patient at the end of his/her life\n* Patient who does not speak French\n* Minor (\\< 18 years old)\n* Person subject to a legal protection measure (curatorship, guardianship)\n* Person subject to a legal protection measure\n* Pregnant, parturient or breastfeeding women\n* Patient incarcerated\n* Patient with a psychiatric history'}, 'identificationModule': {'nctId': 'NCT05625867', 'acronym': 'COPRéa', 'briefTitle': 'Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit', 'orgStudyIdInfo': {'id': 'LAURENT UB 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU', 'interventionNames': ['Other: Psychological and quality of life questionnaires', 'Other: Interdisciplinary consultation at 4/5 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient managed under standard practice conditions', 'interventionNames': ['Other: Psychological and quality of life questionnaires']}], 'interventions': [{'name': 'Psychological and quality of life questionnaires', 'type': 'OTHER', 'description': 'At 4/5 months and at 9 months', 'armGroupLabels': ['Patient managed under standard practice conditions', 'Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU']}, {'name': 'Interdisciplinary consultation at 4/5 months', 'type': 'OTHER', 'description': 'About ten days after the questionnaires were administered', 'armGroupLabels': ['Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandra LAURENT', 'role': 'CONTACT', 'email': 'alexandra.laurent@u-bourgogne.fr', 'phone': '03 80 39 39 77'}], 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Alexandra LAURENT', 'role': 'CONTACT', 'email': 'alexandra.laurent@u-bourgogne.fr', 'phone': '03 80 39 39 77'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}