Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT06491706
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2024-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Outcomes in Older Patients With Physical Restraint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063507', 'term': 'Sexism'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D011287', 'term': 'Prejudice'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D063508', 'term': 'Social Discrimination'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one year mortaliy', 'timeFrame': 'ONE year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical restraint', 'emergency department', 'biological sex', 'long-term mortality'], 'conditions': ['Physical Restraint', 'Gender Bias', 'Morality']}, 'descriptionModule': {'briefSummary': 'The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.\n\nThis study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.\n\nThis retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.\n\nThe population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive older patients ≥ 75-year-old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED\n* If physical restraint were mentioned in medical records\n\nExclusion Criteria:\n\n* if patients were less than 75 years old\n* Without physical restraint\n* Not hospitalized\n* If a patient was admitted more than once, only the first episode was taken as index admission'}, 'identificationModule': {'nctId': 'NCT06491706', 'briefTitle': 'Long-term Outcomes in Older Patients With Physical Restraint', 'organization': {'class': 'OTHER', 'fullName': 'Beaujon Hospital'}, 'officialTitle': 'The Association of Biological Sex and Long-term Outcomes in Older Patients With Physical Restraint at the Emergency Department', 'orgStudyIdInfo': {'id': 'urgBjNpr'}}, 'armsInterventionsModule': {'interventions': [{'name': 'the was no intervention', 'type': 'OTHER', 'description': 'there was no intervention in this observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hopital BEAUJON', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}], 'overallOfficials': [{'name': 'Prabakar VAITTINADA AYAR, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Beaujon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beaujon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prabakar VAITTINADA AYAR', 'investigatorAffiliation': 'Beaujon Hospital'}}}}