Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 3:48 PM
Study NCT ID:
NCT00450034
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2007-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 665}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2007-03-19', 'studyFirstSubmitQcDate': '2007-03-19', 'lastUpdatePostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of unplanned readmissions, including emergency consultations,', 'timeFrame': 'during the study'}], 'secondaryOutcomes': [{'measure': 'Mortality at 6 months,', 'timeFrame': 'at 6 months'}, {'measure': 'delay before readmission,', 'timeFrame': 'before readmission'}, {'measure': 'number of drug events related readmissions.', 'timeFrame': 'readmissions'}, {'measure': 'Data collected at 3 and 6 months', 'timeFrame': 'at 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Frail Elderly', 'Patient Education', 'Drug optimization', 'Underuse', 'Vulnerable', 'Drug related hospitalization', 'Medical intervention'], 'conditions': ['Global Medical Assessment of Elderly Frail Patients']}, 'referencesModule': {'references': [{'pmid': '22091692', 'type': 'RESULT', 'citation': 'Legrain S, Tubach F, Bonnet-Zamponi D, Lemaire A, Aquino JP, Paillaud E, Taillandier-Heriche E, Thomas C, Verny M, Pasquet B, Moutet AL, Lieberherr D, Lacaille S. A new multimodal geriatric discharge-planning intervention to prevent emergency visits and rehospitalizations of older adults: the optimization of medication in AGEd multicenter randomized controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2017-28. doi: 10.1111/j.1532-5415.2011.03628.x. Epub 2011 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.', 'detailedDescription': 'Drug treatment in elderly is not yet optimal. 20 to 30% of admissions of elderly aged over 80 are related to drug problems, most of them being preventable. To decrease drug related hospitalizations need iatrogenic prevention, compliance improvement, and underuse decrease. A multifaceted intervention has been designed, included three dimensions : 1/ drug optimization 2/ patient and/or caregiver education and 3/ better coordination with home health professionals before discharge.\n\nA randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized as a matter of urgency in unity(unit) of geriatrics acute\n* Patients of more than 70 years old\n* Hospitalization in the Unity(Unit) of Geriatrics foreseen(planned) superior acute in 5 days\n* enlightened assent writing and signed\n* preliminary medical examination\n\nExclusion Criteria:\n\n* Patients in scheduled(programmed) hospitalization\n* Patient in palliative care\n* Patient whose vital forecast is engaged(opened) in 3 months\n* Patient already include during a previous hospitalization Patient already included in a study concerning the therapeutic care\n* Followed medical impossible (refusal of care, absence of alive regular, patient doctor abroad)\n* not membership to a regime of Social Security or CMU\n* Patient not speaking French'}, 'identificationModule': {'nctId': 'NCT00450034', 'acronym': 'OMAGE', 'briefTitle': 'Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial', 'orgStudyIdInfo': {'id': 'P060247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Procedure: drug - oriented multifaceted intervention']}], 'interventions': [{'name': 'drug - oriented multifaceted intervention', 'type': 'PROCEDURE', 'description': 'oriented multifaceted intervention', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Chu Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Sylvie LEGRAIN, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}