Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-08 @ 5:31 AM
Study NCT ID:
NCT02871557
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2016-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty and the Elderly in Martinique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 weeks'}, {'measure': 'Nursing home admission', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 month'}, {'measure': 'Mortality', 'timeFrame': '12 month'}, {'measure': 'Mortality', 'timeFrame': '24 month'}, {'measure': 'Mortality', 'timeFrame': '36 month'}, {'measure': 'Nursing home admission', 'timeFrame': '6 month'}, {'measure': 'Nursing home admission', 'timeFrame': '12 month'}, {'measure': 'Nursing home admission', 'timeFrame': '24 month'}, {'measure': 'Nursing home admission', 'timeFrame': '36 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elderly People With Polypathology or Disabilities']}, 'referencesModule': {'references': [{'pmid': '26919847', 'type': 'RESULT', 'citation': 'Godard-Sebillotte C, Drame M, Basileu T, Fanon JL, Godaert L. Is self-rated health an independent prognostic factor of six-week mortality in older patients hospitalized for an acute condition? Qual Life Res. 2016 Sep;25(9):2335-40. doi: 10.1007/s11136-016-1252-3. Epub 2016 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).', 'detailedDescription': "The SAFMA cohort was an ad hoc study formed into the recruitment of the acute care for elders in the geriatric department of Martinique university Hospitals. The inclusion of subjects ran from January 1st 2012 to June 30th 2012. To be eligible, patients had to be 75 or over and hospitalised for acute condition. Each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was performed by visits and telephone interview till 36 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A group of elderly people hospitalised in acute care for elders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 75 years or over\n* Admitted to acute care for elders\n* Consent to participate\n\nExclusion Criteria:\n\n* Impossibility to perform the tests\n* Refusals to participate'}, 'identificationModule': {'nctId': 'NCT02871557', 'acronym': 'SAFMACohort', 'briefTitle': 'Frailty and the Elderly in Martinique', 'organization': {'class': 'OTHER', 'fullName': 'Société Martiniquaise de Gérontologie et Gériatrie'}, 'officialTitle': 'Frail Elderly Subjects Martinique: Adverse Outcome After Hospitalisation in Geriatric Department', 'orgStudyIdInfo': {'id': '1958830'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société Martiniquaise de Gérontologie et Gériatrie', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHU de Reims', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Lidvine Godaert', 'investigatorAffiliation': 'Société Martiniquaise de Gérontologie et Gériatrie'}}}}