Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT05163457
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Frailty Among People Aged 75 and Over Living at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty', 'timeFrame': 'Day 0', 'description': 'Frailty evaluated using SEGA modified scale (SEGAm). SEGAm includes 13 items (coded from 0 to 2) to obtain a global score out of 26 points. Patients with a score less than or equal to 8 are considered not fragile. Patients with a score between 8 and 11 are considered fragile. Patients with a score greater than or equal to 11 are considered very fragile.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty - SEGAm - living at home'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard.\n\nThe SEGAm showed its usefulness in aged patients living at home.', 'detailedDescription': 'The aim of the study is to describe prevalence of frailty in patients aged of 75 and more living at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged of 75 and more living at home', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female\n* aged of 75 and more\n* living at home\n* agreeing to participate in the study\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT05163457', 'acronym': 'FRAIL-DOM', 'briefTitle': 'Prevalence of Frailty Among People Aged 75 and Over Living at Home', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Prevalence of Frailty Among People Aged 75 and Over Living at Home', 'orgStudyIdInfo': {'id': '2021-012-FRAIL-DOM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'aged of 75 and more living at home', 'description': 'aged of 75 and more living at home" group: patients aged of 75 and more living at home', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'frailty evaluation', 'armGroupLabels': ['aged of 75 and more living at home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10110', 'city': 'Bar-sur-Seine', 'state': 'Grand Est', 'country': 'France', 'facility': 'Maison de Santé Pluridisciplinaire de Bar sur Seine', 'geoPoint': {'lat': 48.11295, 'lon': 4.37656}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}