Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 4:49 PM
Study NCT ID:
NCT04085432
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Frailty Self Assessment Tool
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty and pre-frailty diagnosis rate', 'timeFrame': 'October 2019 to August 2020', 'description': "Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried's frailty phenotype assessment"}], 'secondaryOutcomes': [{'measure': 'Prevalence of frailty by age and gender', 'timeFrame': 'October 2019 to August 2020', 'description': 'Prevalence of frailty by age and gender'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.', 'detailedDescription': "Five thousands (5000) retirees aged 70 and over will be randomly selected from National Retirement Pension Institute (CNAV) retirees (2500 living in Paris and 2500 living in Toulouse). They will receive a letter from the CNAV explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to International Longevity Centre France (ILC-France).\n\nRetirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the Fried's frailty criteria in order to confirm or infirm the diagnosis of frailty.\n\nThe General practitioner will be informed of the investigation results in order to set up a personalized prevention plan.\n\nILC-France will anonymize both the self-administered questionnaires and the Fried assessments and send them to the Mixed Research Unit (UMR) 1027 in Toulouse.\n\nComparison of the Fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire.\n\nSecondary analyses will be conducted to compare the prevalence of frailty by age and gender.\n\nThe statistical analysis is carried out by the UMR 1027 of Toulouse."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retirees aged 70 and over, living at home', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retirees from the National Old-Age Insurance Fund\n* Aged 70 or older,\n* Living at home\n* Representatives of the general population\n\nExclusion Criteria:\n\n* Institutionalized retirees\n* Retirees receiving the Personalised Allowance for Autonomy\n* Retirees who enrolled in previous studies'}, 'identificationModule': {'nctId': 'NCT04085432', 'briefTitle': 'Validation of a Frailty Self Assessment Tool', 'organization': {'class': 'OTHER', 'fullName': 'International Longevity Centre France'}, 'officialTitle': 'Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over', 'orgStudyIdInfo': {'id': 'CNAV- ILC France 2'}, 'secondaryIdInfos': [{'id': '2018-A03324-51', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Self administered questionnaire and Clinical evaluation', 'type': 'OTHER', 'description': 'Self administered questionnaire and clinical evaluation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Broca Hospital Geriatric Department', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'GERONTOPOLE of the Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Françoise FORETTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ILC France and Universite Paris Descartes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Longevity Centre France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}