Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 10:10 PM
Study NCT ID:
NCT04337957
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2019-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elderly Patients With Renal Insufficiency: Reasons for Using the Geriatrician, Modalities and Results of the Geriatric Evaluation, Becoming at One Year
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2020-04-04', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "reason for the nephrologist's recourse for a geriatric assessment with a geriatric team", 'timeFrame': 'up to one year', 'description': 'geriatric syndromes recorded from medical records'}], 'secondaryOutcomes': [{'measure': 'geriatric advice for therapeutic project including dialysis option', 'timeFrame': 'up to one year', 'description': 'rate of geriatric advice for therapeutic project including dialysis option listed from medical records'}, {'measure': 'falls recorded from geriatric assessment medical records', 'timeFrame': 'up to one year', 'description': 'number of falls recorded from geriatric assessment medical records'}, {'measure': 'death,assessment from medical records', 'timeFrame': 'at one year', 'description': 'number of death recorded from medical records'}, {'measure': 'dialyses and death recorded from medical records', 'timeFrame': 'at one year', 'description': 'rate of dialyses and death recorded from medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Evaluation Criteria', 'Comorbidities and Coexisting Conditions', 'Motility Disorder']}, 'descriptionModule': {'briefSummary': 'The incidence and prevalence of kidney failure increases with age. Elderly people with chronic kidney disease may have factors of fragility (loss of independence, comorbidities, geriatric syndromes) that can complicate the choice and implementation of the nephrological therapeutic project. Joint and early assessment of these patients by a nephrologist and a geriatrician could help to optimize the definition of care objectives and patient pathway.\n\nThere is little data on how nephrologists and geriatricians cooperate and on the description of frailties in elderly patients with renal impairment.\n\nIn this context, the objective of this study is to describe in a French university hospital the reasons for the use of geriatricians by nephrologists, the modalities of geriatric evaluation and the socio-demographic and medical characteristics (including geriatric syndromes) of very elderly patients with renal insufficiency, and then to become so at one year.\n\nYear of implementation of this research: 2019 based on data from 2017 and 2019. Approximate number of people likely to be included in the research: 100 patients', 'detailedDescription': 'There is little data on how nephrologists and geriatricians cooperate and on the description of frailties in elderly patients with renal impairment.\n\nIn this context, the objective of this study is to describe in a French university hospital the reasons for the use of geriatricians by nephrologists, the modalities of geriatric evaluation and the socio-demographic and medical characteristics (including geriatric syndromes) of very elderly patients with renal insufficiency, and then to become so at one year.\n\nSecondary objectives :\n\n* describe the modalities of the geriatric evaluation\n* describe the socio-demographic, medical characteristics (including fragilities and/or geriatric syndromes) of elderly patients with renal insufficiency\n* describe how to become one year old.\n\nOrigin and nature of the data collected:\n\n\\- Socio-demographic, medical and geriatric data (see attached document) based on geriatric assessment medical records (reports of external geriatric consultation and/or intervention by the mobile geriatric team).\n\nThe approximate duration of the study will be 9 months. This time includes the time required for statistical analysis and writing an article.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very old patients with renal insufficiency', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 75-year-old patient and older\n* Renal insufficiency\n* Use in 2017 and 2018 of a geriatric evaluation at the Nîmes University Hospital at the request of nephrologists (mobile geriatric team or external geriatric consultation).\n\nExclusion Criteria:\n\n* Patient under guardianship, curatorship or judicial protection\n* Patient under 75-year-old'}, 'identificationModule': {'nctId': 'NCT04337957', 'acronym': 'NephroG', 'briefTitle': 'Elderly Patients With Renal Insufficiency: Reasons for Using the Geriatrician, Modalities and Results of the Geriatric Evaluation, Becoming at One Year', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Elderly Patients With Renal Insufficiency: Reasons for Using the Geriatrician, Modalities and Results of the Geriatric Evaluation, Becoming at One Year', 'orgStudyIdInfo': {'id': 'Local/2019/VA-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'geriatric nephrology', 'type': 'OTHER', 'description': "Collection of the geriatrician's opinion"}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}