Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT04515160
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2020-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Clinical Frailty Scale and Modified Frailty Index in Intensive Care Patients
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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty', 'timeFrame': 'in the first 24 hours of intensive care admissions', 'description': "the correlation of the Clinical Frailty Scale, which is a judgment-based measure, and the Modified Frailty Index, which interrogates the patient's current diseases, in the frailty assessment of intensive care patients"}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'the patient will be monitored for 1 year and the exitus time will be recorded', 'description': 'effect of the clinical frailty scale and modified farilty index on the estimation of mortality'}, {'measure': 'intensive care stay', 'timeFrame': 'the patient will be monitored for 1 year and the intensive care stay will be recorded', 'description': 'effect of the clinical frailty scale and modified farilty index on the estimation of intensive care stay'}, {'measure': 'discharge status', 'timeFrame': 'the patient will be monitored for 1 year and the discharge status will be recorded', 'description': 'effect of the clinical frailty scale and modified farilty index on the estimation of discharge status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': "The purpose of our study is to evaluate the correlation of the Clinical Frailty Scale, which is a judgment-based measure, and the Modified Frailty Index, which interrogates the patient's current diseases, in the frailty assessment of intensive care patients and the effect on the estimation of mortality, mechanical ventilation need, intensive care stay, hospital stay and discharge status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'intensive care patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intensive care patients\n\nExclusion Criteria:\n\n* patients with a life expectancy of less than 24 hours\n* Do not speak Turkish'}, 'identificationModule': {'nctId': 'NCT04515160', 'briefTitle': 'Correlation of Clinical Frailty Scale and Modified Frailty Index in Intensive Care Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'Correlation of Clinical Frailty Scale and Modified Frailty Index in Intensive Care Patients', 'orgStudyIdInfo': {'id': '92/04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clinical Frailty Scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical fragility scale will be recorded in the first 24 hours of intensive care admissions.'}, {'name': 'Modified Frailty Index', 'type': 'DIAGNOSTIC_TEST', 'description': 'Modified Frailty Index will be recorded in the first 24 hours of intensive care admissions.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Bahar SAKIZCI UYAR', 'role': 'CONTACT', 'email': 'drsakizciuyar@gmail.com'}], 'facility': 'DiskapiYBERH', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Bahar SAKIZCI UYAR', 'role': 'CONTACT', 'email': 'drsakizciuyar@gmail.com', 'phone': '5057000240'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Bahar SAKIZCI UYAR', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}