Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT03971851
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2019-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Novel Frailty Index in Surgical Cohorts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30-days', 'description': 'Mortality within 30 days of surgery in each of the three frailty risk groups'}, {'measure': 'Time to hospital readmission', 'timeFrame': 'Up to 180 days', 'description': 'For patients surviving index hospitalization, the proportional hazard ratio of readmission between the three frailty group'}], 'secondaryOutcomes': [{'measure': 'Long-term mortality', 'timeFrame': 'Up to 14 years', 'description': 'Long-term mortality of the three different frailty risk groups, compared with proportional hazard modeling'}, {'measure': 'Prolonged hospital length-of stay', 'timeFrame': '3 months', 'description': 'Incidence of patients staying more than 10-days after surgery in the three frailty risk cohorts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery--Complications', 'Anesthesia Morbidity', 'Perioperative Complication']}, 'descriptionModule': {'briefSummary': 'This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals over 65 years of age undergoing surgery at a University Hospital Setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved\n\nExclusion Criteria:\n\n* No American Society of Anesthesiology classification provided'}, 'identificationModule': {'nctId': 'NCT03971851', 'briefTitle': 'Validation of a Novel Frailty Index in Surgical Cohorts', 'organization': {'class': 'OTHER', 'fullName': 'University of Iceland'}, 'officialTitle': 'Testing and Validation of a Novel Frailty Index in a Surgical Cohort', 'orgStudyIdInfo': {'id': 'FrailtyAndSurgery'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low frailty', 'description': 'Frailty risk score less than 5', 'interventionNames': ['Other: Frailty risk groups']}, {'label': 'Intermediate Frailty', 'description': 'Frailty risk score 5-15', 'interventionNames': ['Other: Frailty risk groups']}, {'label': 'High frailty', 'description': 'Frailty risk score 15 and above', 'interventionNames': ['Other: Frailty risk groups']}], 'interventions': [{'name': 'Frailty risk groups', 'type': 'OTHER', 'description': 'Patients older than 65 will be separated into groups of varying frailty risk', 'armGroupLabels': ['High frailty', 'Intermediate Frailty', 'Low frailty']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin I Sigurdsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iceland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Just summary data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iceland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}