Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-04-13 @ 10:15 PM
Study NCT ID:
NCT03814161
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FRailty Among Elderly Emergency Department Patients With Outcome Measures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2018-10-12', 'studyFirstSubmitQcDate': '2019-01-20', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-month Adverse Event Occurrence (composite)', 'timeFrame': 'At 1 month after index ED visit', 'description': 'Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality'}], 'secondaryOutcomes': [{'measure': '3-month Adverse Event Occurrence (composite)', 'timeFrame': 'At 3 months after index ED visit', 'description': 'Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geriatric, Frailty, Emergency Department']}, 'referencesModule': {'references': [{'pmid': '23764209', 'type': 'BACKGROUND', 'citation': 'Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.'}]}, 'descriptionModule': {'briefSummary': 'Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS), Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F), which can potentially be adopted for daily practice in the busy ED. It is timely as we projected that we will be seeing more elderly patients attending the ED for various medical and surgical conditions. Their attendance at the ED would be a good opportunity to screen for frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or subsequent hospitalisation that might lead to poor functional outcomes and higher dependence on step-down care facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients aged 65 years and above attending Emergency Department, National University Hospital, Singapore irrespective of reason for attendance and are planned for discharge from the Emergency Department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Elderly patients aged 65 years and above attending ED irrespective of reason for attendance.\n\nExclusion Criteria:\n\n* Haemodynamically unstable patients\n* Inability to obtain informed consent\n* Inability to obtain reliable information from patient or caregiver (e.g. deafness, blindness, language barriers)\n* Vulnerable populations (e.g. prisoners)\n* Patients who are planned for hospital admission from the ED'}, 'identificationModule': {'nctId': 'NCT03814161', 'acronym': 'FREEDOM', 'briefTitle': 'FRailty Among Elderly Emergency Department Patients With Outcome Measures', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'FRailty Among Elderly Emergency Department Patients With Outcome Measures', 'orgStudyIdInfo': {'id': 'FREEDOM'}}, 'contactsLocationsModule': {'locations': [{'zip': '119085', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital, Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Ying Wei Yau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}