Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT04812834
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening of the Frailty Degree in the Emergency Department Short Stay Unit
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To know the degree of frailty with the frail VIG index in patients admitted to the short-stay unit', 'timeFrame': '12 months', 'description': 'The Frail Vig index ("VIG" is the spanish/catalan abbreviation for Comprehensive Geriatric Assessment) is a new, more concise Frailty index for rapid geriatric assessment, which contains 22 simple questions that assess 25 different deficits. The Frail VIG index score assesses the degree of frailty as a continuous variable. The value of the Frail VIG index is between 0 (absence of frailty) and 0.7 (severe frailty)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elderly', 'frailty', 'short stay unit'], 'conditions': ['Frail Elderly Syndrome']}, 'referencesModule': {'references': [{'pmid': '29706363', 'type': 'RESULT', 'citation': 'Searle SD, Rockwood K. What proportion of older adults in hospital are frail? Lancet. 2018 May 5;391(10132):1751-1752. doi: 10.1016/S0140-6736(18)30907-3. Epub 2018 Apr 26. No abstract available.'}, {'pmid': '28029467', 'type': 'RESULT', 'citation': 'Amblas-Novellas J, Martori JC, Molist Brunet N, Oller R, Gomez-Batiste X, Espaulella Panicot J. [Frail-VIG index: Design and evaluation of a new frailty index based on the Comprehensive Geriatric Assessment]. Rev Esp Geriatr Gerontol. 2017 May-Jun;52(3):119-127. doi: 10.1016/j.regg.2016.09.003. Epub 2016 Oct 28. Spanish.'}, {'pmid': '29373968', 'type': 'RESULT', 'citation': 'Amblas-Novellas J, Martori JC, Espaulella J, Oller R, Molist-Brunet N, Inzitari M, Romero-Ortuno R. Frail-VIG index: a concise frailty evaluation tool for rapid geriatric assessment. BMC Geriatr. 2018 Jan 26;18(1):29. doi: 10.1186/s12877-018-0718-2.'}, {'pmid': '28587850', 'type': 'RESULT', 'citation': 'Chong E, Ho E, Baldevarona-Llego J, Chan M, Wu L, Tay L. Frailty and Risk of Adverse Outcomes in Hospitalized Older Adults: A Comparison of Different Frailty Measures. J Am Med Dir Assoc. 2017 Jul 1;18(7):638.e7-638.e11. doi: 10.1016/j.jamda.2017.04.011. Epub 2017 Jun 3.'}, {'pmid': '31813278', 'type': 'RESULT', 'citation': 'Damluji AA, Forman DE, van Diepen S, Alexander KP, Page RL 2nd, Hummel SL, Menon V, Katz JN, Albert NM, Afilalo J, Cohen MG; American Heart Association Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Older Adults in the Cardiac Intensive Care Unit: Factoring Geriatric Syndromes in the Management, Prognosis, and Process of Care: A Scientific Statement From the American Heart Association. Circulation. 2020 Jan 14;141(2):e6-e32. doi: 10.1161/CIR.0000000000000741. Epub 2019 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'Screen all those\\> 65 years of age admitted to the Short Stay Unit for frailty, and detect those who are potentially fragile.', 'detailedDescription': 'Demographic change has led to a change in the profile and age of hospitalized patients, an increase in age and in patients with multiple chronic diseases and more complex health needs is observed.\n\nFrailty is known to impact patient health outcomes with medical and surgical procedures. Thus, frailty is correlated with a greater presence of delirium, longer stays, a greater requirement for complementary examinations, a greater presence of mortality and other post-surgical complications, more dependence, more risks derived from hospitalization, and a greater need for convalescence after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the Short Stay Unit of a 550-bed Urban and University Tertiary Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 65 years of age admitted to the Short Stay Unit\n\nExclusion Criteria:\n\n* Patients under 65 years of age admitted to the Short Stay Unit'}, 'identificationModule': {'nctId': 'NCT04812834', 'briefTitle': 'Screening of the Frailty Degree in the Emergency Department Short Stay Unit', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Systematic Detection and Screening of the Frailty Degree in Patients Admitted to the Emergency Department Short Stay Unit', 'orgStudyIdInfo': {'id': 'IIBSP-FRA-2020-74'}}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Josep JA Montiel Dacosta, PhDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}