Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02643069
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Intervention in Frail Older People (FRAILCLINIC)
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-12', 'size': 3280665, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-09-08T12:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 821}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Status assessed using the Barthel index for Basic Activities of Daily Living', 'timeFrame': '36 months', 'description': 'will be assessed using the Barthel index for Basic Activities of Daily Living'}, {'measure': 'Functional Status assessed using the Lawton index for Instrumental Activities of Daily Living', 'timeFrame': '36 months', 'description': 'will be assessed using the Lawton index for Instrumental Activities of Daily Living'}, {'measure': 'Institutionalization (defined as the number of patients newly addressed to nursing)', 'timeFrame': '36 months', 'description': 'defined as the number of patients newly addressed to nursing'}, {'measure': 'Mortality', 'timeFrame': '36 months', 'description': 'number of deaths occurred either during hospitalization or at follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Frailty', 'Frailty tools', 'Clinical settings', 'Disability', 'Quality of life', 'Functional Autonomy'], 'conditions': ['Frailty Syndrome']}, 'referencesModule': {'references': [{'pmid': '25468154', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.'}, {'pmid': '16129869', 'type': 'BACKGROUND', 'citation': 'Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.'}, {'pmid': '11253156', 'type': 'RESULT', 'citation': 'Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.'}, {'pmid': '24559204', 'type': 'RESULT', 'citation': 'Pena FG, Theou O, Wallace L, Brothers TD, Gill TM, Gahbauer EA, Kirkland S, Mitnitski A, Rockwood K. Comparison of alternate scoring of variables on the performance of the frailty index. BMC Geriatr. 2014 Feb 24;14:25. doi: 10.1186/1471-2318-14-25.'}, {'pmid': '24597624', 'type': 'RESULT', 'citation': 'Drubbel I, Numans ME, Kranenburg G, Bleijenberg N, de Wit NJ, Schuurmans MJ. Screening for frailty in primary care: a systematic review of the psychometric properties of the frailty index in community-dwelling older people. BMC Geriatr. 2014 Mar 6;14:27. doi: 10.1186/1471-2318-14-27.'}, {'pmid': '24028357', 'type': 'RESULT', 'citation': 'Theou O, Brothers TD, Mitnitski A, Rockwood K. Operationalization of frailty using eight commonly used scales and comparison of their ability to predict all-cause mortality. J Am Geriatr Soc. 2013 Sep;61(9):1537-51. doi: 10.1111/jgs.12420. Epub 2013 Aug 26.'}, {'pmid': '22836700', 'type': 'RESULT', 'citation': 'Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.'}]}, 'descriptionModule': {'briefSummary': 'Frailty is the main risk factor for the development of incident disability in older people and one of the most important for other adverse outcomes (death, hospitalisation, falls, and permanent institutionalisation).\n\nAlthough frailty is a frequent condition in older adults who attend hospitals, little is known about its true prevalence in different settings of care. Better knowledge of this issue will inform the rational design of more effective strategies aimed at providing fitted care for these patients. Thus, the current study will potentially have impact on the quality of care for frail patients by revealing the prevalence of frailty in different settings of care, the difficulties in detection and management of frailty in these settings and the best instruments to detect frailty.\n\nThe investigators proposal brings together 6 partners in the European Union (EU) from three countries, with the common aim of studying the feasibility of a program to detect frail older patients in high risk clinical settings.', 'detailedDescription': 'Quality assurance plan:\n\n* To perform regular monitoring according to the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP): The data will be evaluated according to the protocol and source documents.\n* To give training to the centres involved in the study.\n* To check the electronic Case Report Form (eCRF)\n\nData checks to compare data entered into the registry:\n\nThe eCRF has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none id card number will not be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.\n\nPlan for missing data to address situations where variables are reported as missing:\n\nThe investigators will check the missing data in each eCRF and source documents.\n\nStatistical analysis:\n\nData will be analyzed using STATA®. Descriptive statistics will be reported and histograms will assess the distribution of frailty scores in each scale. Each analysis will be categorised according to frail, prefrail or robust patients.The prevalence of frailty will be calculated for each scale based on the score thresholds and relationships between frailty and age and other variables will be evaluated. Agreement among scales will be examined using the Cohen kappa statistic. Receiver operator characteristic (ROC) curves will be constructed to compare the area under the ROC curve (AUC) for each scale for available outcomes.\n\nSample Size: A minimum of 50 patients will be studied in each clinical setting, providing a database of 900 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Frailty patients older than 75 years old attended in the settings of care.\n2. Willing and able to provide informed consent\n\nExclusion Criteria:\n\n1. Lack of capacity to give informed consent.\n2. Those unable or unwilling to cooperate with any of the assessments'}, 'identificationModule': {'nctId': 'NCT02643069', 'acronym': 'FRAILCLINIC', 'briefTitle': 'Clinical Intervention in Frail Older People (FRAILCLINIC)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Getafe'}, 'officialTitle': 'Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)', 'orgStudyIdInfo': {'id': '20131208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Geriatric Program', 'description': 'A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, according to the treating physicians (s) surgeon and the performance of a geriatrician . This management will consist of the therapeutic plan, access to geriatric levels of care, coordination with primary and social care, rehabilitation, and discharge plan.', 'interventionNames': ['Other: Intervention Geriatric Program']}, {'type': 'NO_INTERVENTION', 'label': 'Usual clinical practice', 'description': 'A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, agreed with the treating physicians (s) surgeon.'}], 'interventions': [{'name': 'Intervention Geriatric Program', 'type': 'OTHER', 'description': 'The investigators will implemented programs to detected and manage care for older patients in four settings: Emergency room, oncology department, surgery departments making major surgery and Cardiology. The core intervention will consist of the following elements: comprehensive geriatric assessment, coordination with primary ans social care, integrated and continued care, access to rehabilitation facilities, management of drug treatment avoiding polypharmacy and stressing adherence.', 'armGroupLabels': ['Intervention Geriatric Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28905', 'city': 'Getafe', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hopsital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}], 'overallOfficials': [{'name': 'Leocadio Rodriguez Mañas, IP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Getafe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Getafe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}