Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-24 @ 9:42 PM
Study NCT ID:
NCT03507504
Status:
UNKNOWN
Last Update Posted:
2019-08-01
First Post:
2018-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REspectful CAring for the AGitated Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-10-23', 'releaseDate': '2022-12-26'}, {'resetDate': '2024-04-18', 'releaseDate': '2023-10-28'}, {'resetDate': '2024-09-18', 'releaseDate': '2024-04-19'}], 'estimatedResultsFirstSubmitDate': '2022-12-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'delayed institutionalisation', 'timeFrame': 'until 3 years', 'description': 'Time to nursing home placement'}], 'primaryOutcomes': [{'measure': 'change of BPSD', 'timeFrame': 'baseline, 6, 12, 18, 24, 30, 36 months', 'description': 'Neuropsychiatric Inventory (NPI), range 0-144'}], 'secondaryOutcomes': [{'measure': 'quality of life of patients', 'timeFrame': 'baseline, 6, 12,18, 24, 30, 36 months', 'description': "Quality of Life Alzheimer's Disease (QoL-AD), range 0-52"}, {'measure': 'quality of life of caregivers', 'timeFrame': 'baseline, 6, 12, 18, 24, 30, 36 months', 'description': 'Caregiver Burden Inventory (CBI), range 0-96'}, {'measure': 'cost-effectiveness of SCU-B', 'timeFrame': 'baseline, 6, 12, 18, 24, 30, 36 months', 'description': 'Resource Utilisation in Dementia (RUD)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychiatric aspects'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '20947112', 'type': 'BACKGROUND', 'citation': 'Koskas P, Belqadi S, Mazouzi S, Daraux J, Drunat O. [Behavioral and psychological symptoms of dementia in a pilot psychogeriatric unit: management and outcomes]. Rev Neurol (Paris). 2011 Mar;167(3):254-9. doi: 10.1016/j.neurol.2010.07.030. Epub 2010 Oct 14. French.'}, {'pmid': '23523558', 'type': 'BACKGROUND', 'citation': 'Delphin-Combe F, Roubaud C, Martin-Gaujard G, Fortin ME, Rouch I, Krolak-Salmon P. [Effectiveness of a cognitive-behavioral unit on behavioral and psychological symptoms of dementia]. Rev Neurol (Paris). 2013 Jun-Jul;169(6-7):490-4. doi: 10.1016/j.neurol.2012.10.017. Epub 2013 Mar 21. French.'}, {'pmid': '9071445', 'type': 'BACKGROUND', 'citation': 'Bianchetti A, Benvenuti P, Ghisla KM, Frisoni GB, Trabucchi M. An Italian model of dementia special care unit: results of a pilot study. Alzheimer Dis Assoc Disord. 1997 Mar;11(1):53-6. doi: 10.1097/00002093-199703000-00009.'}, {'pmid': '38489173', 'type': 'DERIVED', 'citation': "Cesana BM, Bergh S, Ciccone A, Cognat E, Fabbo A, Fascendini S, Frisoni GB, Froelich L, Handels R, Jori MC, Mecocci P, Merlo P, Peters O, Tsolaki M, Defanti CA. Predictors of Nursing Home Placement in a Cohort of European People with Alzheimer's Disease and Other Dementia Cases Enrolled in SCU-B or Non SCU-B Centers: The RECage Study. J Alzheimers Dis. 2024;98(3):1043-1052. doi: 10.3233/JAD-230878."}]}, 'descriptionModule': {'briefSummary': 'The treatment of Behavioural and Psychological Symptoms of Dementia (BPSD) continue to raise difficult problems. Both the pharmacologic and non-pharmacologic therapies often fail to achieve the expected results. The aim of this study is to assess the short- and long-term efficacy of an intervention, the Special Care Unit for patients with BPSD (SCU-B), already implemented in some countries but not validated so far, as well as its cost-effectiveness', 'detailedDescription': 'Two cohorts of 250 patients each will be recruited by six clinical centres endowed with a SCU-B (one cohort) and six centres lacking this structure. The follow-up will last 3 years, during which patients will be visited every 6 months and submitted to a battery exploring the severity of the BPSD and the quality of life. All adverse events will be registered, as well as some anticipated occurrences (admissions to the general hospital for intercurrent diseases, admissions to a SCU-B pertaining to the clinical participating centre and, if any, admissions to a SCU-B not pertaining to the Consortium member, nursing home placement).\n\nAt the same time the quality of life of the primary caregivers will be measured, as well as their attitude toward dementia.\n\nA cost-effectiveness analysis will be performed comparing the cohorts. Finally the time to the nursing home placement will be recorded and compared between the two cohorts'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population studied is made by the outpatients with dementia referred to the memory clinics of 12 clinical centres located in seven European countries (Italy, Germany, France, Belgium, Greece, Switzerland, Norway)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of primary dementia (DSM IV)\n* MMSE score ≤ 24\n* NPI global score ≥ 32/144\n* a caregiver (informal/family member or formal caregiver) who commits her/himself to accompany the patient along the three-year course of the study\n* living at home (nursing home residents are excluded).\n\nExclusion Criteria:\n\n* presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD\n* concomitant psychiatric disorders or chronic alcoholism\n* concomitant diseases severe enough to reduce life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT03507504', 'acronym': 'RECAGE', 'briefTitle': 'REspectful CAring for the AGitated Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Europea di Ricerca Biomedica Ferb Onlus'}, 'officialTitle': 'REspectful CAring for the AGitated Elderly. How to Best Meet the Needs of People With Dementia With Severe Behavioural Disturbances. Toward a Respectful and Cost-effective Model', 'orgStudyIdInfo': {'id': 'H2020 Proposal, number: 779237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'care pathway with SCU-B', 'description': '250 patients with dementia and behavioural and psychological symptoms of dementia (BPSD) followed up by six clinical centres with a Special Care Unit for BPSD (SCU-B)', 'interventionNames': ['Other: SCU-B']}, {'label': 'care pathway without SCU-B', 'description': '250 patients with dementia and BPSD followed up by six clinical centres without SCU-B'}], 'interventions': [{'name': 'SCU-B', 'type': 'OTHER', 'description': 'SCU-B is "a residential medical structure lying outside of a nursing home, in a general hospital or elsewhere, e.g. in a private hospital, where patients with BPSD are temporarily admitted when their behavioural disturbances are not amenable to control at home".', 'armGroupLabels': ['care pathway with SCU-B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jean P Praet, M.D.', 'role': 'CONTACT', 'email': 'jean-philippe_praet@stpierre-bru.be', 'phone': '+3225354118'}], 'facility': 'Centre Hospitalier Universitaire St Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques Hugon, M.D.', 'role': 'CONTACT', 'email': 'jacques.hugon@inserm.fr', 'phone': '+33149958484'}], 'facility': 'Assistance Publique - Hopitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Mannheim', 'state': 'Baden-Wurttenberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Lutz Froelich, M.D.', 'role': 'CONTACT', 'email': 'lutz.froelich@zi-mannheim.de', 'phone': '+4962117033001'}], 'facility': 'Zentralinstitut für Seelische Gesundheit', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Oliver Peters, M.D.', 'role': 'CONTACT', 'email': 'oliver.peters@charite.de', 'phone': '+4930450517942'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Magda Tsolaki, M.D.', 'role': 'CONTACT', 'email': 'tsolakim1@gmail.com'}, {'role': 'CONTACT', 'phone': '+302310234239'}], 'facility': 'Aristotelio Panepistimio Thessalonikis (Greece)', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Bergamo', 'state': 'BG', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Merlo, M.D.', 'role': 'CONTACT', 'email': 'paola.merlo@gavazzeni.it', 'phone': '+390354204668'}], 'facility': 'Cliniche Gavazzeni SpA', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '24020', 'city': 'Gazzaniga', 'state': 'BG', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Fascendini, M.D.', 'role': 'CONTACT', 'email': 'recage@ferbonlus.com', 'phone': '+390353065206'}, {'name': 'Federica Barocco, M.D.', 'role': 'CONTACT', 'email': 'federica.barocco@ferbonlus.com', 'phone': '+390353065206'}], 'facility': 'Fondazione Europea di Ricerca Biomedica', 'geoPoint': {'lat': 45.79339, 'lon': 9.82976}}, {'city': 'Mantova', 'state': 'MN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alfonso Ciccone, M.D.', 'role': 'CONTACT', 'email': 'alfonso.ciccone@asst-mantova.it', 'phone': '+390376201543'}], 'facility': 'Azienda Socio Sanitaria Territoriale di Mantova', 'geoPoint': {'lat': 45.16031, 'lon': 10.79784}}, {'city': 'Modena', 'state': 'MO', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Fabbo, M.D.', 'role': 'CONTACT', 'email': 'a.fabbo@ausl.mo.it', 'phone': '+39059435201'}], 'facility': 'Azienda Unità Sanitaria Locale di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Perugia', 'state': 'PG', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Mecocci, M.D.', 'role': 'CONTACT', 'email': 'patrizia.mecocci@unipg.it', 'phone': '+390755783270'}], 'facility': 'Università degli Studi di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Ottestad', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Sverre Bergh, M.D.', 'role': 'CONTACT', 'email': 'sverre.bergh@sykehuset-innlandet.no', 'phone': '+4745679393'}], 'facility': 'Sykehuset Innlandet', 'geoPoint': {'lat': 60.74743, 'lon': 11.1366}}, {'city': 'Geneva', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Giovanni B Frisoni, M.D.', 'role': 'CONTACT', 'email': 'giovanni.frisoni@gmail.com', 'phone': '+410223055762'}], 'facility': 'Université de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Carla Finocchiaro, Ph.D.', 'role': 'CONTACT', 'email': 'carla.finocchiaro@cf-c.it', 'phone': '+390231083323'}, {'name': 'Sara Fascendini, M.D.', 'role': 'CONTACT', 'email': 'recage@ferbonlus.com', 'phone': '+390353065206'}], 'overallOfficials': [{'name': 'Carlo A Defanti, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione Europea di Ricerca Biomedica'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available six months after study completion', 'ipdSharing': 'YES', 'description': 'De-identified participant data both for primary and secondary outcome measures will be made available', 'accessCriteria': 'Data access requests will be reviewed by an independent Data Safety Monitoring Board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Europea di Ricerca Biomedica Ferb Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mediolanum Cardio Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Coordinator', 'investigatorFullName': 'Carlo Alberto Defanti', 'investigatorAffiliation': 'Fondazione Europea di Ricerca Biomedica Ferb Onlus'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-12-26', 'type': 'RELEASE'}, {'date': '2023-10-23', 'type': 'RESET'}, {'date': '2023-10-28', 'type': 'RELEASE'}, {'date': '2024-04-18', 'type': 'RESET'}, {'date': '2024-04-19', 'type': 'RELEASE'}, {'date': '2024-09-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Carlo Alberto Defanti, Study Coordinator, Fondazione Europea di Ricerca Biomedica Ferb Onlus'}}}}