Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2018-04-19
2021-12-31
Brief Summary
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Detailed Description
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At the same time the quality of life of the primary caregivers will be measured, as well as their attitude toward dementia.
A 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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care pathway with SCU-B
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)
SCU-B
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".
care pathway without SCU-B
250 patients with dementia and BPSD followed up by six clinical centres without SCU-B
No interventions assigned to this group
Interventions
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SCU-B
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".
Eligibility Criteria
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Inclusion Criteria
* MMSE score ≤ 24
* NPI global score ≥ 32/144
* a caregiver (informal/family member or formal caregiver) who commits her/himself to accompany the patient along the three-year course of the study
* living at home (nursing home residents are excluded).
Exclusion Criteria
* concomitant psychiatric disorders or chronic alcoholism
* concomitant diseases severe enough to reduce life expectancy \< 6 months
ALL
No
Sponsors
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Mediolanum Cardio Research
OTHER
Fondazione Europea di Ricerca Biomedica Ferb Onlus
OTHER
Responsible Party
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Carlo Alberto Defanti
Study Coordinator
Principal Investigators
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Carlo A Defanti, M.D.
Role: STUDY_DIRECTOR
Fondazione Europea di Ricerca Biomedica
Locations
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Centre Hospitalier Universitaire St Pierre
Brussels, , Belgium
Assistance Publique - Hopitaux de Paris
Paris, , France
Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttenberg, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Aristotelio Panepistimio Thessalonikis (Greece)
Thessaloniki, , Greece
Cliniche Gavazzeni SpA
Bergamo, BG, Italy
Fondazione Europea di Ricerca Biomedica
Gazzaniga, BG, Italy
Azienda Socio Sanitaria Territoriale di Mantova
Mantova, MN, Italy
Azienda Unità Sanitaria Locale di Modena
Modena, MO, Italy
Università degli Studi di Perugia
Perugia, PG, Italy
Sykehuset Innlandet
Ottestad, , Norway
Université de Genève
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
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.
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.
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.
Other Identifiers
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H2020 Proposal, number: 779237
Identifier Type: -
Identifier Source: org_study_id
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