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
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). 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
Study Type
OBSERVATIONAL
Enrollment
500
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".
Centre Hospitalier Universitaire St Pierre
Brussels, Belgium
NOT_YET_RECRUITINGAssistance Publique - Hopitaux de Paris
Paris, France
NOT_YET_RECRUITINGchange of BPSD
Neuropsychiatric Inventory (NPI), range 0-144
Time frame: baseline, 6, 12, 18, 24, 30, 36 months
quality of life of patients
Quality of Life Alzheimer's Disease (QoL-AD), range 0-52
Time frame: baseline, 6, 12,18, 24, 30, 36 months
quality of life of caregivers
Caregiver Burden Inventory (CBI), range 0-96
Time frame: baseline, 6, 12, 18, 24, 30, 36 months
cost-effectiveness of SCU-B
Resource Utilisation in Dementia (RUD)
Time frame: baseline, 6, 12, 18, 24, 30, 36 months
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Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttenberg, Germany
NOT_YET_RECRUITINGCharité - Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGAristotelio Panepistimio Thessalonikis (Greece)
Thessaloniki, Greece
RECRUITINGCliniche Gavazzeni SpA
Bergamo, BG, Italy
NOT_YET_RECRUITINGFondazione Europea di Ricerca Biomedica
Gazzaniga, BG, Italy
RECRUITINGAzienda Socio Sanitaria Territoriale di Mantova
Mantua, MN, Italy
RECRUITINGAzienda Unità Sanitaria Locale di Modena
Modena, MO, Italy
NOT_YET_RECRUITINGUniversità degli Studi di Perugia
Perugia, PG, Italy
NOT_YET_RECRUITING...and 2 more locations