Dementia
Conditions
Keywords
psychiatric aspects
Brief summary
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
Detailed description
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
Interventions
OTHERSCU-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.
Sponsors
Mediolanum Cardio Research
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* diagnosis of primary dementia (DSM IV) * 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
* presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD * concomitant psychiatric disorders or chronic alcoholism * concomitant diseases severe enough to reduce life expectancy \< 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of BPSD | baseline, 6, 12, 18, 24, 30, 36 months | Neuropsychiatric Inventory (NPI), range 0-144 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life of patients | baseline, 6, 12,18, 24, 30, 36 months | Quality of Life Alzheimer's Disease (QoL-AD), range 0-52 |
| quality of life of caregivers | baseline, 6, 12, 18, 24, 30, 36 months | Caregiver Burden Inventory (CBI), range 0-96 |
| cost-effectiveness of SCU-B | baseline, 6, 12, 18, 24, 30, 36 months | Resource Utilisation in Dementia (RUD) |
Other
| Measure | Time frame | Description |
|---|---|---|
| delayed institutionalisation | until 3 years | Time to nursing home placement |
Countries
Belgium, France, Germany, Greece, Italy, Norway, Switzerland
Contacts
Primary ContactCarla Finocchiaro, Ph.D.
Backup ContactSara Fascendini, M.D.
Outcome results
None listed