REspectful CAring for the AGitated Elderly
- Conditions
- Dementia
- Interventions
- Other: SCU-B
- Registration Number
- NCT03507504
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description care pathway with SCU-B 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)
- Primary Outcome Measures
Name Time Method change of BPSD baseline, 6, 12, 18, 24, 30, 36 months Neuropsychiatric Inventory (NPI), range 0-144
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (12)
Assistance Publique - Hopitaux de Paris
🇫🇷Paris, France
Zentralinstitut für Seelische Gesundheit
🇩🇪Mannheim, Baden-Wurttenberg, Germany
Centre Hospitalier Universitaire St Pierre
🇧🇪Bruxelles, Belgium
Aristotelio Panepistimio Thessalonikis (Greece)
🇬🇷Thessaloníki, Greece
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Azienda Socio Sanitaria Territoriale di Mantova
🇮🇹Mantova, MN, Italy
Fondazione Europea di Ricerca Biomedica
🇮🇹Gazzaniga, BG, Italy
Cliniche Gavazzeni SpA
🇮🇹Bergamo, BG, Italy
Università degli Studi di Perugia
🇮🇹Perugia, PG, Italy
Azienda Unità Sanitaria Locale di Modena
🇮🇹Modena, MO, Italy
Sykehuset Innlandet
🇳🇴Ottestad, Norway
Université de Genève
🇨🇭Genève, Switzerland