NCT03507504

REspectful CAring for the AGitated Elderly

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Dementia

Interventions

Type	Name	Description
OTHER	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".

Timeline

• Start date: 2018-04-19
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-04-25
• Last updated: 2019-08-01

Locations

12 sites across 7 countries: Belgium, France, Germany, Greece, Italy, Norway, Switzerland