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
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- change of BPSD
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
change of BPSD
时间窗: baseline, 6, 12, 18, 24, 30, 36 months
Neuropsychiatric Inventory (NPI), range 0-144
次要结局
- quality of life of patients(baseline, 6, 12,18, 24, 30, 36 months)
- quality of life of caregivers(baseline, 6, 12, 18, 24, 30, 36 months)
- cost-effectiveness of SCU-B(baseline, 6, 12, 18, 24, 30, 36 months)
研究者
Carlo Alberto Defanti
Study Coordinator
Fondazione Europea di Ricerca Biomedica Ferb Onlus