Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- behavioural and psychological symptoms of dementia
研究概览
简要总结
Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events.
The investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia.
The use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥65 years
- •diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2
- •presence of agitation and/or aggressiveness
- •manual and visual abilities sufficient in order to interact with the doll.
排除标准
- •age <65 years;
- •refuse to participate;
- •mild forms of dementia (CDR<2);
- •contraindication for DT as experience of mournful or traumatic events related to parental experience;
- •life expectancy lower than 3 months;
- •infectious diseases requiring isolation;
- •negative interaction with the doll,
- •presence of delirium.
结局指标
主要结局
behavioural and psychological symptoms of dementia
时间窗: baseline, discharge (up to one week)
Neuro Psychiatic Inventory (NPI). The NPI total score ranges from 0 to 144, higher scores means more severe and frequent behavioural and psycological symptoms of dementia
agitation and aggressiveness within hospital
时间窗: baseline and hospital discharge discharge (up to one week)
measured by Pittsburgh Agitation Scale (PAS). the score ranges between 0 to 16 on the PAS the higher score means the higher agitation
agitation and aggressiveness outside hospital
时间窗: baseline, 1 and 4 weeks after discharge
Cohen Mansfield Inventory scale (CMAI). the score ranges betwen 0 and 203, with higher scores indicating more agitation
次要结局
- patients' quality of life(baseline and 4 weeks after discharge)
- family caregivers' quality of life(baseline and 4 weeks after discharge)
- family caregiver burden(baseline and 4 weeks after discharge)
- professional caregiver burden(baseline and at hospital discharge (up to one week))
- incidence of delirium(every day during hospital stay (up to one week))
研究者
Patrizia D'Amelio
Full professor, head of the geriatric and Geriatric rehabilitation Service
Centre Hospitalier Universitaire Vaudois