Efficacy of Doll thErapy Compared With Standard Treatment in the Control of Behavioral and Psychologic Symptoms and CaRegIver Burden of dEmentia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale
研究概览
简要总结
Behavioral and psychologic symptoms in dementia (BPSD) are frequent and represent a burden for patients and caregivers, the use of a first line non-pharmacologic approach is highly recommended. DESCRIBE is a randomized controlled trial on the effect of doll therapy (DT) on BPSD in different clinical settings.
The investigators will enroll fifty-two nursing homes residents and 52 acute in-patients with dementia and BPSD. Subjects will be randomized to DT or standard treatment (ST), The investigators will measured agitation, delirium and caregiver burden with standard clinical scales at baseline and during treatment. Nursing home residents will be evaluated after 45 and 90 days of treatment, in-patients will be evaluated at baseline and at hospital discharge. In acute in-patients, a follow-up of 4 weeks after hospital discharge will be carried out in order to evaluate the effect of DT withdrawal.
Primary outcomes will be the reduction of BPSD and the reduction of professional caregiver burden Secondary outcome will be the reduction of delirium and of effect of family caregiver burden.
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
- Single (Outcomes Assessor)
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;
- •negative interaction with the doll.
结局指标
主要结局
Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale
时间窗: 10-45-90 days
Change in NPI and A.Di.Co scales
Change in professional caregivers burden measured by the Greutzner scale
时间窗: 10-45-90 days
change in professional caregiver burden
次要结局
- Incidence of delirium measured by the Confusion assessment Method (CAM) scale(45 and 90 days)
- Change in caregiver burden measured by the caregiver Burden Inventory (CBI)(28 days)
研究者
Patrizia D'Amelio
associated professor
Centre Hospitalier Universitaire Vaudois