NCT00732329已完成不适用
Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Alzheimer's Disease Cooperative Study/Activities of Daily Living
研究概览
简要总结
The purpose of this study is to determine if a home based occupational therapy is effective in the treatment of dementia.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia (according to DSM-IV TR)
- •A score 26 to 12 on the MMSE
- •Must be 55 or older
- •Patient is living at home or therapeutical flat sharing
- •Primary care giver at least 2 days / week available at home
- •Written informed consent from patient and care giver
- •German as dominant language
排除标准
- •Other dementia (p.e. frontotemporal dementia, dementia with Lewy Bodies, Creutzfeldt-Jakob disease, Parkinson's disease or atypical Parkinson's syndromes
- •Dementia with relevant displaying behavioural problems (neuropsychiatric Inventory; NPI, Subscore ≥ 8)
- •Depressive episodes (Geriatric Depression Scale, GDS (short version) ≥ 6)
- •Mental disability
- •Home Based Occupational Therapy for Dementia within the last 6 months
- •Impairment of visual and/or acoustic cognition which does not allow Occupational Therapy
- •Apoplexy with movement disorders which does not allow Occupational Therapy
- •Severe physical/systemic illnesses (cardio-pulmonal, Hematological or metabolic) which do not allow participating
- •Recent history of addictive disorder
- •Intermittent intake of depressant medication, that likely causes an impairment of cognitive performance during the trial
- •Participation in another clinical trial
研究组 & 干预措施
A
Experimental
optimized home based occupational therapy including:
- diagnostic assessment
- patient-centered definition of targets involving the care giver
- occupational therapy
干预措施: Occupational Therapy (Behavioral)
B
No Intervention
treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without optimized occupational therapy
结局指标
主要结局
Alzheimer's Disease Cooperative Study/Activities of Daily Living
时间窗: 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group)
次要结局
- - for patients: cognitive performance, displaying behavioural problems, satisfaction with occupational therapy, costs of occupational therapy - for family care givers: burden, medical condition, life-satisfaction(2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group))
研究者
Dr. Matthias Schützwohl
PD Dr.
Technische Universität Dresden
研究点 (3)
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