Alzheimer's Disease Multiple Intervention Trial - ADMIT

描述（由申请人提供）：拟议的研究建立在我们以前的临床试验的结果，该试验证明了在初级保健实践中护理老年阿尔茨海默病患者的协作护理的有效性。在之前的试验中，我们证明了指南水平的医疗护理在一年内提高了患者及其护理人员的护理质量，改善了行为和心理症状。然而，尽管发现研究组之间在神经精神量表评分上存在显著差异，但我们没有发现两组之间在功能下降方面存在显著差异。两个研究组在18个月内都经历了功能的显著下降。目前的研究建议测试一种专门设计用于减缓老年痴呆症患者功能下降速度的家庭干预措施。除了建立在我们过去的研究基础上，这项研究还建立在最近报道的研究基础上，这些研究证明了在老年痴呆症患者中进行家庭职业治疗干预的短期疗效。这些试验表明，患有痴呆症（包括阿尔茨海默病）的老年人可以参与并受益于在家中提供的基于职业治疗的干预措施。本研究的具体目的是进行一项为期两年的随机对照临床试验，通过比较接受最佳实践初级保健的对照组与接受最佳实践初级保健的干预组以及以家庭为基础的职业治疗干预，来改善老年痴呆症患者的功能。我们将检验主要假设，即与最佳实践初级保健对照组相比，干预组中的阿尔茨海默病受试者在两年内的功能有所改善。

DESCRIPTION (provided by applicant): The proposed study builds on our findings from a previous clinical trial that demonstrated the effectiveness of collaborative care for older adults with Alzheimer's disease cared for in primary care practices. In the prior trial, we demonstrated that guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over one year among patients and their caregivers. However, despite finding significant differences among study groups on Neuropsychiatric Inventory scores, we did not find a significant difference between groups in functional decline. Both study groups experienced a significant decline in function over 18 months. The current study proposes to test a home-based intervention specifically designed to slow the rate of functional decline among older adults with Alzheimer's disease. In addition to building on our past research, the study also builds from recently reported research which demonstrated the short-term efficacy of home-based occupational therapy interventions among older adults with dementia. These trials show that older adults with dementia, including Alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home. The specific aim of this study is to conduct a two-year, randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention. We will test the primary hypothesis that subjects with Alzheimer's disease in the intervention group will have improved function at two years compared with the best practice primary care control group.