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之前的临床试验的发现基础上，该试验证明了在初级保健实践中对老年阿尔茨海默病患者进行协作护理的有效性。在之前的试验中，我们证明了在一年的时间里，指导级别的医疗护理提高了护理质量，改善了患者及其护理人员的行为和心理症状。然而，尽管在神经精神量表评分上发现了研究组之间的显著差异，但在功能衰退方面，我们没有发现组间的显著差异。两个研究组在18个月的时间里都经历了显著的功能下降。目前的研究建议测试一种以家庭为基础的干预措施，专门用于减缓老年痴呆症患者的功能衰退速度。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，这些研究证明了以家庭为基础的职业治疗干预对老年痴呆症患者的短期疗效。这些试验表明，患有痴呆症（包括阿尔茨海默病）的老年人既可以参与在家提供的基于职业治疗的干预措施，也可以从中受益。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和接受最佳实践初级保健加家庭职业治疗干预的干预组，以改善老年阿尔茨海默病患者的功能。我们将检验干预组阿尔茨海默病患者两年后与最佳实践初级保健对照组相比功能改善的主要假设。

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. PUBLIC HEALTH RELEVANCE: More than 4 million Americans suffer from Alzheimer's disease and even under optimistic scenarios of the effectiveness of new treatments, this number will triple over the next few decades. For this reason, effective approaches to providing longitudinal care in the community for this burgeoning population are urgently needed.