Alzheimer's Disease Multiple Intervention Trial - ADMIT

描述(由申请人提供)：这项拟议的研究建立在我们之前的一项临床试验的基础上，该试验证明了初级保健实践中护理的阿尔茨海默病老年人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改善了患者及其照顾者的护理质量并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病学问卷得分上存在显著差异，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基于家庭的干预措施，旨在减缓患有阿尔茨海默病的老年人的功能衰退速度。除了我们过去的研究之外，这项研究还建立在最近报道的研究的基础上，这些研究证明了以家庭为基础的职业治疗干预对患有痴呆症的老年人的短期疗效。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家庭提供的基于职业治疗的干预措施。这项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以家庭为基础的职业治疗干预的干预组，来改善阿尔茨海默病老年患者的功能。我们将检验基本假设，即与最佳实践的初级保健控制组相比，干预组中的阿尔茨海默病患者在两年内功能将有所改善。 与公共卫生相关：超过400万美国人患有阿尔茨海默氏症，即使在新疗法的有效性乐观的情况下，这一数字在未来几十年也将增加两倍。为此，迫切需要采取有效的方法，在社区内为这一迅速增长的人口提供纵向护理。

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.