Reducing Agitation in Dementia Patients at Home: The Customized Activity Trial

描述（由申请人提供）：超过500万美国人患有阿尔茨海默病或相关的痴呆症，这是一种进行性和不可逆的神经退行性疾病，也影响了近1500万家庭照顾者（CG）。该疾病的一个标志和痴呆症护理中最重大的挑战之一是神经精神症状（NPS），其中躁动是最致残和最频繁发生的。它与卫生保健费用增加、生活质量下降、护理人员负担加重、疾病加速和养老院安置有关。治疗通常涉及药物制剂；然而，这些充其量只是适度有效，存在包括死亡在内的严重风险，并且可能无法减少家庭的痛苦。医疗机构最近发布的立场声明建议将非药物策略作为一线治疗。然而，躁动的非药物治疗策略仍未得到充分研究。我们建议进行一项III期疗效试验，以测试一种新的8期以患者为中心的干预措施，即定制活动计划（CAP）。我们将使用随机两组平行设计测试250名痴呆症患者（PwD）和他们的CGs（二人组），他们将被随机分配到CAP或同等的家庭关注和社会接触的控制干预。评估残疾人士保留的能力、缺陷、以前的角色、习惯、兴趣和家庭环境，以发展符合残疾人士特点的活动。家庭接受培训，以实施活动并对其进行修改，以应对未来的衰退。60对夫妇的试点阶段显示出具有临床意义和统计学意义的躁动减少，没有不良反应。我们的主要研究目的是评估CAP在3个月时对躁动的影响(假设：与对照干预条件相比，CAP中的PwD会有更低的临床医生评价的躁动。三个次要目标评估：1)6个月CAP对PwD患者躁动和生活质量的影响（假设：与对照干预的PwD相比，CAP干预的PwD患者在6个月时表现出较低的临床评定亚量表严重程度评分和更好的生活质量）；2) CAP在3个月和6个月时对CG幸福感和护理时间的直接影响(假设：与对照组干预（3个月和6个月）相比，接受CAP的CG会报告幸福感增强，护理时间减少；3) CAP的成本效益表示为以CG负担减轻和为负担减轻支付意愿的形式实现的增量成本结果（3个月和6个月；假设：在每个测试场合，CAP与对照干预相比将具有成本效益）。五个探索性目标将评估治疗对精神药物使用和其他麻烦行为的效果，如果效果因认知状态而异，如果cg接受CAP使用活动6个月，频率是多少，获得的时间是如何花费的，以及频率/持续时间的治疗和活动的使用是否影响结果。如果被证明有效且具有成本效益，CAP有可能通过提供一种经证实的在家治疗残疾患者躁动的非药物治疗来改变临床实践。该试验解决了关键的临床需求和公共卫生重点

DESCRIPTION (provided by applicant): Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and frequently occurring. It is associated with increased health care costs, reduced life quality, heightened caregiver burden, disease acceleration and nursing home placement. Treatment typically involves pharmacologic agents; however, these are at best modestly effective, carry serious risks including mortality, and may not reduce family distress. Recently issued position statements from medical organizations suggest nonpharmacologic strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation remain understudied. We propose a Phase III efficacy trial to test a novel 8-session patient-centric intervention, the Customized Activity Program (CAP). We will test CAP using a randomized two- group parallel design of 250 people with dementia (PwD) and their CGs (dyads) who will be randomly assigned to CAP or a control intervention of equivalent in-home attention and social contact. CAP assesses PwDs' preserved capabilities, deficits, previous roles, habits, interests and home environment from which activities are developed to match PwD profiles. Families are trained to implement activities and modify them for future decline. A pilot phase with 60 dyads showed clinically meaningful and statistically significant reductions in agitation, with no adverse effects. Our primary study aim evaluates the effect of CAP at 3 months on agitation (Hypothesis: PwD in CAP will have lower clinician rated agitation compared to the control intervention condition. Three secondary aims evaluate: 1) 6-month effects of CAP on agitation and quality of life in PwD (Hypothesis: PwD in CAP will manifest lower clinician rated subscale severity scores at 6 months and better quality of life compared to PwD in the control intervention); 2) Immediate effects of CAP at 3 and 6 months on CG wellbeing, and time spent providing care (Hypothesis: CGs receiving CAP will report enhanced wellbeing and less time caregiving compared to the control intervention (3 and 6 months); and 3) Cost effectiveness of CAP expressed as an incremental cost outcome achieved in the form of CG burden reductions and willingness to pay for burden reductions (3 and 6 months; Hypothesis: CAP will be cost effective compared to the control intervention at each test occasion). Five exploratory aims will evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if effects differ by cognitive status, if CGs receiving CAP use activities a 6 months and with what frequency, how time gained is spent, and if frequency/duration of treatment and activity use affects outcomes. If proven efficacious and cost effective, CAP has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial addresses a critical clinical need and public health priority identified by recent legislative activity.