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1500万家庭护理人员（CG）。该疾病的一个标志和痴呆症护理中最重要的挑战之一是神经精神症状（NPD），其中激越是最致残和最频繁发生的。它与增加的医疗保健费用，降低生活质量，增加照顾者的负担，疾病加速和养老院安置有关。治疗通常涉及药物;然而，这些药物充其量是适度有效的，具有严重的风险，包括死亡率，并且可能不会减少家庭的痛苦。最近发表的立场声明，从医疗机构建议非药物策略作为一线治疗。然而，激动的非药物策略仍然研究不足。我们提出了一项III期疗效试验，以测试一种新的8次会议以患者为中心的干预，定制活动计划（CAP）。我们将使用随机化两组平行设计对250名痴呆（PwD）患者及其CG（二人组）进行CAP测试，这些患者将被随机分配至CAP或同等家庭关注和社会接触的对照干预。CAP评估残疾人保留的能力、缺陷、以前的角色、习惯、兴趣和家庭环境，从中制定活动以匹配残疾人概况。家庭接受培训，以实施活动，并修改他们的未来下降。60个二联体的初步试验阶段显示，激越有临床意义和统计学显著性降低，无不良反应。我们的主要研究目的是评估CAP在3个月时对激越的影响（假设：与对照干预条件相比，CAP中的PwD将具有较低的临床医生评定的激越。三个次要目标评估：1）CAP对PwD患者躁动和生活质量的6个月影响（假设：与对照干预中的PwD相比，CAP中的PwD将在6个月时表现出较低的临床医生评定的子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健康的即时影响，以及提供护理所花费的时间（假设：与对照干预（3个月和6个月）相比，接受CAP的CG将报告增强的幸福感和更少的时间延迟;和3）履约协助方案的成本效益，表现为以减少共同体负担和愿意为减轻负担支付费用的形式实现的增量成本成果（3个月和6个月;假设：与每次测试时的对照干预相比，CAP将具有成本效益）。五个探索性目标将评估对精神药物使用和其他麻烦行为的治疗效果，如果效果因认知状态而异，如果接受CAP的CG使用活动6个月，频率如何，如何花费获得的时间，以及治疗和活动使用的频率/持续时间是否影响结局。如果证明有效和成本效益，CAP有可能改变临床实践，提供一个行之有效的非药物治疗的PwD在家里的搅拌。本试验解决了关键的临床需求和公共卫生优先事项 最近的立法活动。

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.