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

描述(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转的神经退行性疾病，也影响到近1500万家庭照顾者(CG)。这种疾病的一个特点，也是痴呆症治疗中最大的挑战之一是神经精神症状(NPS)，其中激动是最使人残疾和最常见的。它与医疗保健成本增加、生活质量下降、照顾者负担加重、疾病加速和养老院安置有关。治疗通常涉及药物；然而，这些充其量是适度有效的，存在包括死亡在内的严重风险，并且可能不会减少家庭痛苦。医疗组织最近发表的立场声明建议将非药物策略作为一线治疗。然而，对于激怒的非药理学策略仍未得到充分研究。我们提出了一项第三阶段疗效试验，以测试一种新的以患者为中心的8个疗程的干预措施，定制活动计划(CAP)。我们将采用随机两组平行设计对250名痴呆症患者(PWD)和他们的CG(DYAD)进行CAP测试，他们将被随机分配到CAP组或同等家庭关注和社交接触的对照干预组。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，以开展与残疾人概况相匹配的活动。家庭接受培训，以实施活动并对其进行修改，以应对未来的衰落。60个二联体的试验阶段在临床上有意义，在统计学上显著减少了激越，没有不良影响。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具有更低的临床医生分级激越。三个次级目标评估：1)CAP对PWD患者焦虑和生活质量的6个月影响(假设：与对照干预中的PWD相比，CAP组的PWD在6个月时表现出更低的临床医生评分和更高的生活质量)；2)CAP在3个月和6个月时对CG幸福感和提供护理所花费的时间的即时影响(假设：与对照干预相比(3和6个月)，接受CAP的CGS将报告更好的幸福感和更少的护理时间；3)CAP的成本效益表现为以CG减负和愿意为减负买单的形式实现的增量成本结果(3和6个月)；假设：与每个测试场合的对照干预相比，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，如果效果因认知状况而异，接受CAP活动的CGs是否在6个月内使用活动，以什么频率使用，获得的时间是如何花费的，以及治疗频率/持续时间和活动使用是否影响结果。如果CAP被证明是有效的和具有成本效益的，它有可能改变临床实践，为家庭中的Pwds激动症提供一种经过验证的非药物治疗方法。这项试验解决了一个关键的临床需求和公共卫生优先事项 由最近的立法活动确定的。

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.