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

减少痴呆症患者在家中的躁动：定制活动试验

• 批准号: 9161118
• 负责人: Laura N. Gitlin
• 金额: $ 16.2万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-11-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9161118
• 关键词: Acceleration; Address; Adverse effects; Affect; Aggressive behavior; Agitation; Alzheimer' s Disease; American; Antidepressive Agents; Antipsychotic Agents; Area; Behavior; Behavioral; Bioethics; Caregiver Burden; Caregivers; Caring; Cholinesterase Inhibitors; Clinical; Cognitive; Communities; Dementia; Diagnosis; Disease; Distress; Dose; Elderly; Epidemic; Equipment and supply inventories; Family; Family Caregiver; Family member; Frequencies; Fright; Funding; Future; Guidelines; Habits; Health Care Costs; Health Care Reform; Home environment; Individual; Intervention; Life; Malignant Neoplasms; Medical; Medication Management; National Institute of Mental Health; Nerve Degeneration; Nursing Homes; Outcome; Patients; Pharmaceutical Preparations; Phase; Positioning Attribute; Prevalence; Public Health; Quality of life; Randomized; Reporting; Resistance; Risk; Role; Severities; Testing; Time; Training; Translations; United States; Universities; adverse outcome; base; burden of illness; caregiving; clinical practice; community living; cost; cost effective; cost effectiveness; daily functioning; dementia care; design; disability burden; efficacy trial; improved; interest; mortality; neuropsychiatric symptom; neuropsychiatry; novel; programs; public health priorities; skill acquisition; social; social attention; standard of care; treatment as usual; treatment duration; treatment effect; willingness to pay

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.

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，这是一种进行性且不可逆转的神经退行性疾病，也影响着近 1500 万家庭护理人员 (CG)。该疾病的一个标志，也是痴呆症护理中最重大的挑战之一是神经精神症状（NPS），其中激越是最严重且最常见的。它与医疗保健成本增加、生活质量下降、护理人员负担加重、疾病加速和疗养院安置有关。治疗通常涉及药物治疗；然而，这些措施最多只能起到一定的效果，而且会带来包括死亡在内的严重风险，并且可能无法减少家庭的痛苦。医疗组织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，针对躁动的非药物策略仍未得到充分研究。我们提出了一项 III 期疗效试验，以测试一种新颖的以患者为中心的 8 疗程干预措施，即定制活动计划 (CAP)。我们将使用随机两组平行设计来测试 CAP，该设计由 250 名痴呆症患者 (PwD) 及其 CG（二人组）组成，他们将被随机分配到 CAP 组或同等家庭注意力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，并据此制定活动以匹配残疾人的概况。家庭接受培训以实施活动并针对未来的衰退进行修改。 60 组试验的试验阶段显示出具有临床意义和统计学意义的躁动减少，且无不良影响。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 中的残疾人临床医生评定的躁动程度较低。三个次要目标评估：1）CAP 对躁动和质量的 6 个月影响残疾人的生活质量（假设：与对照干预中的残疾人相比，CAP 中的残疾人将在 6 个月时表现出较低的临床医生评定的子量表严重性评分以及更好的生活质量）； 2) 3 个月和 6 个月时 CAP 对 CG 健康状况以及提供护理所花费的时间的直接影响（假设：与对照干预措施（3 个月和 6 个月）相比，接受 CAP 的 CG 报告健康状况得到改善，护理时间更少；以及 3) 成本CAP 的有效性表示为以 CG 负担减轻和为减轻负担付费的意愿的形式实现的增量成本成果（3 个月和 6 个月；假设：与 CAP 相比，CAP 具有成本效益）在每个测试场合进行控制干预）。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，影响是否因认知状态而异，CG是否接受 CAP 使用活动 6 个月，频率如何，获得的时间如何花费，以及治疗的频率/持续时间活动的使用会影响结果。如果被证明有效且具有成本效益，CAP 有可能通过为家庭残疾人躁动提供经过验证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优先事项 最近的立法活动确定了这一点。