Palliative Care for Persons with Late-stage Alzheimer's and Related Dementias and their Caregivers a Randomized Clinical Trial

摘要 阿尔茨海默病和相关痴呆症（ADRD）影响560万美国人， 每年花费超过1570亿美元。家庭照顾者经历了非凡的身体， 情绪和经济压力被认为是西班牙裔/拉丁裔的人是其他人的1.5倍。 发展ADRD。三分之一的西班牙裔/拉丁裔照顾者报告说，偏见，信息不足， 实际障碍限制了获得ADRD专科护理的机会。急性病的住院治疗是 常见于晚期ADRD，也为痴呆特异性 姑息治疗，以解决痛苦和减少繁琐的治疗，因为72%的医院， 都有姑息治疗团队痴呆症特异性姑息治疗的证据很少， 文化适应以满足西班牙裔/拉丁裔家庭的需要是一个主要的研究空白。 我们的研究团队正在进行ADRD-PC研究（R 01 AG 065394），这是一项多中心研究， 第二阶段疗效临床试验，这是痴呆姑息治疗的第一个严格测试 干预患有晚期痴呆症的人和他们的照顾者在一个 急性病住院治疗。将二人组随机分配至ADRD-PC干预组（专业 姑息治疗+结构化护理人员教育+过渡性护理）或对照（教育 材料上的痴呆症（痴呆）武器，并随访60天后出院。招生 于2021年11月在所有站点开始，并在时间轴上。因此，我们处于独特的地位， 及时利用研究基础设施来弥补这一差距。 我们的研究目标是在文化上调整ADRD-PC干预，并进行一项研究。 适应性ADRD-PC干预晚期患者的初步可行性临床试验 自认为是西班牙裔/拉丁裔的ADRD及其家庭照顾者。我们会进行 知情者对研究材料和过程的调整（目标1），入组n=50 晚期ADRD的西班牙裔/拉丁裔成年人及其家庭照顾者的住院二人组。 我们实现这一目标的具体目标是：目标1：适应和实施ADRD-PC 学习在文化和语言上适合这一人群的材料， 西班牙裔/拉丁裔利益相关者小组。目标2：确定可行性、可接受性和 ADRD-PC干预对n= 50例西班牙裔/拉丁裔二人组的初步疗效， 晚期痴呆症的临床试验。 影响：ADRD-PC临床试验的补充有可能产生积极影响 在ADRD护理和研究中存在的健康差距， 患有晚期痴呆症的拉丁美洲人及其家庭照顾者。

ABSTRACT Alzheimer’s disease and related dementias (ADRD) affect 5.6 million Americans at an annual cost of over $157 billion. Family caregivers experience extraordinary physical, emotional and financial strain. People who identify as Hispanic / Latino are 1.5 times as likely to develop ADRD. One in 3 Hispanic / Latino caregivers report that bias, poor information and practical barriers limit access to specialty ADRD care. Hospitalizations for acute illnesses are common in late-stage ADRD, and also present a unique opportunity for dementia-specific palliative care to address suffering and reduce burdensome treatments, since 72% of hospitals have palliative care teams. Evidence for dementia-specific palliative care is rare, and its cultural adaptation to meet the needs of Hispanic / Latino families is a major research gap. Our research team is conducting the ADRD-PC study (R01AG065394), a multi-site Stage II efficacy clinical trial that is the first rigorous test of a dementia palliative care intervention. People with late-stage dementia and their caregivers are enrolled during a hospitalization for acute illness. Dyads are randomized to the ADRD-PC intervention (specialty palliative care + structured caregiver education + transitional care) or control (educational materials on dementia caregiving) arms and followed for 60-days post discharge. Enrollment began in all sites in November 2021, and is on timeline. We are thus uniquely positioned to leverage research infrastructure in a timely way to address this gap. Our research objective is to culturally tailor the ADRD-PC intervention, and conduct a pilot feasibility clinical trial of the adapted ADRD-PC intervention for people with late-stage ADRD who self-identify as Hispanic / Latino and their family caregivers. We will conduct stakeholder-informed adaptation of study materials and processes (Aim 1), and enroll n=50 hospitalized dyads of Hispanic / Latino adults with late-stage ADRD and their family caregivers. Our Specific Aims to achieve this objective are: Aim 1: To adapt and implement ADRD-PC study materials that are culturally and linguistically appropriate for this population, guided by a panel of Hispanic / Latino stakeholders. Aim 2: To determine the feasibility, acceptability and preliminary efficacy of the ADRD-PC intervention for n= 50 Hispanic / Latino dyads living with late-stage dementia in a pilot randomized clinical trial. IMPACT: This supplement to the ADRD-PC clinical trial has the potential to positively impact existing health disparities in ADRD care and research for people who identify as Hispanic / Latino with late-stage dementia and their family caregivers.