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

晚期阿尔茨海默病和相关痴呆症患者及其护理人员的姑息治疗随机临床试验

• 批准号: 10631651
• 负责人: LAURA C HANSON
• 金额: $ 25.77万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-10 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10631651
• 关键词: Acute; Address; Administrative Supplement; Adult; Affect; Alzheimer' s disease related dementia; American; Attention; Back; Caregivers; Caring; Clinical; Clinical Trials; Consent; Dementia; Dementia caregivers; Dependence; Distress; Educational Materials; Eligibility Determination; Emotional; Enrollment; Ensure; Face; Family; Family Caregiver; Financial Hardship; Fracture; Future; Goals; Grant; Hispanic; Hospitalization; Hospitals; Infection; Infrastructure; Intervention; Interview; Language; Latino; Latino Population; Linguistics; Medical; Methods; Multi-Institutional Clinical Trial; Outcome; Outcome Assessment; Outcome Measure; Palliative Care; Patient-Focused Outcomes; Patients; Persons; Population; Positioning Attribute; Procedures; Process; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research; Research Infrastructure; Research Personnel; Site; Structure; Symptoms; Testing; Time; TimeLine; Training; Translating; Work; arm; behavioral clinical trial; caregiver education; cost; dementia care; dementia caregiving; effectiveness clinical trial; efficacy clinical trial; experience; falls; feeding; health disparity; health equity; health goals; health literacy; improved; improved outcome; literacy; medical complication; medical specialties; operation; palliative; preference; recruit; reduce symptoms; trend

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.

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， 在一项试点随机临床试验中治疗晚期痴呆症。 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。