I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer's-related Symptoms for Caregivers and Patients

I-CARE 2 RCT：移动远程医疗可减少护理人员和患者的阿尔茨海默病相关症状

• 批准号: 10505463
• 负责人: MALAZ BOUSTANI
• 金额: $ 80.16万
• 依托单位: TRUSTEES OF INDIANA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10505463
• 关键词: AIDS dementia; Affect; African American; Aggressive behavior; Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; Base of the Brain; Behavior; Behavior Therapy; Behavioral Model; Behavioral Symptoms; Black race; Brain; COVID-19; Caregiver Burden; Caregivers; Caring; Clinic; Communities; Consent; Data; Dementia; Distress; Education; Emergency department visit; Enrollment; Equipment and supply inventories; Evidence based intervention; Foundations; Funding; Goals; Health; Hospitals; Indiana; Intervention; Intervention Studies; Long-Term Care; Measures; Mental Depression; Modeling; National Institute on Aging; Pain; Patient Transfer; Patients; Persons; Pilot Projects; Public Health; Publishing; Quality of life; Questionnaires; Race; Randomized; Randomized Clinical Trials; Sampling; Secure; Seminal; Sleep disturbances; Source; Symptoms; Technology; Testing; Time; United States National Institutes of Health; acute care; aging brain; attentional control; base; cost; dementia care; depressive symptoms; effectiveness research; evidence base; experience; feasibility trial; follow-up; implementation research; informal caregiver; informal support; innovation; mobile application; mobile computing; neuropsychiatry; pilot trial; primary endpoint; primary outcome; programs; psychological symptom; remote health care; remote intervention; sex; systematic review; telehealth; therapy development; user centered design

PROJECT SUMMARY/ABSTRACT Among patients with Alzheimer’s disease and related dementias (ADRD) and their informal caregivers, behavioral and psychological symptoms of dementia (BPSD) are a critical need requiring scalable, evidence- based intervention. As many as 97% of patients with ADRD will ultimately experience BPSD, yet they are poorly managed and remain the top source of caregiver burden. Technology may be a solution; indeed, the National Institute on Aging and others demand mobile technology-based behavioral interventions to support informal caregivers of patients with ADRD. Systematic reviews and market analyses of existing mobile technologies or “apps” demonstrate promise but critical limitations: lack of scientific foundation and evidence of efficacy; missing features and functions; and low to moderate quality. Our interdisciplinary team followed the NIH Stage Model for Behavioral Intervention Development to: 1) establish an evidence-based intervention model for BPSD management (NIH Model Stage 0); 2) apply user- centered design to embed this evidence-based model into Brain CareNotes, a mobile telehealth app (NIH Model Stage IA); and 3) conduct I-CARE, a set-up pilot study that established the feasibility and potential efficacy of Brain CareNotes (NIH Model Stage IB-II). The pilot study demonstrated that at the 6-month endpoint, Brain CareNotes reduced informal caregiver burden and reduced BPSD. Here we propose I-CARE 2, a Stage III randomized clinical trial (RCT), as the next step in the NIH Stage Model. I-CARE 2 will evaluate the real-world efficacy of Brain CareNotes on the primary outcomes of informal caregiver burden and BPSD at 12 months. We plan to enroll N=160 community-dwelling, English-speaking informal caregivers of patients with ADRD, across the state of Indiana. Informal caregivers will be randomized (stratified by sex and race) to 12 months of Brain CareNotes (n=80) or Attention Control education-only app (Dementia Guide Expert) (n=80). Follow-up will occur at 12 months, with additional assessments at 6 months to test for early effects. We will test primary hypotheses that, relative to Attention Control, informal caregivers randomized to Brain CareNotes will have: (H1) lower caregiver burden as measured by the Caregiver Distress sub-score on the Neuropsychiatric Inventory (NPI); and (H2) lower BPSD as measured by the NPI Total Score. Secondary hypotheses will be tested comparing groups on (H3) depressive symptoms as measured by the Patient Health Questionnaire (PHQ)-9 and (H4) acute care utilization as determined by the number of hospital and emergency room visits captured in the statewide regional health information exchange. If successful, this NIH Stage III RCT study will yield evidence of the efficacy of a highly scalable non- pharmacological intervention for BPSD, one of the most burdensome aspects of ADRD care. If our caregiver- facing mobile telehealth app is efficacious in real-world settings, subsequent Stage IV-V effectiveness and implementation research efforts can help relieve the critical public health burden of ADRD.

项目概要/摘要 在阿尔茨海默病和相关痴呆症 (ADRD) 患者及其非正式护理人员中， 痴呆症的行为和心理症状（BPSD）是一个关键需求，需要可扩展的证据 为基础的干预。多达 97% 的 ADRD 患者最终会经历 BPSD，但他们 管理不善，仍然是护理人员负担的首要来源。技术可能是一个解决方案；确实， 国家老龄化研究所和其他机构要求基于移动技术的行为干预措施来支持 ADRD 患者的非正式护理人员。对现有移动设备的系统回顾和市场分析 技术或“应用程序”显示出前景，但存在严重局限性：缺乏科学基础和证据 功效;缺少特性和功能；以及低到中等的质量。 我们的跨学科团队遵循 NIH 行为干预开发阶段模型： 1）建立BPSD管理循证干预模型（NIH模型0阶段）； 2）申请用户- 以证据为中心的设计将这种基于证据的模型嵌入到 Brain CareNotes 中，这是一款移动远程医疗应用程序 (NIH 模型阶段IA)； 3) 进行 I-CARE，这是一项初步研究，确定了可行性和潜力 Brain CareNotes（NIH 模型 IB-II 期）的功效。试点研究表明，在 6 个月的时间里 终点，Brain CareNotes 减少了非正式护理人员的负担并减少了 BPSD。 在此，我们提出 I-CARE 2，一项 III 期随机临床试验 (RCT)，作为 NIH 阶段的下一步 模型。 I-CARE 2 将评估 Brain CareNotes 对非正式训练主要结果的现实效果 12 个月时的照顾者负担和 BPSD。我们计划招募 N=160 社区居民、讲英语的人 印第安纳州各地 ADRD 患者的非正式护理人员。非正式护理人员将被随机分配 （按性别和种族分层）至 12 个月的 Brain CareNotes (n=80) 或注意力控制教育应用程序 （痴呆症指南专家）（n=80）。随访将在 12 个月时进行，并在 6 个月时进行额外评估 测试早期效果。我们将测试主要假设，即相对于注意力控制，非正式护理人员 随机分配到 Brain CareNotes 将具有： (H1) 通过看护者困境衡量的看护者负担较低 神经精神量表 (NPI) 的子分数； (H2) 根据 NPI 总分衡量，BPSD 较低。 将测试次要假设，比较各组的 (H3) 抑郁症状，如通过 患者健康问卷 (PHQ)-9 和 (H4) 急性护理利用率（根据医院数量确定） 全州区域卫生信息交换中记录的急诊室就诊情况。 如果成功，这项 NIH III 期随机对照试验研究将提供高度可扩展的非 BPSD 的药物干预是 ADRD 护理中最繁重的方面之一。如果我们的看护者—— 面向移动远程医疗应用程序在现实环境中有效，随后的 IV-V 阶段有效性和 实施研究工作可以帮助减轻 ADRD 带来的重大公共卫生负担。