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: 10812844
• 负责人: MALAZ BOUSTANI
• 金额: $ 4.36万
• 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/10812844
• 关键词: Affect; Alzheimer' s Disease; Alzheimer' s disease caregiver; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Behavior Therapy; Behavioral Model; Behavioral Symptoms; Brain; Caregiver Burden; Caregivers; Caring; Communities; Data; Dementia; Distress; Education; Emergency department visit; Enrollment; Equipment and supply inventories; Evidence based intervention; Foundations; Health; Health Technology; Hospitals; Indiana; Marketing; Measures; Modeling; National Institute on Aging; Patients; Pilot Projects; Public Health; Questionnaires; Race; Randomized; Sampling; Source; Symptoms; Technology; Testing; Time; United States National Institutes of Health; acute care; attentional control; brain based; dementia care; depressive symptoms; effectiveness research; evidence base; experience; follow-up; implementation research; informal caregiver; informal support; mobile computing; neuropsychiatry; primary outcome; psychological symptom; randomized, clinical trials; 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.

项目摘要/摘要 在阿尔茨海默病和相关痴呆症(ADRD)患者及其非正式照顾者中， 痴呆症的行为和心理症状(BPSD)是一种迫切需要可扩展的证据- 以干预为基础。多达97%的ADRD患者最终将经历bpsd，但他们 管理不善，仍然是照顾者负担的最大来源。技术可能是一种解决方案；事实上， 国家老龄研究所和其他机构要求基于移动技术的行为干预来支持 ADRD患者的非正式照顾者。对现有移动电话的系统评估和市场分析 技术或“应用程序”展示了前景，但存在关键限制：缺乏科学基础和证据 药效差；缺少特性和功能；质量低到中等。 我们的跨学科团队遵循NIH行为干预发展阶段模型： 1)建立BPSD管理的循证干预模型(NIH模型第0阶段)；2)应用用户- 以中心为中心的设计，将这种基于证据的模型嵌入移动远程医疗应用程序Brain CareNotes(NIH 模型阶段IA)；以及3)进行I-CARE，这是一项初步研究，确定了 脑部护理笔记的疗效(NIH模型阶段IB-II)。试点研究表明，在6个月内 终点，Brain CareNotes减少了非正式照顾者的负担，并减少了BPSD。 在这里，我们建议I-CARE 2，一个第三阶段的随机临床试验(RCT)，作为NIH阶段的下一步 模特。I-CARE 2将评估Brain Care2的实际疗效 12个月时照顾者负担和BPSD。我们计划招收N=160名讲英语的社区居民 印第安纳州ADRD患者的非正式照顾者。非正式照顾者将被随机分配 (按性别和种族分层)至12个月的Brain CareNote(n=80)或仅限注意力控制教育的应用程序 (痴呆指导专家)(n=80)。将在12个月后进行跟踪，6个月后再进行评估 以测试早期效果。我们将检验主要假设，相对于注意力控制，非正式照顾者 随机到大脑的护理笔记将具有：(H1)照顾者痛苦测量的较低照顾者负担 神经精神病量表(NPI)的分项得分；以及(H2)通过NPI总分衡量的较低的BPSD。 第二个假设将通过比较(H3)抑郁症状组进行检验，这些症状由 患者健康问卷(PHQ)-9和(H4)根据医院数量确定的急性护理利用情况 以及在全州范围的区域卫生信息交换中捕获的急诊室就诊。 如果成功，这项NIH III阶段RCT研究将产生高度可扩展的非 对BPSD的药物干预，这是ADRD护理中最繁重的方面之一。如果我们的照顾者- 面向移动远程医疗APP在现实世界设置中有效，后续阶段IV-V有效性和 实施研究工作有助于减轻ADRD严重的公共卫生负担。