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

项目概要/摘要 在阿尔茨海默病和相关痴呆症（ADRD）患者及其非正式照顾者中， 痴呆症的行为和心理症状（BPSD）是一个关键的需求，需要可扩展的，证据， 基于干预。多达97%的ADRD患者最终会经历BPSD，但他们 管理不善，仍然是照顾者负担的首要来源。技术可能是一个解决方案;事实上， 国家老龄化研究所和其他机构需要基于移动的技术的行为干预来支持 ADRD患者的非正式护理人员。对现有移动的 技术或“应用程序”显示出希望，但存在严重的局限性：缺乏科学基础和证据， 功效;缺少特征和功能;低至中等质量。 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循证干预模式（NIH Model Stage 0）; 2）应用用户- 以证据为基础的模型嵌入到大脑护理笔记，一个移动的远程医疗应用程序（NIH 模型阶段IA）;以及3）进行I-CARE，这是一项初步试验研究，确定了可行性和潜力 Brain CareNotes（NIH Model Stage IB-II）初步研究表明，在6个月 终点，Brain CareNotes减少了非正式护理人员的负担，并降低了BPSD。 在这里，我们建议I-CARE 2，一个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对非正式研究的主要结局的真实有效性。 护理者负担和12个月时的BPSD。我们计划招募N=160名社区居民，讲英语 在印第安纳州，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）或仅限注意力控制教育的应用程序 （痴呆症指南专家）（n=80）。将在12个月时进行随访，并在6个月时进行额外评估 来测试早期效应我们将测试的主要假设，相对于注意力控制，非正式照顾者， 随机分配至Brain CareNotes组的患者将具有：（H1）通过护理者痛苦测量的护理者负担较低 神经精神量表（NPI）的分项评分;和（H2）通过NPI总评分测量的较低BPSD。 将对次要假设进行检验，比较各组的（H3）抑郁症状， 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 以及全州区域健康信息交换中记录的急诊室就诊情况。 如果成功的话，这项NIH III期RCT研究将提供证据证明一种高度可扩展的非- 药物干预BPSD，ADRD护理的最繁重的方面之一。如果我们的看护者- 面向移动的远程医疗应用程序在现实环境中是有效的，随后的第IV-V阶段有效性和 实施研究工作可以帮助减轻ADRD的关键公共卫生负担。

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.