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

基本信息

批准号：
10893170
负责人：
MALAZ BOUSTANI
金额：
$ 17.43万
依托单位：
TRUSTEES OF INDIANA UNIVERSITY
依托单位国家：
美国
项目类别：
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/10893170
关键词：
Affect African American Aggressive behavior Agitation Alzheimer&apos s Disease Alzheimer&apos s disease caregiver Alzheimer&apos s disease patient Alzheimer&apos s disease related dementia 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 Health Technology Hospitals Indiana Intervention Intervention Studies Long-Term Care Marketing Measures Mental Depression Modeling National Institute on Aging Pain Patient Transfer Patients Pilot Projects Public Health Publishing Quality of life Questionnaires Race Randomized Sampling Secure Seminal Sleep disturbances Source Symptoms Technology Testing Time United States National Institutes of Health acute care aging brain attentional control brain based cost dementia care depressive symptoms effectiveness research evidence base experience feasibility trial follow-up health application implementation research informal caregiver informal support innovation mobile application mobile computing neuropsychiatry pilot trial primary endpoint primary outcome programs psychological symptom randomized, clinical trials remote health care remote intervention sex systematic review telehealth therapy development user centered design

项目摘要

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/摘要在患有阿尔茨海默氏病和相关痴呆症（ADRD）及其非正式护理人员的患者中痴呆（BPSD）的行为和心理症状是至关重要的需求，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，但它们是管理不善，仍然是看护人伯恩的主要来源。技术可能是解决方案；确实，国家老龄化和其他研究所要求基于移动技术的行为干预措施以支持 ADRD患者的非正式护理人员。现有手机的系统评价和市场分析技术或“应用程序”表现出了前景，但关键局限性：缺乏科学基础和证据效率;缺少功能和功能；和低至中等的质量。我们的跨学科团队遵循NIH阶段的行为干预开发模型： 1）建立基于证据的干预模型（NIH模型阶段0）； 2）应用用户 - 将这种基于证据的模型嵌入大脑货物的中心设计，这是一种移动远程医疗应用（NIH）模型阶段IA）； 3）进行I-Care，这是一项设置试点研究，建立了可行性和潜力脑载体的功效（NIH模型IB-II）。试点研究表明，在6个月中终点，大脑菜鸟减少了非正式护理人员伯恩，而BPSD减少了。在这里，我们提出了I-Care 2，III期随机临床试验（RCT），作为NIH阶段的下一步模型。 I-Care 2将评估大脑菜单在非正式的主要结果上的现实效率照顾者伯恩（Burnen）和BPSD 12个月。我们计划注册n = 160个社区居住，说英语印第安纳州的ADRD患者的非正式护理人员。非正式护理人员将被随机分配（通过性别和种族分层）为12个月的脑脑（n = 80）或注意力控制教育应用程序（痴呆指南专家）（n = 80）。随访将在12个月进行，并在6个月时进行额外评估测试早期效果。我们将检验主要假设，相对于注意力控制，非正式护理人员随机分配到大脑菜谱将具有：（H1）通过护理人员遇险测量的较低的照顾者燃烧神经精神库存（NPI）的子评分；（H2）较低的BPSD，如NPI总分所测量。将测试次级假设，以比较（H3）抑郁症状的组患者健康问卷（PHQ）-9和（H4）急性护理利用率由医院数量确定以及在全州范围内卫生信息交换中捕获的急诊室就诊。如果成功的话，这项NIH III期RCT研究将产生高度可扩展性非 - 的效率的证据 BPSD的药理干预措施，这是ADRD护理中最繁重的方面之一。如果我们的照顾者 - 面对移动远程医疗应用程序在现实环境中有效，随后的阶段IV-V有效性和实施研究工作可以帮助缓解ADRD的严重公共卫生烧伤。