Web-enabled social interaction to delay cognitive decline among seniors with MCI: Phase I

基于网络的社交互动可延缓 MCI 老年人认知能力下降：第一阶段

• 批准号: 9898209
• 负责人: HIROKO Hayama DODGE
• 金额: $ 72.2万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898209
• 关键词: Adherence; Advanced Development; Age; Aged, 80 and over; Aging; Algorithms; Alzheimer' s Disease; Amygdaloid structure; Area; Atrophic; Attention; Brain; Brain imaging; Characteristics; Cognition; Cognitive; Communication; Communities; Control Groups; Cross-Sectional Studies; Dementia; Developed Countries; Diffusion Magnetic Resonance Imaging; Elderly; Face; Feasibility Studies; Filler; Functional Magnetic Resonance Imaging; Funding; Future; Health; Hippocampus (Brain); Home environment; Impaired cognition; Incidence; Internet; Intervention; Interviewer; Language; Lead; Location; Low income; Magnetic Resonance Imaging; Meals on Wheels; Memory; Michigan; Monitor; Moods; Oregon; Outcome; Outcome Measure; Participant; Personal Computers; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Prefrontal Cortex; Prevalence; Prevention; Prevention approach; Protocols documentation; Public Health; Randomized; Research Project Grants; Rest; Risk Factors; Sample Size; Sampling; Social Interaction; Social Network; Social isolation; Speech; Speed; Structure; Technology; Temporal Sulcus; Time; Training; Treatment Efficacy; United States National Institutes of Health; Well in self; aged; aging population; base; behavioral clinical trial; cognitive function; cost effective; efficacy study; efficacy trial; epidemiology study; ethnic minority population; executive function; group intervention; high risk; imaging study; improved; inclusion criteria; instrumental activity of daily living; intervention cost; intervention effect; mild cognitive impairment; morphometry; phase 1 study; phase I trial; primary outcome; recruit; secondary outcome; social; therapy development; touchscreen; user-friendly; web-enabled; week trial

Larger social networks and/or more frequent social interactions are associated with lower incidence of AD, at the population level; increasing social interaction may be a promising intervention for improving the cognitive well-being of older adults. In our previous randomized controlled behavioral clinical trial, we developed a conversation-based social interaction cognitive stimulation protocol delivered by trained interviewers through personal computers, webcams, and a user-friendly interactive Internet interface with a touch screen (ClinicalTrials.gov:NCT01571427). Daily 30-minute face-to-face communications were conducted over a 6- week trial period in the intervention group. Despite a small sample size, this pilot study (completed 6/30/2014) demonstrated feasibility, high adherence in an elderly population (mean age 80 years) and efficacy in language-based executive functions among the intervention group in comparison to the control group. Based upon these positive results, we propose a Phase I trial to advance development of this intervention. Primary aim (Aim 1) is to examine the efficacy of our intervention on cognitive functions among the target group - those aged 80 and older with MCI and limited opportunities of social interactions. Our primary outcomes are cognitive functions in the domains of language, attention, executive and memory functions, and secondary outcomes are a targeted IADL function (medication use and adherence) and overall emotional well-being (mood, self-rated health). Person-specific levels of social interactions (i.e., average conversation outside of the trial) will be monitored and controlled in the analyses. Exploratory Aim 2 is to examine whether the intervention could lead to changes in speech and language characteristics over time by analyzing recorded daily conversational sessions, based on our promising cross-sectional findings in this area. Exploratory Aim 3 is to examine underlying mechanisms of efficacy by assessing pre- and post- trial changes inhippocampal, dorsolateral prefrontal cortex, amygdala and other ROIsusing MRI and unbiased whole brain assessment (voxel-based morphometry), and structural and functional connectivity using diffusion tensor imaging (DTI) and resting state functional MRI (R-fMRI). A total of 144 MCI subjects will be recruited and randomized at Portland, Oregon, and Detroit, Michigan, collaborating with Meals on Wheels and Area Agency on Aging (AAA) at both locations, creating a large sampling frame of those with low income and from ethnic minorities. Half of the participants will be randomly selected and invited to participate in the brain imaging study. Increasing daily social contact through communication technologies could offer a cost-effective home- based prevention that could slow cognitive decline, delay the onset of AD, and thereby reduce the overall societal burden of dementia. The oldest old is the fastest growing segment of the population in most developed countries, and face the highest risk of developing dementia and social isolation (risk factors of adverse health outcomes). User-friendly sustainable prevention approaches are urgently needed in this population.

较大的社交网络和/或更频繁的社交互动与较低的 AD 发病率相关， 人口水平；增加社交互动可能是改善认知能力的一种有希望的干预措施 老年人的福祉。在我们之前的随机对照行为临床试验中，我们开发了一种 由训练有素的访谈员通过以下方式提供基于对话的社交互动认知刺激协议 个人电脑、网络摄像头以及带有触摸屏的用户友好型交互式互联网界面 （ClinicalTrials.gov：NCT01571427）。每天进行 30 分钟的面对面交流，为期 6 至 干预组的试验期为一周。尽管样本量很小，但这项试点研究（于 2014 年 6 月 30 日完成） 已证明可行性、老年人群（平均年龄 80 岁）的高依从性和有效性 与对照组相比，干预组基于语言的执行功能。 基于这些积极的结果，我们建议进行一期试验以推进该药物的开发 干涉。主要目的（目标 1）是检查我们的干预对认知功能的有效性 目标群体 - 80 岁及以上患有 MCI 且社交机会有限的人。我们的 主要结果是语言、注意力、执行和记忆领域的认知功能 功能，次要结果是目标 IADL 功能（药物使用和依从性）和总体 情绪健康（情绪、自评健康）。特定于个人的社交互动水平（即平均 试验之外的谈话）将在分析中受到监测和控制。探索性目标 2 是 检查干预是否会导致言语和语言特征随时间的变化 根据我们在该领域有希望的横截面研究结果，分析记录的日常对话会话。 探索性目标 3 是通过评估试验前和试验后的变化来检查潜在的功效机制 使用 MRI 和无偏全脑在海马、背外侧前额皮质、杏仁核和其他 ROI 中进行观察 评估（基于体素的形态测量）以及使用扩散张量的结构和功能连接 成像（DTI）和静息态功能磁共振成像（R-fMRI）。总共将招募144名MCI受试者 与 Meals on Wheels 和 Area Agency 合作，随机在俄勒冈州波特兰和密歇根州底特律进行 两个地点的老龄化（AAA），创建了一个低收入和少数民族人口的大型抽样框架 少数民族。一半的参与者将被随机选择并邀请参加脑成像研究。 通过通信技术增加日常社交接触可以提供具有成本效益的家庭 基于预防的方法可以减缓认知能力下降，延缓 AD 的发作，从而减少总体认知能力下降 痴呆症的社会负担。在大多数发达国家，最年长的老年人是人口中增长最快的部分 国家，并面临着患痴呆症和社会孤立的最高风险（不良健康的风险因素） 结果）。该人群迫切需要用户友好的可持续预防方法。