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

项目摘要 更大的社交网络和更频繁的社会互动被发现与较低的发病率有关 痴呆症的观察性研究。增加社会互动可能是一种有希望的干预措施， 认知储备和维持老年人的认知健康。在我们之前的随机对照研究中， 行为临床试验，我们开发了一个基于会话的社会互动认知刺激协议 由受过训练的面试官通过个人电脑、网络摄像头和用户友好的交互式 带触摸屏的互联网界面（ClinicalTrials.gov：NCT 01571427）。每天30分钟面对面 在干预组中进行了为期6周的试验。尽管样本很小 规模，这项初步研究（完成日期：2014年6月30日）证明了在老年人群中的可行性和高依从性 (mean年龄80岁）和干预组中基于语言的执行功能的有效性， 与对照组相比。 基于这些积极的结果，我们提出了一个I期试验，以推进这一发展。 干预主要目的（目的1）是检查我们的干预对认知功能的有效性， 目标群体-75岁及以上MCI患者和社交机会有限的人。我们 主要结局是通过蒙特利尔认知评估测试（莫卡）测量的整体认知功能， 次要结果是基于语言的执行和记忆功能中的认知领域。这些 认知结果结果由NIH工具箱认知电池交叉验证。探索性结果包括： 有针对性的IADL功能（药物使用和依从性）和情绪健康。个人特定水平 社会互动（即，试验外的平均对话）将在 分析。探索性目标2是检查干预是否会导致言语和 语言特征随着时间的推移，通过分析记录的日常会话，根据我们的 在这一领域有希望的横截面发现。探索性目标3是研究 通过评估试验前和试验后的疗效，通过功能磁共振成像（fMRI）连接性测量目标网络的变化 包括默认模式网络（DMN）、背侧注意网络（DAN）和显著性网络（SN）。 将在俄勒冈州的波特兰和密歇根州的底特律招募并随机分配共144例MCI受试者。半年 合资格的参与者将被随机挑选并邀请参加大脑成像研究。 通过通信技术增加日常社会联系可以提供一个具有成本效益的家庭- 基于预防，可以减缓认知能力下降，延迟AD的发作，从而减少整体 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。 在这些国家中，老年痴呆症和社会隔离的风险最高（不利健康的风险因素 成果）。这一人群迫切需要方便用户的可持续预防方法。

Project Summary Larger social networks and more frequent social interactions are found to be associated with lower incidence of dementia in observational studies. Increasing social interaction may be a promising intervention for increasing cognitive reserve and sustaining 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 75 and older with MCI and limited opportunities of social interactions. Our primary outcome is a global cognitive function measured by Montreal Cognitive Assessment tests (MoCA) and secondary outcomes are cognitive domains in language-based executive and memory functions. These cognitive outcome results are cross-validated by NIH toolbox cognitive battery. Exploratory outcomes include: a targeted IADL function (medication use and adherence) and emotional well-being. 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 measured by fMRI connectivity for targeted networks including the default mode network (DMN), the dorsal attention network (DAN), and the salience network (SN). A total of 144 MCI subjects will be recruited and randomized at Portland, Oregon, and Detroit, Michigan. Half of the eligible 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.