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

项目摘要 研究发现，更大的社交网络和更频繁的社交互动与更低的发病率有关 观察性研究中的痴呆症。增加社交互动可能是一种很有前途的干预措施 认知储备和维持老年人的认知福祉。在我们之前的随机对照研究中 行为临床试验，我们开发了一种基于对话的社交认知刺激方案 由训练有素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：NCT01571427)。每天30分钟的面对面交流 干预组在为期6周的试验期内进行交流。尽管样本很少 规模，这项初步研究(2014年6月30日完成)证明了在老年人口中的可行性和高依从性 (平均年龄80岁)和#年干预组基于语言的执行功能的有效性 与对照组比较。 基于这些积极的结果，我们建议进行第一阶段的试验，以促进这方面的发展 干预。主要目标(目标1)是检查我们对以下人群认知功能的干预效果 目标群体是那些75岁及以上患有MCI且社交机会有限的人。我们的 主要结果是通过蒙特利尔认知评估测试(MoCA)和 次要结果是基于语言的执行和记忆功能的认知领域。这些 认知结果用NIH工具箱认知电池组进行交叉验证。探索性成果包括： 有针对性的IADL功能(药物使用和依从性)和情绪健康。特定于个人的级别 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语言和语言的改变 通过分析记录的日常会话，随着时间的推移，基于我们的 在这一领域有很有希望的横断面发现。探索性目标3是检查潜在的机制 通过评估通过目标网络的功能磁共振连接性测量的试验前和试验后的变化来实现疗效 包括默认模式网络(DMN)、背部注意网络(DAN)和显著网络(SN)。 共有144名MCI受试者将在俄勒冈州波特兰和密歇根州底特律被招募和随机分配。一半的人 符合条件的参与者将被随机挑选并邀请参加脑成像研究。 通过通信技术增加日常社交联系可以提供一个经济实惠的家- 以预防为基础，可以减缓认知衰退，推迟AD的发病，从而降低整体 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 国家，并面临患痴呆症和社会孤立的最高风险(不利健康的风险因素 结果)。在这一人群中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.