The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications.
The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications.
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DOI：
10.3389/fdgth.2021.714813
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发表时间：
2021
影响因子：
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通讯作者：
Dodge HH
中科院分区：
文献类型：
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作者：
Yu K;Wild K;Potempa K;Hampstead BM;Lichtenberg PA;Struble LM;Pruitt P;Alfaro EL;Lindsley J;MacDonald M;Kaye JA;Silbert LC;Dodge HH
背景资料：通过通信技术增加社会互动可以提供一种具有成本效益的预防方法，减缓认知能力下降并延迟阿尔茨海默病的发作。本文介绍了一个活跃的项目，名为“基于互联网的会话参与临床试验（I-CONECT）”（ClinicalTrials.gov：NCT 02871921）的协议。COVID-19疫情相关方案修订亦于本文件中讨论。方法：I-CONECT是一项多中心、评估者盲法、随机对照的行为干预试验（RCT）。我们的目标是随机选择320名75岁以上的社交孤立成年人[160名白人和160名非洲裔美国人参与者，50：50分为正常认知和轻度认知障碍（MCI）]，从社区招募到视频聊天干预组或对照组（1：1分配）。视频聊天组中的受试者在研究期间接受计算机和互联网服务，他们使用该服务与研究工作人员进行视频聊天，每天30分钟，每周4次，持续6个月（高剂量），然后每周2次，持续6个月（维持剂量）。视频聊天组和对照组每周与研究工作人员进行一次简短的（约10分钟）电话登记。主要结局是通过蒙特利尔认知评估（莫卡）测量的总体认知功能从基线到6个月的变化。次要结果包括记忆和执行功能领域的认知变化，通过NIH情绪测试测量的情绪健康，以及通过修订的日常生活观察任务（OTDL-R）评估的日常功能能力。合格的参与者在基线和6个月时进行MRI。参与者贡献唾液进行基因检测（可选同意），所有视频聊天，每周签到电话和神经心理评估会议都被记录下来用于语音和语言分析。大流行使研究活动暂停，并导致方案修改，包括以远程评估取代亲自评估，远程部署研究设备，以及修改目标样本量。讨论：本试验为基于对话的干预提供了用户友好的硬件，可以在参与者家中轻松提供。该试验旨在使用本试验中开发的特定年龄和文化的对话材料和相关平台，以增强认知储备和改善认知功能。
Background: Increasing social interactions through communication technologies could offer a cost-effective prevention approach that slows cognitive decline and delays the onset of Alzheimer's disease. This paper describes the protocol of an active project named “Internet-based conversational engagement clinical trial (I-CONECT)” (ClinicalTrials.gov: NCT02871921). The COVID-19 pandemic related protocol modifications are also addressed in the current paper. Methods: I-CONECT is a multi-site, assessor-blind, randomized controlled behavioral intervention trial (RCT). We aim to randomize 320 socially isolated adults 75+ years old [160 Caucasian and 160 African American participants, 50:50 split between those with normal cognition and mild cognitive impairment (MCI)] recruited from the community to either the video chat intervention group or the control group (1:1 allocation). Those in the video chat group receive a computer and Internet service for the duration of the study, which they use to video chat with study staff for 30 min/day 4×/week for 6 months (high dose), and then 2×/week for an additional 6 months (maintenance dose). Both video chat and control groups have a brief (about 10 min) telephone check-in with study staff once per week. The primary outcome is the change in global cognitive function measured by Montreal Cognitive Assessment (MoCA) from baseline to 6 months. Secondary outcomes include changes in cognition in memory and executive function domains, emotional well-being measured by NIH Toolbox emotional battery, and daily functional abilities assessed with the Revised Observed Tasks of Daily Living (OTDL-R). Eligible participants have MRIs at baseline and 6 months. Participants contribute saliva for genetic testing (optional consent), and all video chats, weekly check-in calls and neuropsychological assessment sessions are recorded for speech and language analysis. The pandemic halted research activities and resulted in protocol modifications, including replacing in-person assessment with remote assessment, remote deployment of study equipment, and revised targeted sample size. Discussion: This trial provides user-friendly hardware for the conversational-based intervention that can be easily provided at participants' homes. The trial aspires to use age and culture-specific conversational materials and a related platform developed in this trial for enhancing cognitive reserve and improving cognitive function.