A novel research infrastructure enabling life-course studies of healthy aging

向R33相过渡的摘要 这项提议将加强一个独特的科学资源，促进有效的生命过程方法来定义 成功老龄化的理想途径，利用NIH数十年的投资并允许探索新的 假设。这一资源将补充来自纵向研究的数据，而对早期生活的报道较少，因此 推进成功老龄化的科学，并提供证据以实现与老龄化相关的远程评估 结果，然后可以应用于其他队列。加强和扩大活动的具体目标 阶段(R33)旨在演示可行性并定义远程评估与老龄化相关的最佳方法 分散的流行病学队列中的因素：目标1：进行访谈和发放问卷 评估中年认知功能、社会隔离、多种慢性病、生活质量、功能 独立性和身体表现，使用经过验证的问卷和工具，包括NIH工具箱和 PROMIS评估；目标2：测试使用移动设备评估风险因素数据的可行性和有效性 居家环境中的技术。我们将评估远程样本采集(如唾液、粪便)， 生理评估(例如，心率、血液实验室、心电、脉搏波速度)、客观测量的生活方式 通过家庭移动技术评估的因素(例如，体力活动、睡眠)和饮食摄入量会产生高 与面对面访问的黄金标准相比，高质量的研究数据。为了实现第一个目标，我们将确定 从已经参与i3C结果研究的每个队列中随机抽取150名参与者为 通过电话、邮件和/或电子邮件联系。研究协调员将获得同意，并将接受培训 管理评估。这些答复将被输入一个专门针对研究的红帽数据库，HIPAA- 杜兰大学和CCHMC均提供合规的基于网络的数据库。我们的目标是用多个主题来重复使用它 从童年到成年的数据点，他们将有几十年的参与。为了实现目标2，每个人 队列将在电话面试时招募50名参与者(总计150人)(R33目标1)以参与 可穿戴技术的其他可行性研究，以及面对面的验证访问。主题将由以下人员选择 距离诊所地点近，使用智能手机，性别(50%男性)和种族(基于每个人的比例 队列)。在这次电话通话中，将解释额外的同意程序，并亲自进行验证 研究访问将安排在家庭数据收集后的一周进行。一个虚拟诊所学习工具包将是 邮寄，并附上书面同意书。所有收到邮寄的家庭设备的参与者将被安排在 在家庭测试后的1-2周内在杜兰或CCHMC进行面对面的临床访问。在此期间 访问期间，参与者将接受以下评估，这些评估将用于验证来自 家庭设备或电话/问卷评估目标1.R33的里程碑和时间 各阶段如下表所示。R33阶段的交付成果包括：(1)招募450名受试者 (每组150人)进行电话采访；(2)完成对移动电话的上门和面对面评估 (3)可行性、可接受性、有效性和数据质量的评估。

ABSTRACT for transition to R33 Phase This proposal will enhance a unique scientific resource that will facilitate valid life-course approaches to define the ideal path to successful aging, leveraging decades of NIH investment and allowing exploration of new hypotheses. This resource will complement data from longitudinal studies with less coverage of early life, thereby advancing the science of successful aging and providing evidence to enable remote assessment of aging-related outcomes, which can then be applied to other cohorts. Specific aims for the enhanced and expanded activities phase (R33) are to demonstrate feasibility and define the best methods for remotely assessing aging-related factors in dispersed epidemiologic cohorts by: Aim #1: Conducting interviews and administering questionnaires to assess mid-life cognitive function, social isolation, multiple chronic conditions, quality of life, functional independence, and physical performance using validated questionnaires and tools, including NIH Toolbox and PROMIS assessments; and Aim #2: Testing the feasibility and validity of assessing risk factor data using mobile technology in an in-home setting. We will evaluate whether remote sample collection (e.g., saliva, stool), physiologic assessments (e.g., heart rate, blood labs, ECG, pulse-wave velocity), objectively-measured lifestyle factors (e.g., physical activity, sleep) and dietary intake assessed by in-home mobile technology produce high- quality research data, compared with the gold standard of in-person visits. To achieve Aim #1, we will identify a random sample of 150 participants from each cohort already participating in the i3C Outcomes study wi ll be contacted by phone, mail and/or email. The research coordinator will obtain consent and will be trained to administer the assessments. The responses will be entered into a study-specific REDCap database, a HIPAA- compliant web-based database available at both Tulane and CCHMC. We aim to recru it subjects with multiple data points across childhood and adulthood, who will have decades of participation. To achieve Aim #2, each cohort will enroll 50 participants (150 total) at the time of phone interview (R33 Aim 1) to participate in an additional feasibility study of wearable technology, and an in-person validation visit. Subjects will be selected by proximity to the clinic site, access to a smartphone, sex (50% male), and race (based on proportion in each cohort). During this phone call, additional consent procedures will be explained, and the in-person validation study visit will be scheduled for the week following the home data collection. A Virtual Clinic study kit will be mailed, along with a paper consent. All participants receiving the mailed in-home devices wil l be scheduled for an in-person clin ic visit at Tulane or CCHMC during the next 1-2 weeks after the in-home testing. During this visit, participants will undergo the following assessments, which will be used to validate the measurements from the in-home devices or the telephone/questionnaire assessments from Aim 1. Milestones and ti meline for R33 phase are presented in the Table below. Deliverables from the R33 phase include: (1) Recruit 450 subjects (150 per cohort) for telephone interviews; (2) Complete in-home and in-person assessments of mobile technology on 150 subjects (50/cohort); and (3) Evaluation of feasibility, acceptabi lity, validity and data quality.