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

新型研究基础设施可实现健康老龄化的生命历程研究

• 批准号: 10475012
• 负责人: Lydia Bazzano
• 金额: $ 76.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10475012
• 关键词: Adult; Aging; Blood; Cellular Phone; Childhood; Clinic; Complement; Consent; Data; Data Collection; Databases; Devices; Dietary intake; Electrocardiogram; Electronic Mail; Enrollment; Epidemiology; Evaluation; Feasibility Studies; Feces; Gold; Health Insurance Portability and Accountability Act; Heart Rate; Home; Interview; Investments; Life; Life Cycle Stages; Longitudinal Studies; Measurement; Measures; Methods; Online Systems; Outcome; Outcome Study; Paper; Participant; Persons; Phase; Physical Performance; Physical activity; Physiologic pulse; Physiological; Procedures; Quality of life; Questionnaires; Race; Research; Research Infrastructure; Resources; Risk Factors; Saliva; Sampling; Schedule; Science; Site; Sleep; Social isolation; Telephone; Telephone Interviews; Time; Training; United States National Institutes of Health; Validation; Visit; base; cognitive function; cohort; data quality; feasibility testing; functional independence; healthy aging; home test; lifestyle factors; male; middle age; mobile computing; multiple chronic conditions; novel; recruit; remote assessment; response; sample collection; sex; smartphone based assessment; tool; validation studies; virtual; wearable device

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.

过渡到 R33 阶段的摘要 该提案将增强独特的科学资源，促进有效的生命历程方法来定义 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。该资源将补充来自早期生活报道较少的纵向研究的数据，从而 推进成功老龄化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）的目的是论证可行性并定义远程评估与衰老相关的最佳方法 通过以下方式影响分散的流行病学队列： 目标 1：进行访谈和管理问卷 评估中年认知功能、社会孤立、多种慢性病、生活质量、功能 使用经过验证的问卷和工具（包括 NIH Toolbox 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 家庭环境中的技术。我们将评估是否远程样本采集（例如唾液、粪便）、 生理评估（例如心率、血液实验室、心电图、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 与亲自访问的黄金标准相比，高质量的研究数据。为了实现目标#1，我们将确定 从已经参加 i3C 结果研究的每个队列中随机抽取 150 名参与者 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接受培训 管理评估。回答将被输入研究特定的 REDCap 数据库，即 HIPAA- 杜兰大学和 CCHMC 均提供基于网络的合规数据库。我们的目标是招募具有多种能力的受试者 数据点涵盖了童年和成年期，他们将有数十年的参与时间。为了实现目标#2，每个 队列将在电话采访（R33 目标 1）时招募 50 名参与者（总共 150 名）参加 可穿戴技术的额外可行性研究以及现场验证访问。科目将由以下人员选择 距离诊所地点的远近、智能手机的使用情况、性别（50% 为男性）和种族（基于每个人的比例） 队列）。在此电话通话期间，将解释额外的同意程序，以及亲自验证 研究访问将安排在家庭数据收集后的一周。虚拟诊所研究套件将是 邮寄，并附有纸质同意书。所有收到邮寄的家用设备的参与者都将被安排 在家测试后的接下来 1-2​​ 周内前往杜兰大学或 CCHMC 亲自进行诊所就诊。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 目标 1 中的家用设备或电话/问卷评估。R33 的里程碑和时间表 阶段如下表所示。 R33阶段的可交付成果包括：（1）招募450名受试者 （每组 150 名）进行电话采访； (2) 完成对移动设备的家庭和现场评估 150 个科目的技术（50 个/队列）； (3) 可行性、可接受性、有效性和数据质量评价。