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

过渡到R33阶段的摘要 这项建议将加强一种独特的科学资源，促进有效的生命过程方法， 成功老龄化的理想途径，利用数十年的NIH投资，并允许探索新的 假设这一资源将补充纵向研究的数据，其中对早期生活的覆盖较少， 推进成功衰老的科学，并提供证据，使远程评估与衰老有关的 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）的目的是证明可行性，并确定远程评估老龄化相关的最佳方法 分散的流行病学队列中的因素：目的#1：进行访谈和管理问卷 评估中年认知功能、社会隔离、多种慢性疾病、生活质量、功能性 独立性和身体表现，使用经过验证的问卷和工具，包括美国国立卫生研究院和 PROMIS评估;目标2：测试使用移动的评估风险因素数据的可行性和有效性 技术在家庭环境中。我们将评估远程样本采集（例如，唾液、粪便）， 生理评估（例如，心率、血液实验室、ECG、脉搏波速度）、客观测量的生活方式 因素（例如，身体活动，睡眠）和饮食摄入量评估的家庭移动的技术产生高- 高质量的研究数据，与亲自访问的黄金标准相比。为了实现目标1，我们将确定 将从每个队列中随机抽取150名已参与i3 C结局研究的参与者， 通过电话、邮件和/或电子邮件联系。研究协调员将获得知情同意，并接受培训， 管理评估。将回复输入研究特定的REDCap数据库（HIPAA- 合规的基于网络的数据库，可在杜兰大学和CCHMC。我们的目标是用多种方法来重建它 儿童和成年期的数据点，他们将有几十年的参与。为了实现目标#2，每个 在电话采访时（R33目标1），队列将招募50名参与者（共150名）， 可穿戴技术的额外可行性研究，以及亲自验证访问。受试者将由以下人员选择： 接近诊所地点，使用智能手机，性别（50%男性）和种族（基于每种比例） 群组）。在此次电话会议期间，将解释额外的同意程序，并亲自验证 研究访视将安排在家庭数据收集后的一周。虚拟诊所学习包将 沿着邮寄了一份书面同意书。所有收到邮寄的家用设备的参与者将被安排在 在家庭测试后的接下来的1-2周内，在杜兰或CCHMC进行现场临床访视。在此 访视时，参与者将接受以下评估，这些评估将用于验证 家庭设备或目标1中的电话/问卷评估。R33的Military和timeline 下表中列出了阶段。R33阶段的可接受条件包括：（1）招募450例受试者 (150（2）完成移动的的家庭和面对面评估 技术对150例受试者（50例/队列）的研究;（3）可行性、可接受性、有效性和数据质量评价。

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.