The Clinical Core will support in-person and virtual research visits for three of the four Research Projects at the University of Rochester Udall Center

临床核心将为罗切斯特大学尤德尔中心四个研究项目中的三个提供现场和虚拟研究访问

• 批准号: 10459489
• 负责人: GIOVANNI SCHIFITTO
• 金额: $ 12.03万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10459489
• 关键词: Cellular Phone; Clinical; Clinical Investigator; Clinical Research; Clinical assessments; Communities; Computer software; Country; Data; Disease model; Enrollment; Evaluation Research; Fostering; Foundations; Foxes; Funding; Geography; Health Technology; Individual; Informed Consent; Infrastructure; International; Internet; LRRK2 gene; Lead; Leadership; Longitudinal Studies; Longitudinal cohort study; Measures; Modeling; Nerve Degeneration; Neurologist; Outcome Measure; Participant; Persons; Pharmacologic Substance; Phenotype; Privacy; Research; Research Personnel; Research Project Grants; Research Support; Resources; Secure; Services; Site; Standardization; United States National Institutes of Health; Universities; Videoconferencing; Vision; Visit; advanced analytics; clinical center; community based participatory research; data management; data sharing; experience; models and simulation; new technology; novel; recruit; remote assessment; remote consent; research study; sensor; validation studies; video visit; virtual; virtual assessment; wearable sensor technology

SUMMARY The UR-Udall Center's Clinical Core has the capability to conduct remote assessments nationally and in- person assessments locally. For a decade, the Core's investigators have pioneered the use of video visits to conduct phenotypic assessments of individuals with PD and other neurodegenerative conditions. These efforts have involved novel partners, including 23andMe, pharmaceutical companies, and the Michael J. Fox Foundation. The largest effort connected 166 participants with PD in 39 states all to a single research “site.” The Core will use simple, secure video conference software and inexpensive web cameras to support Project 2 and enable the first virtual, national longitudinal study of LRRK2 carriers with and without PD. The Clinical Core also has extensive experience conducting in-person assessments to evaluate the relationship between traditional measures and those conducted with novel sensors, including smartphones and wearable sensors that are part of Projects 3 and 4. In addition, the Clinical Core and its outstanding partners can recruit research participants nationally and internationally. In one smartphone study, over 15,000 individuals nationally enrolled in seven months, and in another, we recruited 1600 participants from ~13 countries. The Clinical Core will be led by Dr. Giovanni Schifitto, a NIH-funded investigator who has helped lead multiple large scale clinical research efforts, and will be supported by a cadre of junior and senior clinical investigators with extensive experience conducting remote and in-person research evaluations. The Core will also include John Wilbanks, the Chief Commons Officer at Sage Bionetworks and one of the country's leading thinkers and practitioners of informed consent, to help guide the Center's multiple remote studies. Supported by experts in project and data management, the Clinical Core is poised to be an outstanding resource for the UR-Udall Center, the network of Udall Centers, and the broader PD community.

总结 UR-Udall中心的临床核心有能力在全国范围内进行远程评估， 当地人评价。十年来，核心的调查人员率先使用视频访问， 对患有PD和其他神经退行性疾病的个体进行表型评估。这些努力 有新的合作伙伴，包括23andMe，制药公司和迈克尔·J·福克斯 基金会最大的努力连接166名参与者与PD在39个州都到一个单一的研究“网站”。 核心将使用简单、安全的视频会议软件和廉价的网络摄像头来支持项目2 并使第一个虚拟的，全国性的纵向研究LRRK 2载波与无PD。 临床核心也有丰富的经验进行面对面评估，以评估 传统措施与使用新型传感器（包括智能手机）进行的措施之间的关系， 可穿戴传感器是项目3和4的一部分。此外，Clinical Core及其优秀的合作伙伴 可以在国内和国际上招募研究参与者。在一项智能手机研究中， 在另一项研究中，我们招募了1600名来自13个国家的参与者， 国家 临床核心将由NIH资助的研究人员Giovanni Schifitto博士领导，他曾帮助领导 多个大规模的临床研究工作，并将由初级和高级临床干部的支持， 具有丰富经验的研究人员进行远程和面对面的研究评价。芯会 还包括Sage Bionetworks的首席下议院官员John Wilbanks， 知情同意的思想家和实践者，以帮助指导该中心的多个远程研究。 在项目和数据管理专家的支持下，临床核心有望成为一个杰出的 UR-Udall中心，Udall中心网络和更广泛的PD社区的资源。