PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Gra

PHS 2018-02 NIH、CDC 和 FDA 小型企业创新研究综合征集

• 批准号: 10158773
• 负责人: ODILE H CLAVIER
• 金额: $ 52.49万
• 依托单位: CREARE, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2021-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158773
• 关键词: PHS; 2018; 02; Omnibus; Solicitation

PROJECT SUMMARY/ABSTRACT Creare and its clinical and research partners propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI). The platform includes a mobile application (app) for the patients and their care team (parents, teachers, coaches, etc.), a database server, and a decision support dashboard for healthcare providers. The OnTRACK app prompts the patient to report post-concussion symptoms across recovery in two distinct but equally important ways: cross-recovery graded symptom ratings to track overall recovery progress, and short-term daily dynamic exertional symptom responses to guide activity. Teachers, parents, coaches, and other authorized members of the patient care team also report patient progress when prompted. Beyond symptom reporting, the app provides education in the form of short multimedia clips that cover various topics related to concussion recovery based on the PACE (Progressive Activities of Controlled Exertion) model. Using a large existing dataset on typical recovery trajectories, if the serial symptom reports indicate an atypical pattern, the healthcare provider receives an alert to assess further and consider referral for additional treatment. To guide daily recovery, OnTRACK uses empirically-derived algorithms to determine when the level of symptom exacerbation reaches a certain threshold, delivering specific directive feedback (after approval by healthcare provider) to the child to manage daily activities and reduce disruptive symptoms. The goal of the OnTRACK system is to afford the healthcare provider, patient, and family with data-driven decision upon which to follow evidence-based treatment guidelines.

项目概要/摘要 Creare 及其临床和研究合作伙伴提议开发一个软件平台 OnTRACK（Online 儿童脑震荡治疗康复援助），针对从脑震荡中恢复的儿童和青少年 脑震荡或轻度创伤性脑损伤 (mTBI)。该平台包括一个移动应用程序（app） 患者及其护理团队（家长、老师、教练等）、数据库服务器和决策支持 医疗保健提供者的仪表板。 OnTRACK 应用程序提示患者报告脑震荡后情况 以两种不同但同样重要的方式评估康复过程中的症状： 交叉康复分级症状评级 跟踪总体恢复进度以及短期每日动态运动症状反应以指导 活动。教师、家长、教练和患者护理团队的其他授权成员也报告 出现提示时患者的进展。除了症状报告之外，该应用程序还以简短的形式提供教育 多媒体剪辑，涵盖与基于 PACE（渐进式）脑震荡恢复相关的各种主题 受控用力活动）模型。在典型的恢复轨迹上使用大型现有数据集，如果 连续症状报告表明存在非典型模式，医疗保健提供者会收到警报以进一步评估 并考虑转诊接受额外治疗。为了指导日常恢复，OnTRACK 使用经验得出的数据 确定症状恶化程度何时达到某个阈值的算法，从而提供 向孩子提供具体的指令反馈（经医疗保健提供者批准后）以管理日常活动和 减少破坏性症状。 OnTRACK 系统的目标是为医疗保健提供者、患者、 和家庭做出数据驱动的决定，并遵循循证治疗指南。