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

项目摘要/摘要 Creare及其临床和研究合作伙伴建议开发一个软件平台OnTrack(在线 儿童震荡治疗恢复援助)，为儿童和青少年康复 脑震荡或轻度创伤性脑损伤(MTBI)。该平台包括移动应用程序(App)，用于 患者及其护理团队(父母、教师、教练等)、数据库服务器和决策支持 医疗保健提供者的仪表盘。OnTrack应用程序提示患者报告脑震荡后 以两种不同但同样重要的方式跨越康复的症状：交叉恢复分级症状评级 跟踪整体康复进度，并对短期每日动态劳累症状反应进行指导 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说 出现提示时，患者会有进展。除了症状报告之外，这款应用程序还以简短的形式提供教育 涵盖与脑震荡恢复相关的各种主题的多媒体剪辑(基于速度(渐进式 受控运动)模型。在典型的恢复轨迹上使用大型现有数据集，如果 一系列症状报告显示非典型模式，医疗保健提供者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使用经验派生的 确定症状恶化程度何时达到特定阈值的算法，提供 向儿童提供特定的指令反馈(在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、 和家人有数据驱动的决定，在此基础上遵循循证治疗指南。

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.