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

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.PROJECT NARRATIVE OnTRACK is a mobile health system that will help children who sustain a concussion with symptom management during their recovery. Recovery time typically takes up to a month while some children remain unable to return to their normal activities for a prolonged period of time. The app will help patients, their families, doctors, and schools track symptoms and identify problems early during the recovery, offering evidence-based intervention guidance to reduce and eventually eliminate persistent symptoms.