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Clinical Trial Summary

The investigators 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: a weekly cross-recovery graded symptom ratings to track overall recovery progress, and short-term daily dynamic exertional symptom responses to guide tolerable daily activity. Teachers and parents and other authorized members of the patient care team also report patient progress when prompted. Beyond symptom reporting, the app provides access to 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 several large existing datasets on recovery trajectories, the serial symptom reports indicate (a) level of symptom severity, change over time, and whether recovery is following a typical or atypical pattern. The healthcare provider is regularly updated regarding recovery progress and, if an atypical pattern is reported, he/she 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 an alert to the healthcare provider who can give feedback to the child to manage daily activities and reduce disruptive symptoms. The primary goal of the OnTRACK system is to afford the healthcare provider, patient, and family greater confidence with data-driven decisions upon which to follow evidence-based treatment guidelines and to improve communication between family and provider.

Clinical Trial Description

The investigators will study the usability of a smartphone app (Online Treatment Recovery Assistant for Concussion in Kids, OnTRACK), its effect on provider management confidence, and communication plus a preliminary analysis of the benefits on patient recovery outcomes. The study will recruit 126 children, parent, school staff triads (n=378) along with their healthcare provider (HCP) including 22 primary care from the CN Pediatric Health Network and 8 specialists from the CN Safe Concussion Outcome, Recovery & Education (SCORE) clinics and Neurology clinics. The participants will track and monitor the child's symptoms and respond to HCP guidance over the course of recovery (up to 12 weeks), employing evidence-based algorithms related to recovery progress. The investigators hypothesize that the HCP will experience: (1) positive satisfaction in using the app, (2) increased confidence in their management guidance, and (3) increased communication with patients, families and school staff when using the OnTRACK app as compared to a control group who receives standard treatment without the OnTRACK app. The investigators further hypothesize that in using the OnTRACK app as compared with control group, patients, parents and school personnel will report: (1) positive satisfaction in using the app, (2) increased confidence in their symptom management, and (3) increased communication with the HCP. Additionally, the investigators hypothesize that the OnTRACK educational videos will be rated as useful and improve the understanding of the patient, parent and school regarding concussion and its management. Finally, the investigators hypothesize that patients will develop a better understanding of the dynamics of their exertional symptoms as related to school and home activities by tracking their occurrence and learning productive strategies to manage them. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05065099
Study type Interventional
Source Children's National Research Institute
Contact Dean R Allen
Phone 202-476-5000
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date December 31, 2022

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