Online Treatment Recovery Assistance for Concussion in Kids

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.

Conditions

• Concussion
• MTBI - Mild Traumatic Brain Injury

Interventions

DEVICE

Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)

Patients and families will be provided the smartphone app on their personal mobile phone (Android, iPhone) or provided with a phone if they do not own one. The patients will view educational videos on concussion management, input their daily exertional status and weekly symptom status upon receiving pre-programmed notification prompts on their phone. Healthcare Providers will monitor symptom recovery via an HCP dashboard and make management recommendations using evidence-based algorithms regarding symptom recovery status. School personnel will monitor progress via a dashboard and provide targeted supports, they may also view educational videos on concussion management. Opportunities for communication between the HCP, parent/patient and school will be provided by the app.

Sponsors & Collaborators

• Creare, Inc.

  collaborator INDUSTRY

• Children's National Research Institute

  lead OTHER

Principal Investigators

• Gerard Gioia, PhD · Children's National Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-28

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• United States

Study Locations