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Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK) for Concussion (OnTRACK Trial)

N/A
Waitlist Available
Led By Gerard Gioia
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. the questionnaire will take five minutes to complete.
Awards & highlights

OnTRACK Trial Summary

This trial is testing a software platform, OnTRACK, to help children and adolescents recovering from concussion or mild brain injury. The platform includes a mobile app, a database server, and a decision support dashboard for healthcare providers.

Eligible Conditions
  • Concussion

OnTRACK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. questionnaires will take five minutes to complete.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. questionnaires will take five minutes to complete. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Communication with Patients, Parents, HCPs and School Staff
The OnTRACK symptom monitoring system's effect on the HCP confidence in clinical decision-making, patient/ parent/ school confidence in carrying out management guidance
The usability of the OnTRACK symptom monitoring system
Secondary outcome measures
Change in knowledge associated with the educational videos
Examine patient symptom recovery outcomes (parent reported)
Examine patient symptom recovery outcomes (self-reported)
+2 more

OnTRACK Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OnTRACK InterventionExperimental Treatment1 Intervention
In the intervention condition, HCPs will be trained in the usage of the OnTRACK system. They will be oriented to the educational videos, the symptom tracking, and the interpretation of the data that is provided by the patients and families, and the associated management strategies based on that data. Additionally, patients and parents will be trained to use the OnTRACK smartphone app on their phone from diagnosis to recovery (or 12 weeks if not recovered), including daily exertional monitoring symptom ratings and use of the educational videos. School personnel will be introduced to the OnTRACK app and the data summary features in the school dashboard and the associated supports that can be provided to the student based on that data.
Group II: Treatment as UsualActive Control1 Intervention
In the control condition, the HCP provides "usual/standard care" to the patients and parents as is the practice within the specific clinic. The OnTRACK app and the educational modules are not provided.

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Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
214 Previous Clinical Trials
208,879 Total Patients Enrolled
Creare, Inc.Industry Sponsor
3 Previous Clinical Trials
42 Total Patients Enrolled
Gerard GioiaPrincipal InvestigatorChildren's National Research Institute
~122 spots leftby Jun 2025
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