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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
Children aged 8-17 years old
Primary care practitioners and their clinical assistants (e.g., nurse, PA) (n = 22)
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

OnTRACK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will complete the survey when they are no longer symptomatic and are deemed recovered, or at 12 weeks after enrollment if they are not recovered. the questionnaire 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 recovered, or at 12 weeks after enrollment if they are not recovered. the questionnaire 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
209 Previous Clinical Trials
207,337 Total Patients Enrolled
Creare, Inc.Industry Sponsor
3 Previous Clinical Trials
42 Total Patients Enrolled
Gerard GioiaPrincipal InvestigatorChildren's National Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently accept new participants?

"Yes, clinicaltrials.gov confirms that this medical experiment is still seeking volunteers. It was first posted on February 1st 2022 and the latest update took place October 10th of the same year. They are looking to recruit 408 participants at one site."

Answered by AI

How many individuals are taking part in this exploration?

"Affirmative. According to information available on clinicaltrials.gov, this examination is currently recruiting patients with the posting date of February 1st 2022 and a recent edit made on January 10th 2022. A total of 408 individuals need to be enrolled from one site for participation in this research project."

Answered by AI

Does this research endeavor accept participants who are over 25?

"This clinical trial seeks out participants that are between 8 and 17 years old."

Answered by AI

What type of person would best benefit from participating in this research?

"This research is seeking 408 minors between the ages of 8 and 17 who have recently sustained a concussion. To qualify for this study, children must meet certain criteria: they must be accompanied by their primary care physician or an assigned clinical assistant; those visiting Children's National SCORE Concussion/Neurology clinics need to arrive within 30 days of injury; participants and caregivers should both speak English fluently; consent to the trial conditions, as well as provide informed assent/parental permission. Furthermore, faculty members from the patient's school can also participate in this experiment if pre-selected by child/guardian."

Answered by AI

What objectives has this trial set out to accomplish?

"The primary outcome of this trial will be determined over a period of time by evaluating patient communication with healthcare professionals, parents, school staff and patients themselves. As part of the process, participants must complete a five-minute questionnaire indicating their symptom recovery status when they are no longer symptomatic or after 12 weeks have elapsed since enrolment. Secondary outcomes consist of examining self-reported and school-reported symptom recovery via post-concussion symptom inventory (PCSI) scores and concussion learning assessment & school survey (CLASS-3). The CLASS 3 score range varies from 0 to 126 for adolescents, 0 to 34 for children while higher scores indicate greater academic"

Answered by AI
~132 spots leftby Mar 2025