← Back to Search

Concussed youth at risk for prolonged symptoms for Traumatic Brain Injury

N/A

Recruiting

Led By Daniel J Corwin, MD, MSCE

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 year of completing study procedures

Awards & highlights

Study Summary

This trial aims to test if a mobile health tool can help teenagers with concussions get better care. Patients will use an app to report their symptoms and activity daily, and the app will connect them to

Who is the study for?

This trial is for 13-18 year olds who've had a concussion and are at moderate-to-high risk of long-term symptoms. They must have been to the Children's Hospital of Philadelphia within 72 hours of injury, own a smartphone, and meet specific medical criteria for concussion severity.Check my eligibility

What is being tested?

The study tests an mHealth tool that tracks patient symptoms daily via chat technology linked to their health records. It aims to improve specialist access and care coordination for young patients with traumatic brain injuries.See study design

What are the potential side effects?

Since this trial involves using a mobile health tool rather than medication, traditional side effects aren't expected. However, there may be privacy concerns or stress related to daily symptom reporting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year of completing study procedures

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 year of completing study procedures

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year of completing study procedures for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)

Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation)

Secondary outcome measures

Days until clearance (Secondary Effectiveness)

Days until return to school (Secondary Effectiveness)

Days until return to symptoms baseline (Secondary Effectiveness)

+5 more

Other outcome measures

Incidence of Persistent Post-Concussion Symptoms (PPCS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Concussed youth at risk for prolonged symptomsExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,860 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,429 Total Patients Enrolled

Daniel J Corwin, MD, MSCEPrincipal InvestigatorChildren's Hospital of Philadelphia

Frequently Asked Questions

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

How many individuals are currently enrolled as participants in this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this particular medical investigation is actively in search of suitable candidates. The trial was initially shared on March 18, 2024 and underwent its most recent revision on March 20, 2024. A total of 160 participants are sought from a single designated location."

Answered by AI

Does this medical study enroll individuals who are aged 55 years or older?

"Individuals aged between 13 and 18 are eligible to participate in this clinical investigation. Notably, there are a total of 76 studies focusing on adolescents under the age of majority, while 283 trials cater specifically to those over the age of retirement."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Affirmative. Information sourced from clinicaltrials.gov highlights the ongoing recruitment efforts for this investigation. The trial's inception was on March 18, 2024, with the most recent update noted on March 20, 2024. A total of 160 participants are sought at a single research site."

Answered by AI

Which individuals meet the criteria to be considered for inclusion in this research study?

"This clinical investigation is open to enrollment for 160 adolescents aged between 13 and 18 who have experienced traumatic brain injury. Essential requirements include owning a mobile device, seeking care at the Children's Hospital of Philadelphia (CHOP) Emergency Department within 72 hours of head trauma, meeting concussion criteria outlined in the latest International Consensus Statement on Concussion, and demonstrating a moderate-to-high risk for Persistent Post-Concussion Symptoms based on the 5P rule (score >3/12)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Facilitating Access to Specialty Treatment

2024. "Facilitating Access to Specialty Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741411.