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Mobile Health Tool for Concussions
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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Days until clearance (Secondary Effectiveness)
Days until return to school (Secondary Effectiveness)
Days until return to symptoms baseline (Secondary Effectiveness)
+5 moreOther study objectives
Incidence of Persistent Post-Concussion Symptoms (PPCS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Concussed youth at risk for prolonged symptomsExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,602 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
651,982 Total Patients Enrolled
Daniel J Corwin, MD, MSCEPrincipal InvestigatorChildren's Hospital of Philadelphia
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