An interventional study of RPM-assisted specialist access in Mild Traumatic Brain Injury, Concussion, Mild and Concussion, Severe, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Other
The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 210 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for concussed subjects:
Exclusion Criteria for concussed subjects:
Inclusion Criteria for parents:
Exclusion Criteria for parents:
Inclusion Criteria for providers:
Exclusion Criteria for providers:
Other: RPM-assisted specialist access
Participants will be prompted to report current symptoms and activity once a day via remote patient monitoring chat technology for up to 28 days following injury. Patients with either escalating or plateauing symptoms will be flagged, with an electronic alert sent via the electronic health record to a nurse navigator. The nurse navigator will have access to the symptom data and facilitate scheduling an in person or telehealth specialist visit as indicated. Symptoms will continue to be monitored through the 28-day acute study period with additional clinical visits occurring according to clinical need.
Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)
Persistence of at least 3 concussion-like symptoms above the pre-injury state beyond 28 days from injury, defined as a positive difference between patient-reported symptoms and the perceived pre-injury symptom rating
Time frame: 28 days from injury
Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation)
Among those participants who flag to see a specialist, at least 1 interaction with a specialty provider either in person or via telehealth during the acute study period
Time frame: 28 days from injury
Modeling of PPCS (Secondary Effectiveness)
Multivariate logistic regression evaluating the effect on the incidence of PPCS of socio-demographic and neighborhood-level economic variables, including race, ethnicity, sex, insurance, mechanism of injury, and child opportunity index, as well as known factors associated with PPCS, including age, concussion history, and co-morbid conditions
Time frame: 28 days from injury
Days until return to symptoms baseline (Secondary Effectiveness)
Number of days from injury whereby patient-reported symptoms meets pre-injury baseline levels
Time frame: Up to 90 days from injury
Days until clearance (Secondary Effectiveness)
Number of days from injury until patient is fully cleared for full activity by a medical provider
Time frame: Up to 90 days from injury
Days until return to school (Secondary Effectiveness)
Number of days from injury until patient is able to return to full time school without accommodations
Time frame: Up to 90 days from injury
Modeling of fidelity (Secondary Implementation)
Multivariate logistic regression evaluating the effect on fidelity of socio-demographic and neighborhood-level economic variables, including race, ethnicity, sex, insurance, mechanism of injury, and child opportunity index
Time frame: 28 days from injury
Patient-defined quantitative appropriateness (Secondary Implementation)
Mean System Usability Score out of 100 with \>=70 defined as acceptable appropriateness
Time frame: Within 1 year of completing study procedures
Patient-defined qualitative appropriateness (Secondary Implementation)
Themes from semi-structured interviews with patients related to intervention appropriateness will be identified
Time frame: Within 1 year of completing study procedures
Provider-defined qualitative acceptability (Secondary Implementation)
Themes from semi-structured interviews with providers related to intervention acceptability will be identified
Time frame: Within 1 year of completing study procedures
Plan to share: No
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