Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05741411

Conditions

Mild Traumatic Brain Injury

Concussion, Mild

Concussion, Severe

Concussion, Intermediate

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

RPM-assisted specialist access

Study Details

Brief summary:

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.

Conditions

Mild Traumatic Brain Injury

Concussion, Mild

Concussion, Severe

Concussion, Intermediate

Study ID

NCT05741411

Start date

Mar 11, 2024

Status verified date

May, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria for concussed subjects:

  • Males and females age 13 - 18
  • Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury
  • Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion
  • Own a smartphone
  • Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score >3/12)

Exclusion Criteria for concussed subjects:

  • Glasgow Coma Scale score <13
  • Lower extremity trauma
  • A prior concussion within 1 month
  • Non-English speaking
  • Admission to the hospital at the initial head injury visit
  • Previously enrolled in the study
  • Inability to complete study procedures.

Inclusion Criteria for parents:

  • Child meets the study eligibility criteria

Exclusion Criteria for parents:

  • Non-English speaking

Inclusion Criteria for providers:

  • ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy

Exclusion Criteria for providers:

  • Non-English speaking

Study Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Concussed youth at risk for prolonged symptoms

Interventions

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.

Primary outcome measure

  • Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness) [ Time Frame: 28 days from injury ]
  • Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation) [ Time Frame: 28 days from injury ]

Central Contacts and Locations

Central contacts

Melissa Godfrey

267-425-0386godfreym2@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniel Corwin, MD,MSCE

215-327-2306corwind@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • mobile health
  • emergency department
  • persistent post-concussion symptoms
  • remote patient monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-05-22.