AzTrials
AzTrials

Mild Traumatic Brain InjuryNCT05741411

Facilitating Access to Specialty Treatment

A study testing RPM-assisted specialist access in people with Mild Traumatic Brain Injury and Concussion, Mild, run by Children's Hospital of Philadelphia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 13 to 18 years
What is being tested?
RPM-assisted specialist access
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteUnited States
Study dates
11 Mar 2024to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Inability to complete study procedures.
  • Non-English speaking
  • Non-English speaking

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa Godfrey contact

267-425-0386

godfreym2@chop.edu

United States1 site, 1 recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Daniel Corwin, MD,MSCE, 215-327-2306, corwind@chop.edu

    Recruiting

Other trials in United States

About this study

Official title: Utilizing Mobile Health to Expedite Access to Specialty Care for Youth Presenting to the Emergency Department With Concussion at Highest Risk of Developing Persisting Symptoms

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.

Being tested
RPM-assisted specialist access
Keywords
mobile health, emergency department, persistent post-concussion symptoms, remote patient monitoring
Medical subject headings
Brain Concussion, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RPM-assisted specialist accessOther

    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.

Study groups in NCT05741411
Study groupRoleWhat they receive
Concussed youth at risk for prolonged symptomsExperimentalNot described
Receives: Other: RPM-assisted specialist access

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 days from injury

  2. 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

    Measured: 28 days from injury

Secondary outcomes (8)

  1. 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

    Measured: 28 days from injury

  2. Days until return to symptoms baseline (Secondary Effectiveness)

    Number of days from injury whereby patient-reported symptoms meets pre-injury baseline levels

    Measured: Up to 90 days from injury

  3. Days until clearance (Secondary Effectiveness)

    Number of days from injury until patient is fully cleared for full activity by a medical provider

    Measured: Up to 90 days from injury

  4. Days until return to school (Secondary Effectiveness)

    Number of days from injury until patient is able to return to full time school without accommodations

    Measured: Up to 90 days from injury

  5. 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

    Measured: 28 days from injury

  6. Patient-defined quantitative appropriateness (Secondary Implementation)

    Mean System Usability Score out of 100 with >=70 defined as acceptable appropriateness

    Measured: Within 1 year of completing study procedures

  7. Patient-defined qualitative appropriateness (Secondary Implementation)

    Themes from semi-structured interviews with patients related to intervention appropriateness will be identified

    Measured: Within 1 year of completing study procedures

  8. Provider-defined qualitative acceptability (Secondary Implementation)

    Themes from semi-structured interviews with providers related to intervention acceptability will be identified

    Measured: Within 1 year of completing study procedures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start11 Mar 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single group intervention arm compared to historical controls
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741411
Sponsor's protocol ID
22-019755
Other IDs
K23NS128275
Status last verified
May 2026
First submitted
14 Feb 2023
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.

    PubMed 26954410

  • Corwin DJ, Arbogast KB, Haber RA, Pettijohn KW, Zonfrillo MR, Grady MF, Master CL. Characteristics and Outcomes for Delayed Diagnosis of Concussion in Pediatric Patients Presenting to the Emergency Department. J Emerg Med. 2020 Dec;59(6):795-804. doi: 10.1016/j.jemermed.2020.09.017. Epub 2020 Oct 7.

    PubMed 33036827

  • Master CL, Master SR, Wiebe DJ, Storey EP, Lockyer JE, Podolak OE, Grady MF. Vision and Vestibular System Dysfunction Predicts Prolonged Concussion Recovery in Children. Clin J Sport Med. 2018 Mar;28(2):139-145. doi: 10.1097/JSM.0000000000000507.

    PubMed 29064869

  • Desai N, Wiebe DJ, Corwin DJ, Lockyer JE, Grady MF, Master CL. Factors Affecting Recovery Trajectories in Pediatric Female Concussion. Clin J Sport Med. 2019 Sep;29(5):361-367. doi: 10.1097/JSM.0000000000000646.

    PubMed 31460948

  • Wiebe DJ, Nance ML, Houseknecht E, Grady MF, Otto N, Sandsmark DK, Master CL. Ecologic Momentary Assessment to Accomplish Real-Time Capture of Symptom Progression and the Physical and Cognitive Activities of Patients Daily Following Concussion. JAMA Pediatr. 2016 Nov 1;170(11):1108-1110. doi: 10.1001/jamapediatrics.2016.1979. No abstract available.

    PubMed 27617669

  • Corwin DJ, Orchinik J, D'Alonzo B, Agarwal AK, Pettijohn KW, Master CL, Wiebe DJ. A Randomized Trial of Incentivization to Maximize Retention for Real-Time Symptom and Activity Monitoring Using Ecological Momentary Assessment in Pediatric Concussion. Pediatr Emerg Care. 2023 Jul 1;39(7):488-494. doi: 10.1097/PEC.0000000000002870. Epub 2022 Nov 3.

    PubMed 36730797

  • Corwin DJ, Godfrey M, Arbogast KB, Zorc JJ, Wiebe DJ, Michel JJ, Barnett I, Stenger KM, Calandra LM, Cobb J, Winston FK, Master CL. Using mobile health to expedite access to specialty care for youth presenting to the emergency department with concussion at highest risk of developing persisting symptoms: a protocol paper for a non-randomised hybrid implementation-effectiveness trial. BMJ Open. 2024 Jun 19;14(6):e082644. doi: 10.1136/bmjopen-2023-082644.

    PubMed 38904136

Questions about this trial

What is this clinical trial studying?

A study testing RPM-assisted specialist access in people with Mild Traumatic Brain Injury and Concussion, Mild, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa Godfrey (267-425-0386, godfreym2@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness) (time frame: 28 days from injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05741411, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in