Mobile Health Tool for Concussions

Overseen By Melissa Godfrey

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Glasgow score <13, Lower extremity trauma, Prior concussion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mobile health tool designed to help young people recover more quickly from concussions. Known as mHealth assisted specialist access, the tool connects patients from the emergency department to specialized concussion care, aiming to improve access and reduce recovery time. The trial suits teens aged 13-18 who have recently had a concussion, visit the Children's Hospital of Philadelphia, and have a smartphone. Participants must be at moderate-to-high risk for prolonged symptoms following their concussion. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance concussion recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health tool is safe for concussed youth?

Research has shown that mobile health (mHealth) tools, like the one used in this study, are generally safe and easy to use. A review of studies found that mHealth technology can effectively track patient-reported outcomes without major safety concerns. People can use these tools to report symptoms and activities with little risk of negative effects.

In studies on remote monitoring for concussions, researchers found no major safety issues. Participants typically use chat technology to share daily symptoms, which helps them receive necessary care without physical procedures. This virtual approach reduces the chance of physical side effects.

Overall, mHealth technology has proven safe in similar situations, making it a promising option for improving access to care with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile health tool for concussions because it offers a new way to connect concussed youth at risk for prolonged symptoms with specialist care. Unlike traditional treatments that often involve in-person visits and lengthy wait times, this approach leverages mobile technology to provide more immediate access to healthcare professionals. This could lead to faster assessments and more personalized care, potentially reducing the duration and severity of concussion symptoms.

What evidence suggests that this mobile health tool is effective for concussions?

Research has shown that mobile health (mHealth) tools can assist people with traumatic brain injuries (TBI), such as concussions, in managing symptoms and improving recovery. In this trial, participants will use mHealth-assisted specialist access to track symptoms and manage care. Studies have found that digital tools for tracking symptoms in individuals with mild TBI are practical and can ease recovery. mHealth technology encourages daily reporting of symptoms and activities, facilitating faster access to appropriate care. This approach can lead to quicker recovery by ensuring timely specialist visits. Additionally, it offers an affordable and efficient way to manage patient care. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel J Corwin, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score >3/12)

Own a smartphone

Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion

Exclusion Criteria

Non-English speaking

Glasgow Coma Scale score <13

I have had an injury to my leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use remote patient monitoring (RPM) to report symptoms and activity daily, facilitating care hand-off from the emergency department to concussion specialty care

4 weeks

Daily virtual check-ins

Follow-up

Participants are monitored for persistent post-concussion symptoms and recovery milestones

Up to 90 days

Long-term follow-up

Evaluation of patient-defined and provider-defined appropriateness and acceptability of the intervention

Within 1 year of completing study procedures

What Are the Treatments Tested in This Trial?

Interventions

• mHealth assisted specialist access

Trial Overview 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.

How Is the Trial Designed?

Group I: Concussed youth at risk for prolonged symptoms Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

The study found a strong correlation (rs = 0.875) between symptoms reported via SMS text messaging and the conventional Post-Concussion Symptom Inventory (PCSI), indicating that text messaging is a valid tool for monitoring recovery in pediatric patients with mild traumatic brain injury (mTBI).

Retention rates for the SMS reporting were 74% until symptom resolution but dropped to 42% by the end of the study, suggesting that while text messaging is useful for short-term symptom tracking, it may not be the best long-term method for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Assessment of Acute Concussion Outcomes Through SMS Text (ConText Study). Schoenfeld, R., Drendel, A., Ahamed, SI., et al.[2023]

A survey of 145 pediatric care providers revealed that while 91% had treated concussion patients recently, many felt inadequately trained and lacked the necessary time to educate families about concussion diagnosis and management.

Most providers (96%) without specific decision support tools for concussion management expressed a need for such resources, indicating that improved education and standardized protocols could enhance care for concussion patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric providers' self-reported knowledge, practices, and attitudes about concussion. Zonfrillo, MR., Master, CL., Grady, MF., et al.[2022]

The HeadCheck app, developed in Australia, is designed to help parents recognize and manage pediatric concussions in children aged 5-18, providing tools for sideline checks and symptom monitoring.

By translating evidence-based guidelines into a user-friendly format, the app aims to improve community awareness and support safe recovery and return to activities for children after a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child concussion recognition and recovery: a community delivered, evidenced-based solution. Clarke, C., Anderson, V., Babl, FE., et al.[2022]

The Concussion Carepath, developed by a multi-disciplinary team, standardizes concussion management across three recovery phases (acute, subacute, and post-concussive) to improve patient outcomes and reduce healthcare costs.

The Cleveland Clinic Concussion (C3) app enhances clinical decision-making by systematically collecting objective data and guiding rehabilitation, ensuring timely referrals and effective communication among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Multi-Disciplinary Technology Enhanced Care Pathway for Youth and Adults with Concussion. Alberts, JL., Modic, MT., Udeh, B., et al.[2020]

Out of 1296 mobile health apps examined for managing Traumatic Brain Injury (TBI), only 53 were included in the study, with most focusing on TBI screening, education, and monitoring, particularly for sports-related concussions.

The evidence supporting the effectiveness of these mHealth interventions is limited, with only eight relevant studies identified, indicating that while mHealth has potential, its current application in TBI management is not well-established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health for Traumatic Brain Injury: A Systematic Review of the Literature and Mobile Application Market. Christopher, E., Alsaffarini, KW., Jamjoom, AA.[2020]

A web-based health app for managing post-concussion symptoms was found to be highly feasible, with nearly 100% adherence to clinical recommendations among the seven participants in the study.

Most patients reported improvements in their symptoms over time, indicating that this digital intervention, supported by a health coach, could be effective in enhancing recovery from concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an Interactive Coaching App to Enhance Post-concussion Outpatient Care. Curran, D., Lauzon, J., Quon, D., et al.[2022]

A study involving 56 adults with chronic traumatic brain injury (TBI) tested the use of mobile health (mHealth) apps to support participation in weight loss and brain health interventions over 12 months, showing that while the apps were easy to use, daily engagement varied significantly among participants.

The findings indicated that although the mHealth apps could enhance lifestyle interventions, their effectiveness was limited by low compliance and varying participant satisfaction, particularly during the COVID-19 pandemic, suggesting a need for improved delivery methods and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Pilot Testing of Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions in Chronic Traumatic Brain Injury. Juengst, SB., McShan, E., Conley, M., et al.[2022]

The mobile health (mHealth) system for tracking mood-related symptoms after traumatic brain injury (TBI) showed good compliance, with participants completing 73.4% of scheduled assessments over an 8-week period, indicating its feasibility for real-world use.

Participants reported high satisfaction with the smartphone application, scoring an average of 6.3 out of 7, and the assessments conducted via the app correlated strongly with traditional telephone interviews, validating the use of this technology for monitoring mood symptoms in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot feasibility of an mHealth system for conducting ecological momentary assessment of mood-related symptoms following traumatic brain injury. Juengst, SB., Graham, KM., Pulantara, IW., et al.[2019]

The SMART mHealth app was used by adolescents with mild traumatic brain injuries (mTBIs) for an average of 9 days over a month, indicating a moderate level of engagement with the symptom monitoring and educational modules.

Factors such as higher parental income, the presence of comorbid ADHD, and a coping style focused on emotional engagement were associated with increased usage of the app, suggesting that socioeconomic and psychological factors influence recovery management in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usage Patterns of an mHealth Symptom Monitoring App Among Adolescents With Acute Mild Traumatic Brain Injuries. Schmidt, M., Babcock, L., Kurowski, BG., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05741411

NCT05741411 | Facilitating Access to Specialty Treatment 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7926536/

Use of mHealth Technology for Patient-Reported ... The purpose of our scoping review was to describe the current use of mHealth technology for long-term assessment of patient-reported outcomes in ...

3. withpower.com withpower.com/trial/mobile-health-tool-for-concussions-25c34

Mobile Health Tool for Concussions Research shows that mobile health (mHealth) tools can help manage symptoms and improve recovery for people with traumatic brain injuries (TBI), including ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/02688697.2024.2346564

Digital health interventions for remote follow-up after mild ... Using digital tools to monitor and screen mild TBI patients for persistent symptoms is feasible. This could be a scalable, cost-effective, and convenient ...

5. researchprotocols.org researchprotocols.org/2025/1/e67675

Remote Digital Health Interventions to Support the Physical ... Objective: This review aims to identify DH interventions that support the physical, functional, or psychological rehabilitation of patients who ...

6. pediatrics.jmir.org pediatrics.jmir.org/2024/1/e53186/

Response Rate Patterns in Adolescents With Concussion ... Response Rate Patterns in Adolescents With Concussion Using Mobile Health and Remote Patient Monitoring: Observational Study. Response Rate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9529313/

Remote Follow-Up Technologies in Traumatic Brain Injury Motivations for outcome data collection in TBI are threefold: to improve patient outcomes, to facilitate research, and to provide the means and ...