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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment mHealth assisted specialist access, Remote Patient Monitoring (RPM), Mobile Health (mHealth) Intervention for concussions?

Research shows that mobile health (mHealth) tools can help manage symptoms and improve recovery for people with traumatic brain injuries (TBI), including concussions. For example, mHealth apps have been used to track mood-related symptoms and support healthy lifestyle changes in TBI patients, suggesting they could be effective in managing concussion symptoms as well. ^{1 2 3 4 5}

Is the Mobile Health Tool for Concussions safe for humans?

The available research on mobile health tools for concussions, such as apps for symptom monitoring and management, does not report any specific safety concerns. These tools are generally used to help track symptoms and provide guidance, and they have been tested with users as part of their development process. ^{3 4 5 6 7}

How is the mHealth assisted specialist access treatment for concussions different from other treatments?

The mHealth assisted specialist access treatment for concussions is unique because it uses mobile health technology to provide remote patient monitoring and guidance, helping patients and caregivers manage concussion symptoms and recovery through apps that offer symptom tracking, education, and personalized care plans. This approach is different from traditional treatments as it leverages technology to facilitate communication and decision-making, ensuring timely and efficient care. ^{1 3 5 8 9}

Research Team

Daniel J Corwin, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pilot feasibility of an mHealth system for conducting ecological momentary assessment of mood-related symptoms following traumatic brain injury. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Pilot Testing of Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions in Chronic Traumatic Brain Injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mobile Health for Traumatic Brain Injury: A Systematic Review of the Literature and Mobile Application Market. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Usage Patterns of an mHealth Symptom Monitoring App Among Adolescents With Acute Mild Traumatic Brain Injuries. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Child concussion recognition and recovery: a community delivered, evidenced-based solution. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Assessment of Acute Concussion Outcomes Through SMS Text (ConText Study). [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric providers' self-reported knowledge, practices, and attitudes about concussion. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Multi-Disciplinary Technology Enhanced Care Pathway for Youth and Adults with Concussion. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of an Interactive Coaching App to Enhance Post-concussion Outpatient Care. [2022]