Online Treatment Recovery Assistance for Concussion in Kids

NCT ID: NCT05065099

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-12-31

Brief Summary

The investigators propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI). The platform includes a mobile application (app) for the patients and their care team (parents, teachers, coaches, etc.), a database server, and a decision support dashboard for healthcare providers. The OnTRACK app prompts the patient to report post-concussion symptoms across recovery in two distinct but equally important ways: a weekly cross-recovery graded symptom ratings to track overall recovery progress, and short-term daily dynamic exertional symptom responses to guide tolerable daily activity. Teachers and parents and other authorized members of the patient care team also report patient progress when prompted. Beyond symptom reporting, the app provides access to education in the form of short multimedia clips that cover various topics related to concussion recovery based on the PACE (Progressive Activities of Controlled Exertion) model. Using several large existing datasets on recovery trajectories, the serial symptom reports indicate (a) level of symptom severity, change over time, and whether recovery is following a typical or atypical pattern. The healthcare provider is regularly updated regarding recovery progress and, if an atypical pattern is reported, he/she receives an alert to assess further and consider referral for additional treatment. To guide daily recovery, OnTRACK uses empirically-derived algorithms to determine when the level of symptom exacerbation reaches a certain threshold, delivering an alert to the healthcare provider who can give feedback to the child to manage daily activities and reduce disruptive symptoms. The primary goal of the OnTRACK system is to afford the healthcare provider, patient, and family greater confidence with data-driven decisions upon which to follow evidence-based treatment guidelines and to improve communication between family and provider.

Detailed Description

The investigators will study the usability of a smartphone app (Online Treatment Recovery Assistant for Concussion in Kids, OnTRACK), its effect on provider management confidence, and communication plus a preliminary analysis of the benefits on patient recovery outcomes. The study will recruit 126 children, parent, school staff triads (n=378) along with their healthcare provider (HCP) including 22 primary care from the CN Pediatric Health Network and 8 specialists from the CN Safe Concussion Outcome, Recovery & Education (SCORE) clinics and Neurology clinics. The participants will track and monitor the child's symptoms and respond to HCP guidance over the course of recovery (up to 12 weeks), employing evidence-based algorithms related to recovery progress. The investigators hypothesize that the HCP will experience: (1) positive satisfaction in using the app, (2) increased confidence in their management guidance, and (3) increased communication with patients, families and school staff when using the OnTRACK app as compared to a control group who receives standard treatment without the OnTRACK app. The investigators further hypothesize that in using the OnTRACK app as compared with control group, patients, parents and school personnel will report: (1) positive satisfaction in using the app, (2) increased confidence in their symptom management, and (3) increased communication with the HCP. Additionally, the investigators hypothesize that the OnTRACK educational videos will be rated as useful and improve the understanding of the patient, parent and school regarding concussion and its management. Finally, the investigators hypothesize that patients will develop a better understanding of the dynamics of their exertional symptoms as related to school and home activities by tracking their occurrence and learning productive strategies to manage them.

Conditions

Concussion; MTBI - Mild Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

OnTRACK Intervention

In the intervention condition, HCPs will be trained in the usage of the OnTRACK system.

They will be oriented to the educational videos, the symptom tracking, and the interpretation of the data that is provided by the patients and families, and the associated management strategies based on that data. Additionally, patients and parents will be trained to use the OnTRACK smartphone app on their phone from diagnosis to recovery (or 12 weeks if not recovered), including daily exertional monitoring symptom ratings and use of the educational videos. School personnel will be introduced to the OnTRACK app and the data summary features in the school dashboard and the associated supports that can be provided to the student based on that data.

Group Type: EXPERIMENTAL

Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)

Intervention Type: DEVICE

Patients and families will be provided the smartphone app on their personal mobile phone (Android, iPhone) or provided with a phone if they do not own one. The patients will view educational videos on concussion management, input their daily exertional status and weekly symptom status upon receiving pre-programmed notification prompts on their phone. Healthcare Providers will monitor symptom recovery via an HCP dashboard and make management recommendations using evidence-based algorithms regarding symptom recovery status. School personnel will monitor progress via a dashboard and provide targeted supports, they may also view educational videos on concussion management. Opportunities for communication between the HCP, parent/patient and school will be provided by the app.

Treatment as Usual

In the control condition, the HCP provides "usual/standard care" to the patients and parents as is the practice within the specific clinic. The OnTRACK app and the educational modules are not provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)

Patients and families will be provided the smartphone app on their personal mobile phone (Android, iPhone) or provided with a phone if they do not own one. The patients will view educational videos on concussion management, input their daily exertional status and weekly symptom status upon receiving pre-programmed notification prompts on their phone. Healthcare Providers will monitor symptom recovery via an HCP dashboard and make management recommendations using evidence-based algorithms regarding symptom recovery status. School personnel will monitor progress via a dashboard and provide targeted supports, they may also view educational videos on concussion management. Opportunities for communication between the HCP, parent/patient and school will be provided by the app.

Intervention Type: DEVICE

Other Intervention Names

OnTRACK

Eligibility Criteria

Inclusion Criteria

Healthcare providers (HCP) (n =28):

• Primary care practitioners and their clinical assistants (e.g., nurse, PA) (n = 22)
• Practitioners from the SCORE Concussion and Neurology clinics at Children's National (n = 6)

Patient/ Parent (n = 134 pairs):

• Children aged 8-17 years old
• Children who sustained a concussion within 7 days prior to visiting their primary care practice, and within 30 days of visiting the specialty clinics
• Children and parents must be fluent English speakers
• Children and parents must be agreeable to the study conditions, and able to provide informed assent/ parent consent

School Staff member (n = 134):

• Members of faculty at the school the patient attends
• Pre-selected by child/parent
• Fluent in English language
• Agreeable to study conditions, and able to sign consent forms

• Children/parents who's school will not participate will still be eligible to participate

Exclusion Criteria

• Children with significant developmental, cognitive, language, psychiatric, other neurological disease, or significant motor or visual impairments, specifically if they do not allow adequate comprehension of the study goals and materials

• Patients with pre-injury histories of developmental disorders (e.g., ADHD, LD), mild-moderate anxiety or mood disorders, and other medical diseases that are under control (e.g., asthma, diabetes, headaches, seizures) are all eligible to participate in the study
• Children who have suffered a severe prior brain injury or have had a prior concussion within the past 3 months
• Caregivers who have significant cognitive limitations
• Individuals with English-language comprehension limitations
• School staff who are unable to meet with the student on a regular basis to review the app information and/or complete the questionnaires during the workday

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creare, Inc.

INDUSTRY

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Gerard A. Gioia

Chief of Neuropsychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard Gioia, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Safe Concussion Outcome Recovery & Education (SCORE) Clinic at Children's National Hospital

Rockville, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dean R Allen, MA

Role: CONTACT

drallen@childrensnational.org

(301)765-5458

Facility Contacts

Dean R Allen, ma

Role: primary

drallen@childrensnational.org

301-765-5458

Other Identifiers

Pro00014094

Identifier Type: -

Identifier Source: org_study_id