Online Treatment Recovery Assistance for Concussion in Kids

NCT05065099 | Unknown

• 1 other identifier: Pro00014094
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion; MTBI - Mild Traumatic Brain Injury

Keywords

Concussion; mTBI; Mild Traumatic Brain Injury; Mobile Application; Symptom Monitoring; Pediatric; Children; Healthcare Provider Support

Outcome Measures

Primary Outcomes (3)

• The usability of the OnTRACK symptom monitoring system

  Patients, Parents, HCPs, and School Personnel in the intervention group will complete an OnTRACK App/Portal User Satisfaction Survey

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.

• The OnTRACK symptom monitoring system's effect on the HCP confidence in clinical decision-making, patient/ parent/ school confidence in carrying out management guidance

  Parents, HCPs, and School Personnel will each complete the Concussion Management Self-Efficacy Scale. Scores range from 0-120 on the Parent scale, 0-190 on the HCP scale, and 0-170 on the Teacher scale. Patients will complete the Progressive Activities of Cognitive Exertion scale- Self (score range: 0-170), with higher scores representing higher levels of confidence/self-efficacy for each of the four scales.

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.

• Communication with Patients, Parents, HCPs and School Staff

  A measure of satisfaction with the communication process between the family and HCP as well as between the HCP and school will be administered. Patient families, HCPs, and School Staff will complete the Communication Effectiveness Scale. Score ranges for the Patients/Parents scale is 0-90, HCP is 0-70, and School Staff is 0-80.

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.

Secondary Outcomes (5)

• Examine patient symptom recovery outcomes (self-reported)

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.

• Examine patient symptom recovery outcomes (parent reported)

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.

• Examine patient symptom recovery outcomes relating to school (self-reported)

  Participants will complete the survey when they are no longer symptomatic and are deemed recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.

• Examine patient symptom recovery outcomes relating to school (school-reported)

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.

• Change in knowledge associated with the educational videos

  Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.

Study Arms (2)

OnTRACK Intervention

EXPERIMENTAL

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.

Device: Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)

Treatment as Usual

NO INTERVENTION

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.

Interventions

Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK) 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.

Also known as: OnTRACK

OnTRACK Intervention

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• Creare, Inc.: collaborator

Study Sites (1)

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

Rockville, Maryland, 20850, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Gerard Gioia, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean R Allen, MA

CONTACT

(301)765-5458; drallen@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Neuropsychology

Model Details: We will employ a quasi-experimental mixed design occurring in two sequential phases, assigning the first half of the sample to the control (standard care) group, and the second half to the OnTRACK intervention group. The between-subjects variable will be assignment to intervention or control condition and the within-subjects variable being time (beginning of recovery, end of recovery) to address the specific aims of the study.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: October 1, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

US (1)