Clinical trial NCT05065099: Online Treatment Recovery Assistance for Concussion in Kids
Official title: OnTRACK: Mobile Application for Pediatric Post-Concussion Patient Management - Phase 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion
MTBI - Mild Traumatic Brain Injury
Keywords: Concussion
mTBI
Mild Traumatic Brain Injury
Mobile Application
Symptom Monitoring
Pediatric
Children
Healthcare Provider Support
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Creare, Inc.
First posted: 2021-10-01
Enrollment: 408
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The usability of the OnTRACK symptom monitoring system
timeFrame: 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.
measure: The OnTRACK symptom monitoring system's effect on the HCP confidence in clinical decision-making, patient/ parent/ school confidence in carrying out management guidance
timeFrame: 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.
measure: Communication with Patients, Parents, HCPs and School Staff
timeFrame: 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:
measure: Examine patient symptom recovery outcomes (self-reported)
timeFrame: 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.
measure: Examine patient symptom recovery outcomes (parent reported)
timeFrame: 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.
measure: Examine patient symptom recovery outcomes relating to school (self-reported)
timeFrame: 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.
measure: Examine patient symptom recovery outcomes relating to school (school-reported)
timeFrame: 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.
measure: Change in knowledge associated with the educational videos
timeFrame: 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.
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Safe Concussion Outcome Recovery & Education (SCORE) Clinic at Children's National Hospital
state: Maryland
Study officials:
affiliation: Children's National Research Institute
name: Gerard Gioia, PhD
role: PRINCIPAL_INVESTIGATOR
References: