Development of a Concussion Management Platform for Children and Youth (Back2PlayApp)

McMaster University

Status: Completed

Conditions: Concussion, Brain

Treatments: Device: Back2Play App

Study type: Interventional

Funder types: Other

Identifiers

NCT05471791

CHRP 538798-19

Details and patient eligibility

About

This multi-centred, randomized controlled trial will evaluate the effectiveness of a pilot tested mobile device Application built to guide youth in recovery from concussion. The Back2Play App was developed based on the published and researched CanChild Return to Activity (RTA) and Return to School (RTS) guidelines, which outline graduated steps in returning to play and school for youth after a concussion. It is hypothesized that participants who use the App will have better outcomes from concussion, primarily less reinjury during the vulnerable period throughout their recover up to 3 months after concussion. They may also experience reduced frequency and severity of symptoms and recover more quickly from their concussion.

Full description

Children 10- 18 years of age will be recruited from Emergency departments in Hamilton, Ontario and Montreal, Quebec as well as from community physicians, school boards and sporting organizations. All participants will be randomized to either the App (intervention) group or to Usual care (control) group.

Those in the App group will be loaned an Apple watch (and iPhone if they don't have one). The App is designed to monitor self-reported symptoms and stages of recovery and combine these results with their activity and heart rate data collected by the watch. Notifications are sent through the App based on this data that may help youth adhere to the Return to Activity and Return to School (RTA/RTS) guidelines. Participants will fill out symptom surveys in the App up to 3 times daily, record their physical and cognitive activities and assign themselves a stage of recovery; RTA 1-6, RTS 1-5. The homepage of the App reminds them of what stage they are in of RTA and RTS as well as how much light, moderate and vigorous activity is encouraged for their individual stage of recovery. They will receive notifications about activity level and heart rate if these go outside the recommended limits. App users will also receive motivational statements and encouragement.

The control group will receive usual care with the approach provided in health care systems in their community. This often involves a handout with some type of graduated rest and return to play advice. These participants will complete the initial Post Concussion Symptom Scale at their entry into the study and will be sent daily symptom and activity surveys by our secure data capture system (REDCap) to complete. They will also be asked to self-select their stage of concussion recovery daily for both activity and school.

All participants will be scheduled for a zoom interview after their symptoms are gone, or 3 months after enrolling for those who do not achieve full recovery during the study. They will be asked questions about: 1) their understanding and experience with concussion recovery, 2) whether they experienced another head injury and 3) if those who used the App liked it and found it helpful. 3 months after study completion, participants will receive another survey asking if they have experienced any additional head injuries. Those using the App will be given the System Usability Scale (SUS) to objectively rate the App for potential future commercialization.

All data will be analyzed as discussed in the study protocol. Data may also be used fill in the architecture of a machine learning algorithm running in the background of the Back2Play App to use in predicting RTA/RTS stages for participants in future iterations of the App.

Enrollment: 181 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diagnosed concussion
• symptomatic
• within 4 weeks of diagnosis

Exclusion criteria

• developmental delay
• significant brain injury requiring resuscitation, admission to PCCU or surgical intervention
• multisystem injury

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

App group

Experimental group

Description:

Participants will use the Back2Play App to support them in following the guidelines for recovery from concussion

Treatment:

Device: Back2Play App

Usual Care

No Intervention group

Description:

Participants will receive usual care which often means they are provided concussion recovery guidelines in handout format and receive whatever follow up is deemed necessary by treating physician