Concussion, Brain
Conditions
Keywords
youth or children, mHealth
Brief summary
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.
Detailed 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.
Interventions
DEVICEBack2Play App
This App uses the Apple watch to monitor activity level and heart rate and combines this with self reported symptoms and stage of recovery to send notifications, suggestions and provide resources to help participants adhere to the guidelines.
Sponsors
Canadian Institutes of Health Research (CIHR)
Natural Sciences and Engineering Research Council, Canada
McMaster Children's Hospital
Montreal Children's Hospital of the MUHC
Hamilton-Wentworth Catholic District School Board
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control trial comparing treatment (use of mobile App) to usual care
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-injury | Surveyed 3 months after completion of study (6 months maximum from enrollment) | Survey-report on whether another concussion has occurred. Yes/No response |
| Change in number and severity of Post-concussive symptoms (PCSS) | Throughout the study until recovered or up to a maximum of 3 months after enrolment | Daily surveys of 22 concussion symptoms (1symptom/0 no symptoms) for # of symptoms. Included in these surveys is report of symptom changes (gone, better, same or worst) that will help to evaluate changes by stage of recovery and over the course of recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery from concussion | Through study completion, an average of 1 month, up to 6 months post-enrollment | Measurement of time from injury to when youth have recovered (return to activity stage 6/return to school stage 5) |
| System Usability Scale (SUS) (for the App group only) | upon completion of study (max 3 months post enrollment) | 10 item questionnaire using a Likert scale with five response options for measuring usability of a system (App) 1=strongly disagree 5= strongly agree; Scores are converted to an overall percentage with 70% and above a good score |
Countries
Canada
Outcome results
None listed