Active Injury Management (AIM) After Pediatric Concussion
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      The proposed interventions of this study will determine the ideal discharge recommendations
      related to activity
    

Detailed description: 
      The investigators will conduct a phase II factorial clinical trial . The clinical trial will
      determine the benefit of prescribed low-intensity physical activity, behavioral management,
      or both, versus standard rest in acute (24-48 hrs) (Moderate Traumatic Brain Injury (mTBI)
      patients presenting to the pediatric Emergency Department (ED). Low-intensity physical
      activity (i.e.10,000 steps/day) will be prescribed and monitored in the first week
      post-injury with an actigraph (Fitbit®). Behavioral management will be prescribed using a
      phone app referred to as mHealth (mobile Health, specifically SuperBetter©) that promotes
      mental, physical, social, and emotional resilience. This randomized clinical trial will have
      four treatment groups: 1) activity, 2) mHealth, 3) activity+mHealth, 4) rest. The primary
      study outcomes will be symptoms and recovery by 14 days. All subjects will be assessed via
      phone at 3-5 days and in person at 14 days. The secondary outcomes will be to determine the
      influence of interventions on comprehensive aspects of physiologic recovery and
      patient-centered outcomes; including symptoms at 3 days, neurocognitive, vestibular/ocular
      motor impairment at 14 days, pediatric quality of life measures, time to symptom resolution,
      and return to normal activity via phone survey at 1 and 2 months. The investigators will
      assess symptom, quality of life, and recovery outcomes based on treatment group assignment
      for all subjects and high-risk subjects.
    

Intervention name(s): REST; ACTIVITY; mHEALTH
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The REST group will be recommended to return to school and light physical and cognitive activity as soon as tolerated- but no sooner than 48 hrs post-injury per current consensus recommendations. Notifications from the Fitbit app will be turned off, and step goal will be set at 500, to minimize positive feedback and reminders from achievement of activity goals; ACTIVITY group will be encouraged to engage in light to moderate physical activity with the goal of reaching 10,000 steps a day for one or more days during the first week. Subjects will be encouraged to engage in low-risk activities (e.g. walking). Subjects will be instructed to avoid activities that may increase risk of re-injury (e.g. bike riding, climbing, trampoline, sports). Fitbit notifications will be turned on and step goals will be set at 10,000. The simple goal of reaching 10,000 steps is clear to patients regardless of health literacy level, and real-time feedback provides continuous motivation.; mHEALTH group will be instructed to download the SuperBetter© app. In addition to the pre-programmed general resilience goals, research assistants will help the subjects to set personal mental, social, and emotional rehabilitation goals and milestones for acute recovery from mTBI (e.g. return to school for ½ the day, have an improvement in symptoms). These goals/milestones will give the patient an opportunity to celebrate the achievement of improvement from mTBI with the goal of generating a positive contextual frame for recovery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concussion