Active Injury Management (AIM) After Pediatric Concussion

Medical College of Wisconsin

Status: Completed

Conditions: Brain Concussion

Treatments: Behavioral: REST; Behavioral: ACTIVITY; Behavioral: mHEALTH

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03869970

PRO00033221

Details and patient eligibility

About

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

Full 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.

Enrollment: 237 patients

Sex: All

Ages: 11 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of mTBI in the past 72 hours

Exclusion criteria

• Patients having conditions otherwise which limit physical activity or neurocognitive assessment
• Do not have a smart phone
• History of brain surgery or past moderate/severe TBI within the last 6 months,
• Substance abuse,
• Major psychiatric condition under ongoing treatment with medications,
• Vestibular disorder,
• Cardiac condition,
• Unable to provide consent/assent
• Previous enrollment in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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237 participants in 4 patient groups

Rest

Active Comparator group

Description:

Discharge instructions focused on 24 - 48 hours of rest then symptom guided activity, Fitbit monitored.

Treatment:

Behavioral: REST

mHealth

Active Comparator group

Description:

Use of the "resilience" application on a smart phone to assess daily symptoms over 14 days and follow a self directed, symptom guided return to physical activity. Also Fitbit monitored.

Treatment:

Behavioral: mHEALTH

Activity

Active Comparator group

Description:

Low intensity activity regardless of symptoms using their Fitbit to measure said activity with goals (eg. 10,000 steps/ day.

Treatment:

Behavioral: ACTIVITY

Both Activity and mHealth

Active Comparator group

Description:

This group will receive both interventions and utilize the "SuperBetter" app. Interventions will be integrated by having research assistants support the subject to set and physical activity goals and milestones to the subject's pre-programmed general resilience goals in the SuperBetter© app (e.g. take a 30 min walk, march in place for 5 minutes, increase my step count by 2000 today, achieve 10,000 steps today).

Treatment:

Behavioral: mHEALTH

Behavioral: ACTIVITY