Active Injury Management (AIM) After Pediatric Concussion

Not Applicable

Completed

• Conditions: Brain Concussion
• Interventions: Behavioral: mHEALTH; Behavioral: REST; Behavioral: ACTIVITY

• Registration Number: NCT03869970
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-06-11
• Primary Completion: 2023-06-22
• Study Completion: 2023-08-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth	mHEALTH	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.
Rest	REST	Discharge instructions focused on 24 - 48 hours of rest then symptom guided activity, Fitbit monitored.
Activity	ACTIVITY	Low intensity activity regardless of symptoms using their Fitbit to measure said activity with goals (eg. 10,000 steps/ day.
Both Activity and mHealth	mHEALTH	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).
Both Activity and mHealth	ACTIVITY	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).

Primary Outcome Measures

Name	Time	Method
Change in Post-Concussion Symptoms Scale (PCSS)	Day 0, Day 10-14	Post-concussive symptoms at 14 days will be assessed using the Post-Concussion Symptom Scale (PCSS). We chose the 22-item PCSS as it is commonly used and would ensure consistency in longitudinal comparisons. The PI has validated PCSS administration via phone. The PCSS comprises 22 self-reported symptoms (e.g., dizziness headache) rated on a scale from 0 (none) to 6 (severe). PCSS score of ≤ 7 will be defined as symptom recovery. The PCSS takes 5 min to complete.
Fitbit Flex 2 Actigraph	Day 0-14	The Fitbit Flex 2 Actigraph will be distributed from the ED for all subjects in the study. Fitbit Actigraphs have been utilized in over 300 published studies. The Fitbit Flex 2 device to be worn by all subjects will provide objective activity metrics including measures of physical activity (e.g., number of steps per day, active minutes, distance traveled) and sleep (e.g., time to fall asleep, time sleeping, restless time). The Fitbit Flex 2 has a up to 5 days of battery life (device reminds subjects when battery life is low). The device 5 LEDs can be utilized to remind subjects to move, remind of current step goals, and celebrate when the goal is met. These features will be activated for subjects in the ACTIVITY groups. These data will be extracted directly from each device through Fitbit's API (Application Programming Interface. Allows devices to communicate with other select devices) system. These data will be collected in the first 14 days postinjury.
Change in Pediatric Quality of Life Measures (PedsQL)	Day 0, Day 10-14,	We will assess health-related quality of life at 14 days using the PedsQL, a validated tool that has been used in healthy children and adolescents and those with acute and chronic health conditions. PedsQL has been demonstrated to show differences between subjects with persistent symptoms and those without up to 12 weeks post-concussion. The PedsQL measures have reliability and validity in assessing and comparing health-related quality of life scores between groups. They are agespecific and can be administered to parents and children and have been used to assess functional outcomes over time. The inventory includes 23 items rated from 0 (never) to 4 (almost always) and takes less than 5 min to complete.

Secondary Outcome Measures

Name	Time	Method
Symptom Tracking Assessment for Concussion (STAC) application	Day 0-14	The mobile application used in this study features an adaptive assessment of post-concussive symptoms utilizing the Post Concussive Symptom Survey (PCSS), which presents a narrow symptom list that adapts to focus on symptoms reported by the subject on previous assessments. Additional data to be collected will include: a report of cognitive and social activity, a subjective estimate of most active time of day (for validation against Fitbit data), times of day not wearing Fitbit, and the degree to which symptoms were exacerbated by activities. We have shown that the app is used by most subjects and that self-reported physical activity levels in this app show reductions similar to what we have seen with the Fitbit.
Immediate Post-Concussion Assessment and Cognitive Test (ImPACT)	Day 0, Day 10-14,	The Immediate Post-Concussion Assessment and Cognitive Test (ImPACT) computerized test will be used to assess neurocognitive function. The ImPACT test assesses attention processes, visual working memory, verbal recognition memory, reaction time, visual processing speed, numerical sequencing ability, and learning. These modules are aggregated into four composite scores: verbal and visual memory, motor processing speed, and reaction time. The sensitivity of ImPACT is 81.9%, and the specificity is 89.4%. Research on the validation and test re-test reliability of ImPACT is reported elsewhere. The PI has validated ImPACT in the pediatric emergency department in several previous studies. The ImPACT test takes 30 min to complete (including the PCSS)
International Activity Questionnaire (IPAQ)	Day 0, Day 10-14, Day 30, Day 60	Pre-injury activity level will be assessed in order to determine if discharge instructions lead to a decrease in post-injury activity level. To do this, we will utilize the International Activity Questionnaire (IPAQ). This is a validated tool to assess recall of average activity level and intensity over the preceding 7 days. It was chosen because it is brief and can be either self-administered or administered via structured phone interview. Activity levels can be expressed as categorical variables (Low, medium, high activity levels) or a continuous variable (MET-min/ week). We will also include the cognitive activity assessment used by Brown and colleagues. This measure assesses (on a scale of 1-4) the average level of cognitive activity including tests, reading, homework, texting, and video games during the past 7 days. The combined IPAQ and cognitive activity assessment take 5 min to complete.
Vestibular/Ocular Motor Screen (VOMS)	Day 0, Day 10-14,	We will assess vestibular/ocular motor impairment using the Vestibular/Ocular Motor Screen (VOMS) The VOMS assesses: 1) smooth pursuits, 2) horizontal and vertical saccades, 3) convergence, 4) horizontal and vertical vestibular ocular reflex and 5) visual motion sensitivity. Subjects verbally rate on a scale of 0 (none) to 10 (severe) changes in headache, dizziness, nausea and fogginess symptoms compared to their pre-assessment state following each VOMS assessment to assess symptom provocation. Convergence is assessed via symptom report and near point of convergence (NPC). NPC values \> 5 cm are considered abnormal. The VOMS takes 5 min to administer.
Brief Symptom Inventory-18 (BSI-18)	Day 3-5, Day 30, Day 60	The Brief Symptom Inventory (BSI) gathers patient reported data to assess psychological distress and psychiatric disorders. It tests three primary symptom dimensions (Depression, Anxiety, and Somatization) and is designed to assess changes throughout treatment. The BSI-18 asks 18 items are rated on a 5-point rating scale, 0 (Not at all) to 5 (Extremely). It is scored on the three primary symptoms dimensions and an overall Global Severity Index. Our research team has utilized the BSI-18 in the ED setting. The BSI-18 takes 4 minutes to complete.
Screen Time Assessment	Day 0 - 14	Screen Media Use and Internet Use (Screens) REF; Measures of screen time and internet use. Assess screen media use items: * Amount of time in screen use; * Assess internet use; * 5 items; * 8 point scale (1 = definitely disagree to 8 = definitely agree) Primary metric = Mean scores hours of screen media use and internet use
Modified Balance Error Scoring System (mBESS)	Day 0, Day 10-14,	We will assess balance using the modified Balance Error Scoring System (mBESS), a costeffective way to objectively assess balance. The test consists of three stance conditions (double leg, single leg, tandem) performed on firm flooring. In all stances, errors are recorded as the quantitative measurement of postural stability. Performance is scored by adding the error points according to the mBESS for each of the three trials. Trials are incomplete if subjects do not sustain the stance position for longer than 5 seconds. In this case, a standard maximum score of 10 is assigned for the trial. The mBESS takes 5 min to administer.

Trial Locations

Locations (2)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States