Smart Phone Application for Postconcussion Symptom Reduction
Phase: NA
Conditions: Concussion
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
Project ID: IIR 13-196-1 
Smart Phone Application for Post-Concussion Symptom Reduction 
HSR&D 
Tracy Kretzmer, PhD, Principal Investigator 
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Abstract 
The proposed study will address a very important issue for the VA both currently and in the 
future -- the high percentage of OIF/OEF/OND Veterans who have been medically diagnosed 
with a mild traumatic brain injury (mTBI) and experience distressing symptoms. “Smart phone” 
mobile applications have become a primary source of information and communication among 
large percentages of Americans, especially those of the OIF/OEF/OND generation. The 
proposed study is a 4-year randomized control trial investigating the utility of an interactive, self-
management smartphone application, “Concussion Coach”, one of a suite of mobile applications 
developed by the VA. The primary goal of the proposed study is to evaluate the efficacy of 
Concussion Coach for improving clinical outcomes in those with a history of mTBI and to 
determine what aspects of Concussion Coach are most useful to Veterans.  An overarching 
goal of this line of research is to improve access among Veterans with mTBI who still have 
symptoms months to years after injury. 
The study will pursue the following objectives: 
(1) Evaluate the efficacy of Concussion Coach for improving clinical outcomes among recipients 
of Concussion Coach.   
(2) Determine the aspects of Concussion Coach most associated with positive outcomes. 
(3) Obtain qualitative information on factors associated with use of Concussion Coach or with 
deriving benefit from use of Concussion Coach that can be used to inform future modifications 
of the application and wide scale implementation. 
Design: 
Patients who meet eligibility criteria and consent to participate in the study are randomly 
assigned to one of two arms, either the Concussion Coach group, which will receive the 
Concussion Coach “Explorer” version either downloaded onto their own phone or via an iPod 
touch® given to them for this purpose, or the no mobile app Control group.   
Both groups are assessed in a pre/post intervention design and compensated for their time 
completing study questionnaires. During the 3 months that they are involved in the study, the 
intervention group is sent (via Concussion Coach) reminders to engage with the App. At the 
completion of the study, both groups are encouraged to download the App for their own 
personal use, with assistance from the study team if needed.  
In addition, individual interviews will be conducted with 10% of the Concussion Coach users to 
evaluate their satisfaction with Concussion Coach in terms of its ease of use, their perception 
and satisfaction with other TBI-related education received within the VA to date, barriers and 
facilitators to using Concussion Coach, and behavioral intention to use Concussion Coach in the 
future. 
Recruitment/data collection/status: 
 419 patients (93% of our goal) with a history of mild TBI and current symptom complaints have 
been recruited and enrolled thus far. Participants have been recruited from both the Tampa VA 

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(lead site) and the Bay Pines VA, and their respective outpatient clinics (CBOCs). The average 
age of our participants to date is 41.5; 91% are male and most (93.0%) sustained their mild TBI 
over one year ago. In addition, 24 participants have completed the recorded interviews. Study 
recruitment is ongoing. 
 
 

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List of Abbreviations 
CBOC  
Community Based Outpatient Clinic  
CPR  
Cardiopulmonary Resuscitation  
DoD  
Department of Defense  
OIF/ OEF/ OND  
Operations Iraqi Freedom, Enduring Freedom, New Dawn  
PCS  
Post-Concussion Symptoms 
PTSD 
Post-Traumatic Stress Disorder 
RCT 
Randomized Controlled Trial 
T1, T2 
Time 1, Time 2 
TBI 
Traumatic Brain Injury 
USF 
University of South Florida 
VHA 
Veterans Health Administration 
 

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Contents 
Protocol Title: ............................................................................................................................. 5 
1.0 
Study Personnel .............................................................................................................. 5 
2.0 
Introduction ..................................................................................................................... 7 
3.0 
Objectives ......................................................................................................................11 
4.0 
Resources and Personnel ..............................................................................................12 
5.0 
Study Procedures ...........................................................................................................12 
5.1     Study Design ...................................................................................................................12 
5.2      Recruitment Methods .....................................................................................................16 
5.3      Informed Consent Procedures ........................................................................................19 
5.4      Inclusion/Exclusion Criteria ............................................................................................21 
5.5      Study Evaluations ..........................................................................................................21 
5.6      Data Analysis .................................................................................................................26 
5.7      Withdrawal of Subjects ...................................................................................................28 
6.0 
Reporting ........................................................................................................................28 
7.0 
Privacy and Confidentiality .............................................................................................30 
8.0 
Communication Plan ......................................................................................................29 
9.0 
References .....................................................................................................................32 
 

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Protocol Title:  Smart Phone Application for Post-Concussion Symptom Reduction 
1.0 
Study Personnel 
Note: Tampa VA is the primary and coordinating site for this study.  Bay Pines is the 
other site.  Minneapolis will be considered a non-engaged site. (One of our co-
investigators is located there but the study will not be conducted there).  
Principal Investigator/Study Chair 
Tracy Kretzmer, PhD 813.558-3911 
Tampa VA/Univ. of South Florida 
Co-Investigators: 
Gail Powell-Cope, PhD, RN, FAAN (Co- Investigator). Dr. Powell-Cope is the Associate 
Chief for Research, Nursing Service, at the James A. Haley Veterans Hospital, and Director of 
the HSR&D COE in rehabilitation outcomes at the Tampa VA.  
Sharon Haire, MS (Co-Investigator) is a Speech Therapist for the outpatient Polytrauma 
Rehabilitation Center Network Site, Tampa VA.  
Peter Toyinbo, PhD (Statistician) is a biostatistician at the Tampa HSR&D/RR&D Center 
of Excellence (COE).  He also holds a position of adjunct assistant professor at the Department 
of Epidemiology and Biostatistics, University of South Florida.  
Emily King, PhD (Local Site Investigator, Bay Pines Site PI) is a Clinical 
Neuropsychologist at the Bay Pines VA.  
Zoe Proctor-Weber, PhD (Co-Investigator, Bay Pines Site) is a Clinical 
Neuropsychologist at the Bay Pines VA. 
           Tanya Harris, MD (Co-Investigator, Bay Pines Site) - Physical Medicine and 
Rehabilitation at Bay Pines VA. 
Tamara McKenzie-Hartman, PhD. (Research Associate, Tampa VA) is an experienced 
Research Associate 
Off-site Consultants/Co-Investigators (no access to data): 
Nina Sayer, PhD. (Consultant/Co-Investigator) is a Psychologist and Research Director 
for the Polytrauma and Blast-Related QUERI.   
NOTE: However, she will not have access to identifiable participant data and there 
are no study procedures taking place there. Minneapolis will therefore be considered a 
site that is not engaged in the study. 

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Collaborators: 
Kevin Kip, PhD, (Consultant) 
            Nitin Patel, MPH, (Consultant) 
Susan Horrigan, MA, (Bay Pines VA) is an experienced Recruiter/Study Coordinator. 
Barbara McKenzie, MA, (Tampa, VA) is an experienced Project Manager  
Padmaja Ramaiah, MSBME, (Tampa VA) is an experienced Research Assistant 
Angel Klanchar, MS, (Tampa VA) is an experienced Recruiter 
Lee Augello, Transcriptionist (Tampa VA) 
Blake Barrett, MSPH, (Tampa VA) is an experienced Data Manager 
Jemy Delikat, MOT, OTR/L (Tampa VA) Interviewer 
Heather Belanger, PhD. (Consultant) 
Sarah Bradley MA, Provisional CPH (Tampa VA) experienced Qualitative Data Manager 
 
2.0 
Introduction 
Traumatic Brain Injury (TBI) 
Unfortunately, TBI is a common injury among returning Veterans from OIF/OEF/OND; the 
majority of TBI is mild in severity.  Through meta-analytic study on mild TBI, we demonstrated 
that athletes tend to recover cognitively within the first 7 days following injury4 while most 
individuals recover completely within 3 months following a mild TBI.5  However, a significant 
percentage continues to complain of post-concussion symptoms (PCS). Though there are 
formal criteria (i.e., DSM, ICD-10) for the PCS syndrome, PCS symptoms are variable over time 
(i.e., some get better over time and some do not).6 As such, many argue that PCS is not actually 
a syndrome.7 In this document, the term PCS will be used to describe symptoms rather than 
specific diagnostic criteria. 
Mild TBI is a Common Health and Economic Problem – Approximately 80 to 90% of TBIs 
are classified as mild.8 Mild TBI has been recognized as a major public health concern with an 
annual worldwide incidence ranging from 100 to 550 per 100,000.9 The economic impact of mild 
TBI is substantial, accounting for about 44% of the 56 billion dollar annual cost of TBI in the 
United States;10 medical costs are 76% higher on average for individuals with a history of mild 
TBI than for those without.11 For those hospitalized following a mild TBI, up to 70% stay home 
from work for up to 6 months.12 Even for patients not admitted to the hospital, the economic 
burden of mild TBI is considerable with many patients not returning to work until 1 to 3 months 
post-injury and having reduced self-rated productivity for several months thereafter.12 In the 

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current military conflicts, the number surviving brain injuries is second only to those surviving 
orthopedic injuries.13 When compared to the overall population of service members discharged 
from the military, those who sustained a mild TBI are more likely to be discharged from the 
military for behavioral reasons.14  
Post-Concussion Symptoms or PCS – Immediately following a mild TBI, 80 to 100% of 
individuals will experience some PCS symptoms.15 In our own research, we found the 
prevalence of long-term (long after injury) symptoms to be about 18%,16 while others have 
reported 20 to 25%.17 18  PCS symptoms often occur without demonstrable structural changes to 
the brain19 or neuropsychological dysfunction.15 20 As we discuss in our review of the 
experimental neuroimaging literature,21 even more sensitive imaging modalities (e.g., fMRI) 
have yet to explain symptoms associated with mild TBI in a convincing way. PCS symptoms are 
not unique to mild TBI and are frequently reported in other medical conditions.22 23 As such, 
some authors argue that while neurological factors may play a role in the onset of PCS, 
psychological factors likely play a role in the maintenance of symptoms. These symptoms may 
be the result of, or exacerbated by, psychological mechanisms such as poor coping style.24 In a 
recent study, negative expectancies were predictive of PCS at 6 months.17 Depression and 
anxiety (including PTSD) correlate highly with symptoms25 26 and are predictive of symptoms at 
3 months post-injury.27 Many other risk factors are associated with PCS such as litigation 
status,28 older age, less education, lower levels of intellectual functioning, female gender, prior 
head injury, poor socioeconomic status, alcohol abuse, social difficulties, environmental stress, 
and multiple traumas. Finally, medical factors (e.g., pain) and sleep problems are significantly 
associated with PCS.29 30  Although PCS symptoms are not unique to TBI, they nevertheless 
have an independent association with mild TBI.31 32 Regardless of the cause, PCS symptoms 
are associated with poorer quality of life33 and have the potential to be costly to the military and 
VHA, both in terms of continued symptom complaints and healthcare utilization, as well as 
premature discharge from the military.  Finally, PCS can interfere with work and family life even 
a year or more post-injury.16 34 
Identification of Deployment-Related Mild TBI – Due to population screening within the VHA 
since 2007, increasing numbers of patients have been identified who sustained a mild TBI and 
are currently symptomatic (i.e., have multiple complaints of PCS symptoms). A question for 
VHA is how best to effectively manage and treat these patients. 
Misattribution of symptoms to a residual TBI when such symptoms are secondary to stress, 
chronic sleep deprivation, Post-Traumatic Stress Disorder (PTSD) or other factors can 
iatrogenically reinforce the misconception that these symptoms are permanent.35  
A growing body of literature demonstrates the role of expectation in both cognitive performance 
and rate of symptom complaint.  Simply drawing attention to the label “TBI” can cause increased 
symptom reporting and result in poorer cognitive performance.36-38 If there is an expectation of 
post-injury problems, then in at least some individuals, such symptoms are more likely to 
occur.37 39  In addition, since virtually everyone with a mild TBI experiences acute symptoms for 
minutes to hours, the mere presence of these symptoms can reinforce preexisting expectations 
and beliefs.  In contrast, if there is no expectation of ongoing symptoms, then few or no ongoing 

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symptoms are reported.36  Both brain dysfunction and expectation play independent and 
interactive causative roles.40   Given the current political climate and the emphasis on TBI as the 
“signature injury” of the war on terror, research regarding patient self-expectation is particularly 
pertinent.  Merely by screening individuals within the context of increased media attention on 
TBI, the stage is set for expectancies to exert an influence on the patient’s belief system and to 
attribute many or all difficulties to TBI.  In addition, there may be an inclination by the patient to 
attribute symptoms to TBI, rather than psychological diagnoses such as PTSD, given the 
perception that a physical brain injury is less “their fault” or under their control.  
 
Figure 1. Theoretical Model of PCS      
 
A Theoretical Model of PCS. 
Based on a thorough review of 
PCS literature, we posit a 
theoretical model of acute and 
chronic symptom etiology and 
maintenance, as depicted in 
Figure 1.40  Factors that are 
likely most modifiable are 
shaded light gray. 
  
Providing Education to 
Reduce PCS in Civilians -  
Psychoeducational interventions 
include giving patients information about common symptoms following mild TBI, typical time 
course of symptoms, expectancy effects, relation of symptoms to stress, and strategies for 
symptom management and reattribution. These educational interventions have been shown to 
result in significantly shorter average symptom duration and significantly fewer symptoms at 
follow-up in civilians.41 42 Several standardized, empirically supported treatment manuals are 
available.43 44 Even an early single session intervention can prevent the syndrome as effectively 
as traditional outpatient therapy.41 We have extensively reviewed the studies published to date 
with regard to non-pharmacological approaches to the treatment of PCS.45 The literature 
consistently demonstrates that psychoeducational interventions, with provision of education 
about mild TBI, typical recovery, and symptom management strategies are effective. However, 
as the existing literature is almost entirely civilian seen within days to weeks after injury, it is still 
unknown if Veterans with combat-related mild TBI seen months to years’ post-injury and post-
combat can benefit from this type of intervention. 
Only one study utilized a chronic population. Tiersky et al.46, studied patients with mild to 
moderate injuries who were an average of 5 years post-injury. Significant treatment effects for a 

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rehabilitation program consisting of psychotherapy and cognitive remediation were found for 
some psychological symptoms (e.g., anxiety and depression) but the treatment was much more 
involved than other studies that focused on acutely injured patients (i.e., 33 treatment sessions 
total). As such, it is currently unknown if brief psychoeducational interventions will be helpful in 
patients who are seen months to years after their injuries. The brief psychoeducational 
approach that has been successful with patients soon after injury has never been tested in a 
subacute or chronic sample. 
Mobile Technology 
Within VHA, nearly a third of returning Veterans referred for an evaluation following a positive 
screen for mild TBI fail to arrive at the facility (Cifu, personal communication). Lindley et al. 
found,47 in their analysis of mental health screening of OEF/OIF Veterans, that approximately 
40% of those referred for care do not attend even one appointment. Some of the barriers to care 
are likely logistical, such as lack of transportation. In response, the VA has been at the forefront 
of finding new and creative ways to reach Veterans, such as MyHealtheVet, telehealth, mobile 
medical clinics, and most recently, “smart phone” technology.   
Mobile phone applications have become a primary source of information and communication 
among many Americans, especially those of the OIF/OEF/OND generation. A Pew Research 
Center survey estimated that 79% of 18 to 29 year olds use mobile application technology.48 
Mobile phones now offer multiple functions such as calendar, photography, music, instant 
messages, video, and social networking. Furthermore, users can download applications 
(i.e.“Apps”) that serve a variety of functions. Smart phone technology is increasingly being used 
in medical settings49 and for the provision of health-related education, including CPR instruction, 
communication skills, diabetes self-management, sex education, and other uses. Many apps 
allow for patients to track symptoms and receive messages.  
The VA and Department of Defense are investing heavily in mobile technology. The VA has 
over 15 mobile apps in various stages of development to assist Veterans and their families with 
issues ranging from mild TBI to parenting.   Julia Hoffman, is the lead author of the VA’s new 
Concussion Coach, as well as the award-winning PSTD Coach.  
The VA’s Concussion Coach is an interactive, self-management tool designed to address 
the modifiable ‘causes’ of PCS identified in our theoretical model. Investigating the utility of 
the Concussion Coach smart phone application for increased self-management and PCS 
reduction is the primary focus of this study.  Concussion Coach, which is described in the 
Methods section, is based on an evidence-based review of the PCS intervention literature but 
delivers it via an innovative, interactive, self-management platform. Randomized controlled trials 
have demonstrated the effectiveness of a self-management approach to chronic disease in 
improving self-efficacy, physical and psychological health, and reducing health care utilization in 
patients with arthritis, lung disease, stroke, heart disease, and multiple sclerosis.1 2  We found 
no studies that applied a chronic disease self-management approach for treating PCS, though 
such an approach is clearly applicable given the longstanding presence of symptoms and 
multifactorial contributing predictors (many of which are potentially malleable), as outlined in our 
model above. 
 

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Interactive, computer-based patient education programs have demonstrated utility in a variety of 
different medical conditions.3 They draw on constructivist learning theories that highlight the 
importance of active self-paced learning. In a recent review, interactive computer-based patient 
education programs were found to be as effective or more effective than education provided by 
healthcare professionals in 7 of 8 studies3 in terms of various clinical outcomes, satisfaction, 
knowledge gain, and cost savings. Theories of self-management rely on social cognitive theory 
that posits behavior is influenced by personal factors, environmental factors, and behavior 
itself.50 51  Key personal factors include self-efficacy (or confidence in one’s ability), outcome 
expectancies, and mood. Beliefs that people have about themselves are key elements in the 
exercise of control and personal agency; individuals are viewed both as products and as 
producers of their own environments and of their social systems. Improved self-efficacy, 
expectancy effects, and improved mood, have all been linked to improved health outcomes 
across many different patient groups. We will attempt to answer the following research 
questions: 
 
Q1: Is Concussion Coach effective in improving PCS and psychological distress in those with a 
history of mild TBI? 
Q2: What are the moderators and mediators of the effectiveness of Concussion Coach?  
(a) Is comfort with technology related to efficacy of Concussion Coach? 
(b) Is perceived social support related to efficacy of Concussion Coach? 
Q3: Does use of Concussion Coach (a) increase Veterans’ knowledge about TBI and change 
Veterans’ attribution of symptoms from mild TBI to less “pathological” explanations (e.g., stress, 
post-deployment re-adjustment, or other causes), (b) increase Veterans’ self-efficacy in coping 
with symptoms?  
More broadly, are the effects of Concussion Coach on PCS  and psychological distress 
mediated through change (from T1 to T2) in Veterans’ perceptions and knowledge of the illness 
and in self-efficacy?  
Q4: What aspects of Concussion Coach are most associated with positive outcomes among 
recipients of Concussion Coach? Is more frequent use of specific components of Concussion 
Coach associated with greater improvement, relative to other components? 
Q5: What are the factors associated with use of Concussion Coach or with deriving benefit from 
use of Concussion Coach that can be used to inform future modifications of the application and 
wide scale implementation?  
3.0 
Objectives 
The proposed study is a 4-year randomized control trial investigating the utility of an interactive, 
self-management smartphone application, “Concussion Coach,” one of a suite of mobile 
applications developed by VA. The primary goal of the proposed study is to evaluate the 
efficacy of Concussion Coach for improving clinical outcomes in those with a history of mild 
traumatic brain injury (mild TBI) and to determine what aspects of Concussion Coach are most 

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useful to Veterans.  An overarching goal of this line of research is to improve access among 
Veterans with mild TBI who still have symptoms months to years after injury. 
Aim 1. Evaluate the efficacy of Concussion Coach for improving clinical outcomes 
among recipients of Concussion Coach.   
Hypothesis 1 (Primary Hypothesis): Patients randomized to receive Concussion Coach for 3 
months will have (a) lower Post-Concussion Symptom severity (PCS) and, (b) lower 
psychological distress, compared to patients randomized to a no intervention control group, 
after adjusting for baseline severity and other potential confounders. 
Aim 2. Explore mediation/moderation of Concussion Coach effects on clinical outcomes 
among recipients of Concussion Coach.   
Hypothesis 2: The effects of Concussion Coach on PCS (and psychological distress) will be 
greater for Veterans who have (a) greater comfort with technology at baseline than for those 
who are less comfortable; (b) greater social support at baseline than for those with less social 
support. 
Aim 3. Determine the aspects of Concussion Coach most associated with positive 
outcomes.  
Hypothesis 3: If Concussion Coach improves Veterans’ (a) knowledge about TBI and 
attribution of symptoms and/or (b) self-efficacy in coping with symptoms, Veterans will have less 
PCS and psychological distress. 
Aim 4. Obtain qualitative information on factors associated with use of Concussion 
Coach or with deriving benefit from use of Concussion Coach that can be used to inform 
future modifications of the application and wide scale implementation.  
Hypothesis 4:  More time spent on (a) Concussion Coach use, and (b) specific interactive 
components of Concussion Coach (i.e., the “tools” section) will be associated with lower PCS 
symptom severity after adjusting for baseline PCS values and potential confounders. 
Research Question 1:  What barriers prevent patients from using the Concussion Coach and 
from improving on PCS symptom severity? 
Research Question 2:  Are there facilitators that support Concussion Coach’s use and 
enhance its efficacy? 
4.0 
Resources and Personnel 
The study will be conducted at two sites – Tampa VA and Bay Pines VA.  Both sites will 
recruit from their primary hospitals, and also their respective CBOCs (outpatient clinics). 
The key personnel’s roles in the study are described in section 1.0. The only 
contractor is Vertical Product Development to create the explorer version of the App. 

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. 
• 
Include where and by whom the research will be conducted.  
• 
Provide a brief description of each individual’s role in the study.  Be sure to 
indicate who will have access to protected health information and who will be 
involved in recruiting subjects; obtaining informed consent; administering 
survey/interview procedures; and performing data analysis. 
• 
If applicable provide information on any services that will be performed by 
contractors including what is being contracted out and with whom. 
• 
If applicable provide information on any Memoranda of Understandings (MOUs) 
or Data Use Agreements (DUAs) that are being entered into including with whom 
and for what reason. 
5.0 
Study Procedures 
5.1 Study Design 
• 
Describe experimental design of the study.  Include sequential and/or 
parallel phases of the study, including durations, and explain which 
interventions are standard of care.   
• 
Include a description of how anticipated risk will be minimized and include 
an analysis of risk vs. potential benefit. 
• 
Provide description of the study population (delineate all categories of 
subjects – patients, providers, family members, employees, etc.). Include 
anticipated enrollment numbers 
• 
As applicable, provide information on any added protections for 
vulnerable populations.  
• 
If applicable include information on data. 
Patients who meet eligibility criteria and consent to participate in the study are randomly 
assigned to one of two arms, either the Concussion Coach group, which will receive the 
Concussion Coach “Explorer” version either downloaded onto their own smart phone or via an 
iPod touch® given them for this purpose or the no mobile app control group.  Study personnel 
will explain the purpose of the study, complete the informed consent process in person or over 
the telephone, obtain the random treatment assignment and introduce the participant to his/her 
baseline evaluator, if appropriate. The random assignment to intervention will be accomplished 
in blocks within each site. While small block sizes allow intervention group sizes to be very 
similar it may make the allocation process predictable. Therefore, to reduce selection bias and 
achieve balance across the intervention arms, a sequence list of individual assignments by 
random block sizes will be generated. 
Both groups will be assessed in a pre/post intervention design and will be compensated for 
completing study questionnaires. During the time that they are involved in the study, the 
intervention group will be sent (via Concussion Coach) reminders to engage with the App. Their 
use (e.g., total time spent on each component of the App) will be collected electronically. Both 

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groups will receive care as usual (meaning their regularly scheduled VA appointments and 
medications). At the completion of the study, both groups will be encouraged to download the 
App for their own use, with assistance from the study team if needed (see Figure 2). 
Description of Intervention & Training  
The Concussion Coach is designed to provide psychoeducation, self-assessment, and 
treatment of PCS following a mild TBI. The PI and three of the co-investigators were co-
developers of Concussion Coach. The public-facing Concussion Coach will be available for free 
download from a public marketplace and available for use with most mobile devices. The 
application has the advantage of privacy and anonymity, thus addressing the stigma often 
expressed as a barrier to seeking treatment. A mirror version of the public version, called 
Concussion Coach “Explorer Version”, was developed and is being used for this study. Unlike 
the public version, it has the capacity to collect usage information, such as length of time spent 
on each part of the app, self-report ratings of symptoms and distress, and identification of 
“favorites” among the self-help tools. This data can be uploaded in a de-identified form to a 
HIPAA compliant server. Other than the ability to collect data, it will be exactly like the “real” 
Concussion Coach. The Explorer version will be developed by our collaborators, Vertical 
Product Development, which developed Concussion Coach, PTSD Coach, and PTSD Explorer 
version. Explorer versions are especially useful as they allow for unobtrusive, highly detailed, 
real-time data collection without relying on patient self-report. In addition, the Concussion Coach 
will be an ‘opportunistic’ exporter of data. It will upload data to the server whenever it has new 
data and is in a Wi-Fi zone; participants do not have to have a home wireless network. If they 
never enter a Wi-Fi area, we will collect the data from their smart phone or iPod device at the 
second and final study visit. We will utilize ohmage, an existing open source technology stack, 
to port the app to the server. 
Concussion Coach has the following components in addition to a ‘Resources’ 
section: 
• 
Psychoeducational content covering basic information about mild TBI, associated 
symptoms, and resources for additional help. The information is derived from various VA 
and DoD informational websites and is based on the scientific literature on TBI. There are 
approximately 10 headings (e.g., “What is TBI?”) that can be clicked to receive educational 
information. Additionally, each answer includes an icon, visually represented by an ear that 
the user may tap in order to hear the information spoken aloud. 
• 
 Self-assessment using the Neurobehavioral Symptom Inventory (NSI), a validated measure 
of 22 PCS that is used broadly throughout VA, DoD, and civilian settings. Users are 
provided with interpretive feedback about the severity of their symptoms and information 
about their score relative to the last administration.  Repeated self-assessment can be 
viewed in graphical form. Users can also schedule future assessments and reminders to 
complete the NSI.  
• 
 Portable skills are available to address the Veteran’s symptoms, regardless of etiology. The 
user identifies and rates the distress from a list of symptoms. Depending on the problem and 
the severity, the user is routed to any of a number of helpful skills depending on the 
symptom and severity; the user is then asked to rate his/her distress following use of the 
stress management tool.  Feedback and recommendations are provided based on the 

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change in score. Irritability, sleep problems, memory problems, and headaches are the four 
foci of this app. If a symptom is rated 9 or 10, crisis strategies are provided. 
 
Training: Concussion Coach will be publicly available just as is the PTSD Coach.  To facilitate 
its use, the developers will create a brief handout to provide basic instructions on its use. Dr. 
Julia Hoffman, the primary author of both the PTSD Coach and the Concussion Coach, will be 
responsible for this content. Therefore, we are testing Concussion Coach as it will be 
implemented outside of this trial, increasing applicability of our findings to the “real world.”  
Safety Plan: If participants voice suicidal ideation/plan either in person or via telephone to study 
staff, hospital policy will be followed. There are specific policies in place for crisis management 
both via telephone and in person. All research personnel with participant contact will be trained 
per this policy.  In addition, interviewers and research assistants will be trained by the PI on how 
to identify and respond to participants in distress.  This will occur through role play, readings, 
and other pre-study group trainings. All proposed pertinent study personnel have clinical 
training/experience and suicide/violence assessment experience. They will follow VA Suicide 
Prevention guidelines and are required to have had all VA research trainings which include 
Suicide Prevention guidelines.  
Data Collection Methods: After informed consent and randomization, participants will 
complete baseline study measures. At follow-up, participants will be re-assessed using the 
same measures via mail, telephone or in person with telephone reminders, if needed. In 
addition, Concussion Coach will also collect the extent of their interaction with the 
application during their participation.  
Individual interviews will be conducted with at least 10% of the Concussion Coach users 
to evaluate their perception and satisfaction with other TBI-related education received within 
the VA to date, their overall satisfaction with Concussion Coach e.g. its ease of use, 
perceived barriers and facilitators to the use of the App, behavioral intention to use 
Concussion Coach in the future and recommendations for improving it. This 10% sample will not 
be random – rather we will solicit interviews from  those who improved using PCS  Concussion 
Coach, those who did not get better or became worse, and those who did not use the App 
during the study period or used it infrequently. In addition to qualitative questions about barriers 
and facilitators, interview questions will include quantitative assessment of satisfaction (e.g., 
rating scales of satisfaction). Interviews will be conducted by experienced trained interviewers 
(e.g., Delikat) and will be audio recorded. Participants will already be consented in person or 
over the telephone, so the interviewer will identify and briefly recap the consenting process, the 
project, and then ask permission for audio tape recording the interview. Interviews will be 
conducted by phone or in person based on participant convenience. The interviewer will use 
standard communication techniques to stimulate discussion such as generic prompts (tell me 
more), summarizing statements, silence, and eye contact. If the respondent exhibits adverse 
reactions, such as shame, during the interview, every effort will be made to encourage him or 
her and they will be reminded of their rights as participants. 

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Risk Minimization Plan: 
The educational program is self-administered and participation is strictly voluntary. There are no 
known risks involved. The PI will inform participants of all methods used to maintain 
confidentiality of information.  Participants will be assured of the confidentiality of the data and 
that no one outside of the research team will have access to the raw data.   
A lack of privacy may be a potential risk; therefore, participants will be assured of the 
confidentiality of the data and that no one outside of the research team will have access to the 
raw data.  The PI will inform participants of all methods used to maintain confidentiality of 
information. 
All data will be coded by number and stored in locked computer files. Only the investigators will 
have access to the data. Individuals will be informed that they may be contacted in the future for 
continuing involvement in this research study if funding is maintained. The smart phone 
application will be encrypted and the encryption will be FIPS 140-2 validated.   
De-identified data from the USF server will be sent to the PI via password protected email, using 
winzip software. 
Data collection instruments will be collected using Microsoft Access Database or on paper and 
pencil instruments and will be collected on scannable forms using Teleform technology. We 
have used Teleform for five years in a variety of projects and have found it to be accurate, 
reliable, and efficient. Scanning allows the data to be directly placed into a database for 
subsequent data cleaning and analysis using SAS. Data will be housed in Tampa. Care will be 
taken to ensure that sufficient backup procedures are in place. To assure intact data files, we 
will copy the raw data file into a data file for computation and analysis so that if there are 
computational errors or computer problems, the raw data will remain unchanged. This system 
has been used in several previous studies, and it ensures confidentiality and adheres to all 
HIPAA guidelines.  
Once data is either hand entered or scanned into databases, electronic data will be maintained 
on password protected VA servers in Tampa with two firewalls within a research building that is 
kept locked with an entrance manned by security personnel.  Physical paper data will be housed 
at 8900 Grand Oak Circle, Room 183 at the James A Haley Hospital in Tampa, and will be kept 
in a locked file cabinet in a research building that is kept locked with an entrance manned by 
security personnel. At Bay Pines VAHCS, physical paper data will be stored in locked cabinets 
in a locked office located within a locked building. 
Data from the Concussion Coach application will be electronically sent to the USF server. It will 
be de-identified (but matched to a study number that will identify the individual to the study 
coordinator who will need it for follow-up).  It will be periodically emailed to study personnel at 
the Tampa VA via password protected email, using winzip software. 
Finally, data from the recorded qualitative interviews will be transcribed by VA key personnel or 
by the Alpha Transcription Corporation and placed in the secure folder of the VA server as 

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described above. Alpha Transcription Corporation will be given access to a specific secure 
folder of the VA for the recorded qualitative interviews data to be transcribed. 
The risk associated with this study is minimal.  The only link between participant data and their 
identity is the study code (and the list matching the study code numbers to the individual will be 
securely held by the study coordinator). The research data will be kept on a secure VA shared 
drive.  A secure folder will be set up, allowing access to only key personnel that need access to 
the data.  Once a key personnel individual is no longer part of this study their name will be 
removed from the list of key personnel with access.  They will no longer be able to open the 
folder. The ISO and Privacy Officer will be notified within one hour of any improper use or 
disclosure, as well as any other violations of local policies. 
Providing education following a mild TBI is the most well researched and valid intervention for 
reducing overall post-concussion symptom severity. We postulate that mobile technology is 
likely to be an efficient delivery mode of this psycho-education and will enhance access for 
Veterans.  The potential benefit of learning about expected recovery, learning self-management 
techniques, learning how to get support and assistance, as well as the ability to do these things 
at one’s own pace and in one’s home environment far outweigh the minimal risks associated 
with participation. 
Safety Plan: If participants voice suicidal ideation/plan either in person or via telephone to study 
staff, hospital policy will be followed. There are specific policies in place for crisis management 
both via telephone and in person. All research personnel with participant contact will be trained 
according to this policy.  In addition, interviewers and research assistants will be trained by the 
PI on how to identify and respond to participants in distress.  This will occur through role play, 
readings, and other pre-study group trainings. All proposed pertinent study personnel have 
clinical training/experience and suicide/violence assessment experience. They will follow VA 
Suicide Prevention guidelines and are required to have had all VA research trainings which 
include Suicide Prevention guidelines.  
 
5.2 Recruitment Methods 
• 
State how many subjects will be needed.  
• 
Describe when, where, how and by whom potential subjects will be 
identified and recruited.  
• 
Describe materials that will be used to recruit subjects, e.g., 
advertisements.  Include materials as an appendix or separate 
attachment. 
• 
Describe any payments to subjects, including the amount, timing (at the 
end of the study or pro-rated for partial study participation), method (e.g., 
direct deposit or check), and whether subjects will experience a delay in 
receiving the payment. 
 

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Study Population: Approximately 600 patients with a history of mild TBI and current symptom 
complaints will be recruited.  Participants will be recruited from both the Tampa VA (lead site) 
and the Bay Pines VA, which is located about 20 miles from the Tampa VA within VISN 8, and 
their respective outpatient clinics (CBOCs). Both sites are Polytrauma Network Sites (PNS) 
which are designated sites within the VA Polytrauma System of Care that assess TBI 
outpatients and see the majority of mild TBI patients.   
To ensure that we capture a broad spectrum of Veterans with a history of mild TBI, we will also 
supplement recruitment from the VA with several methods aimed at recruiting potential 
community-based TBI participants. Primary recruitment will be through TBI-relevant clinics at 
both Bay Pines and Tampa VAs. Both facilities have active PNS clinics (Polytrauma Network 
Sites), Post-Deployment, PTSD and other clinics with patients identified to have a history of mild 
TBI. The recruiter and PI/Site PI and co-investigators will identify potential participants through 
their regular contact with patients. When a clinician determines that a patient is eligible (based 
on study inclusion/exclusion criteria), the clinician will either approach the patient to discuss 
his/her interest in research, or will refer the patient to a member of the research team.  The 
recruiter, or other co-investigators, will approach potential participants, inform them of the study, 
and verify their eligibility. If potential participants are interested, the recruiter will obtain written 
informed consent and HIPAA authorization.  
It is possible that potential participants will not be able to meet in person and will need to talk to 
a study investigator via telephone.  In this instance, a study investigator will explain the study 
determine that the participant is interested in participating, and screen for eligibility.  If eligible, 
an appointment will be scheduled for the participant to meet in-person with the study team 
members to complete the consenting process.  Or, for interested participants who reside a 
distance away from the VA and would like to participate in the study the ICF will be done over 
the telephone. After the Telephone Consent process is complete, a copy of the study 
ICF/Information Sheet will be mailed to the participant for his/her file. Once the consent process 
is completed via telephone with those participants who are not able to physically be at either the 
Tampa or Bay Pines VA site location, they will be asked to complete the study Baseline 
questionnaires. When speaking to potential participants via telephone, the study team member 
will be physically located at the Tampa or Bay Pines VA.  
To facilitate the recruitment process, we will hang flyers throughout the hospitals and catchment 
area (e.g., outpatient clinics) of each hospital, and provide the clinical team with hospital-based 
flyers and business cards to give to interested patients. (See the Appendix for the hospital-based 
flyer and business card.) 
Relevant Veteran Events: With permission from event organizer(s) and/or department 
manager(s), we will attend and/or contribute to relevant events around the Tampa/St. 
Petersburg area.  Methods of recruitment during events may include but are not limited to, 
providing flyers, cards, and/or give-away recruitment materials. It may also involve giving a short 
presentation on the participation opportunities, collecting contact information from interested 
participants, or leaving a basket of give-away recruitment materials at a desk for interested 
participants to pick up at their leisure (the flyers, business cards, and give-away recruitment 

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materials are attached as an Appendix). Events and departments could include but are not 
limited to the University of South Florida’s Veteran events and program, The Defense and 
Veterans Brain Injury Center events, Family Care events, Yellow Ribbon Reintegration Program 
Events, MacDill Air Force events, or Family/patient educational meetings. Interested participants 
will have the option to take recruitment materials away with them and make contact with a study 
team member at a later date themselves and/or leave their name, contact details, and preferred 
day/time with the study team member at the event who will contact them at a later date to 
initiate consent and enrollment. We will not be consenting participants at the Yellow Ribbon 
event.  
Publicizing though various forms of media: We will publicize the study through various forms 
of media. We will contact new organizations and include new forms of media as possibilities 
when they are brought to our attention or as recruitment needs change. We will not submit 
these new organizations for IRB review but will use approved methods. Future possibilities 
include but are not limited to the National Military Family Association, Stars and Stripes, or 
Military Base newspapers. Currently, we plan to publicize in Military Times, Veterans of Foreign 
Wars Magazine, and through social media of relevant organizations. A half page community 
based color advertisement (circulating between two Half Page Ads, see Appendix) will be 
placed in the Military Times Combined newspapers (militarytimes.com; militarytimesedge.com; 
Army Times, armytimes.com; Navy Times, navytimes.com, Air Force Times, airforcetimes.com; 
Marine Corps Times, marinecorpstimes.com). A fullpage advertisement (as per the community-
based flyers) will also be placed in the Veterans of Foreign Wars Magazine (official publication 
of the Veterans of Foreign Wars of the United States). Additionally, the social media mangers of 
the following organizations (Wounded Warrior Project, Army, Marines, National Guard, Air 
Force, Navy, Brain Line) will post a brief advertisement (including a link to a PDF version of the 
flyer) on their Social Media sites (e.g., Facebook, Twitter feeds, press release, attached in the 
Appendix). Please see the attached Agreements to Support Publicizing Efforts and weblinks to 
social media pages from the related social media managers (Appendix).  At Bay Pines VAHCS, 
efforts will also be made to contact Veterans who subscribe to Veterans Health via Email Blasts 
generated by the Public Affairs Officer. 
Finally, we will send letters to potential participants, identified through VA national databases 
(with appropriate permissions), who have been screened and evaluated for concussion within 
the Bay Pines or Tampa VA systems of care and who were identified through that process as 
having a history of concussion. 
Potential participants may respond to these various publicizing efforts via the study telephone 
contact details. For those recruited from the community, the study team member will explain the 
study over the telephone, determine that the participant is interested in participating, and screen 
for eligibility. If eligible, the participant will complete the consent process over the telephone or 
an appointment will be arranged for in-person consent at the VA. After the telephone consent a 
copy of the ICF/Information Sheet will be mailed to the participant for his/her file. When 
speaking to potential participants via telephone, the study team member will be physically 
located at Bay Pines or Tampa VA facilities. 

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Participants will be reimbursed for the time spent completing the questionnaires. Payment will 
be provided via a check sent to the Veteran’s home or through direct deposit. We will 
compensate participants $20 for the time they spend completing the first assessment and $10 
for the time they spend on the second assessment.  In addition, 10% of participants who 
complete an interview will be compensated for their time ($10).  
5.3 Informed Consent Procedures 
Informed consent will be obtained from all participants. Potential participants will be 
approached by study personnel (recruiter or other study team member).  This will either 
be done via mailed letter, in person or by phone.  It is also possible that a potential 
participant will see one of our flyers or other marketing and call the recruiter.  If recruited 
in person, the recruiter will ascertain eligibility and do informed consent in a private 
office. These particular participants will be identified by clinical study personnel or other 
approved means. 
It will be explained to participants that if they choose not to participate they will receive the 
services that they would ordinarily receive and that is there is no penalty for not participating 
and that the study is entirely voluntary and that they are free to withdraw from the study at any 
time.  All personnel involved in the informed consent process will be trained by the PI to ensure 
that the process is explained properly and that there is no undue coercion.  The voluntary nature 
of the study will be emphasized and potential participants will be able to take home the consent 
document to read at their leisure if they prefer. 
Primary recruitment will be through TBI-relevant clinics at both Bay Pines and Tampa VAs. Both 
facilities have active PNS clinics (Polytrauma Network Sites), Post-Deployment, PTSD and 
other clinics with patients identified to have a history of mild TBI. The recruiter and PI/Site PI 
and co-investigators will identify potential participants through their regular contact with patients. 
When a clinician determines that a patient is eligible (based on study inclusion/exclusion 
criteria), the clinician will either approach the patient to discuss his/her interest in research, or 
will refer the patient to a member of the research team.  The recruiter, or other co-investigators, 
will approach potential participants, inform them of the study, and verify their eligibility. If 
potential participants are interested, the recruiter will obtain informed consent and HIPAA 
authorization. Or, if interested participants reside a distance away from the VA and would like to 
participate in the study the informed consent process will be done over the telephone. 
It is possible that potential participants will not be able to meet in person and will need to talk to a 
study investigator via telephone.  In this instance, a study team member will explain the study, 
determine that the participant is interested in participating, and screen for eligibility.  If eligible, an 
appointment will be scheduled for the participant to meet in-person with the study team member to 
complete the consenting process. Or, if interested participants reside a distance away from the VA 
and would like to participate in the study the consenting process will be done over the telephone. 
ICF/Information Sheet will be mailed to participants consenting over the telephone. When speaking 
to potential participants via telephone, the study team member will be physically located at the 
Tampa or Bay Pines VA. 

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Project Team 
Member   
Degrees 
Project Role  
Obtaining 
Informed 
Consent?  
Yes/No 
 
 
 
 
Gail Powell-
Cope 
PhD 
Co-I 
Yes 
Tracy Kretzmer 
PhD 
PI 
Yes 
Peter Toyinbo 
PhD 
Statistician 
No 
Heather 
Belanger 
PhD 
Consultant 
No 
Sharon Haire 
MA 
Co-I 
Yes 
Sarah Bradley  
Provisional 
CHP 
Qualitative Data 
Manager 
Yes 
Emily King 
PhD 
LSI 
Yes 
Zoe Proctor-
Weber 
PhD 
Co-I 
Yes 
Tanya Harris 
MD 
Co-I 
Yes 
Susan Horrigan 
MA 
Study 
Coordinator/Recruitment 
Yes 
 
 
 
 
Barbara 
McKenzie 
MA 
Project Manager 
Yes 
Blake Barrett 
MSPH 
Data Manager 
Yes 
Padmaja 
Ramaiah  
MSBME 
Research Assistant 
Yes 
Angel Klanchar 
MS 
Recruitment 
Yes 
Lee Augello 
 
Transcriptionist 
No 
Kevin Kip 
PhD 
Consultant 
No 
Tamara 
McKenzie-
Hartman 
PhD 
Research Associate 
Yes 

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Nina Sayers 
PhD 
Offsite Consultant/Co-I 
No 
 Jemy Delikat 
 MOT OTR/L 
Interviewer 
No 
 
Study personnel, including all personnel collecting informed consent, will be trained by the study 
team members.  The PI will lead a training session attended by all personnel involved in the 
informed consent process. All staff will have up-to-date required training. 
5.4 Inclusion/Exclusion Criteria 
Inclusion/Exclusion Criteria: To be eligible for the study, participants will be 18 or older with a 
history of mild TBI (DoD/VA criteria66 as determined by trained, experienced staff via interview 
and medical record review via comprehensive evaluation process within PNS Clinic65) with 
current symptoms complaints (operationally defined as at least two symptoms on the NSI 
endorsed at the ‘moderate’ level or a total score on the NSI greater than 25. At least 93.5 
percent of a sample of over 50,000 individuals with mild TBI within VA reported at least two NSI 
symptoms at a moderate level of severity or higher.67 In addition, eligible participants must 
speak and read English, not have a history of moderate to severe TBI, not have a self-reported 
diagnosis of psychosis or be actively suicidal. Finally, potential subjects who report prior 
experience with Concussion Coach will also be excluded. We will attempt to recruit women and 
minorities to the extent possible. Our experience suggests that approximately 4% female and 
30% ethnic minority will likely participate; they agree to participate in research at about the 
same rate as male and non-minority participants. Subjects who meet the inclusion/exclusion 
criteria and who agree to participate in the research study will sign an informed consent. 
5.5 Study Evaluations 
Table 1 outlines quantitative measures we propose to use. Examination of potential mediator 
and moderator variables will allow us to determine who is most likely to benefit from the 
intervention (e.g., people with limited social support, people who are less ‘tech savvy’) and 
qualify our findings. Justification for each of these included variables is contained in the 
description of each measure below the table. 
Table 1. Study Measures 
Construct 
Tool 
Timepoint 
Primary Outcomes 
 
 
PCS  
Neurobehavioral Symptom Inventory 
(NSI) 
Baseline, up to 1 
year later 
Symptom Exaggeration 
mBias 
Baseline, up to 1 
year later 
Psychological Distress 
Brief Symptom Inventory (BSI) 
PCL-5 Strong Star (PCL) 
Baseline, up to 1 
year later 

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Time Spent on 
Concussion Coach in 
total and on various 
components 
Concussion Coach download 
Duration of study 
i.e. a 3 month 
period for use of 
APP 
PCS  
NSI from Concussion Coach download 
(could be multiple NSIs depending on 
subject) 
Duration of study 
i.e. a 3 month 
period for use of 
APP 
Barriers and Facilitators 
of Concussion Coach 
use and effectiveness 
Concussion Coach Interview 
Follow-Up Data Form 
Up to 1 year later 
for Follow-Up 
Form. Interview 
date is an 
undetermined time 
after the final study 
visit. 
Potential Mediators 
 
 
Perceptions and 
Knowledge of Illness 
TBI Education Satisfaction, 
Knowledge, and Attributions 
Baseline, up to 1 
year later 
Self-Efficacy 
Self Efficacy for Symptom 
Management Scale (SEsx) 
Baseline, up to 1 
year later 
Potential Moderators 
                                           
 
Social Support 
Social Support Questionnaire – Short 
Form (SSQSR) 
Baseline, up to 1 
year later 
Comfort with Technology 
eHealth Literacy Scale (eHEALS) 
Baseline, up to 1 
year later 
Use of Apps during study 
period 
Follow-Up Data Form 
Up to 1 year after 
Baseline 
Mental Health Treatment 
during study period 
Follow-Up Data Form 
Up to 1 year after 
Baseline 
Demographics, Health 
and Disability Status 
 
 
Age, gender, diagnosis, 
comorbidities, other 
injuries. 
 
Medical Record:  
Baseline 
Participant Information Form 
Enrollment Participant Information 
Form 

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Primary Outcome Measures: 
• 
Neurobehavioral Symptom Inventory (NSI) is a 22-item questionnaire developed to evaluate 
post-concussion symptoms following mild TBI.52  It is used throughout the VA system of care 
to assess complaints associated with identified concussion. Patients are asked to rate each 
symptom on a scale of 0-4 (none, mild, moderate, severe, and very severe) with three 
different types of symptoms: affective/psychological/stress, somatic/physical, and cognitive 
reflecting three factors.  The total score will be used in primary analyses. It is our primary 
outcome of interest because the civilian literature on interventions for mild TBI has focused 
(and found effects) on symptom-based measures.41 53  Our own pilot data suggests that 
educational interventions have a significant impact on this measure. 
• 
mBIAS is a 5-item measure of atypical symptoms.  It is associated with symptom 
exaggeration following mild TBI (Cooper et al., 2011). 
• 
Brief Symptom Inventory 18 (BSI 18) is a self-report measure with 18 items designed to 
measure psychological distress. It can be completed in approximately 4 minutes and is well-
suited for helping measure symptom change due to treatment.  It has good psychometric 
properties and has been used in the population of interest. It measures three primary 
dimensions: Somatization, Depression, and Anxiety, as well as a Global Severity Index 
(GSI).  The GSI will be used in primary analyses as a measure of overall psychological 
distress. The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20-item, self-rating scale 
that provides a quick and accurate measure of PTSD symptoms. Each item corresponds to 
current diagnostic criteria of PTSD, and each symptom is rated in terms of frequency and 
severity (Weathers, Huska, & Keane, 1991).Participant use of Concussion Coach will be 
collected electronically, including total time spent using the app as well as each component.  
• 
Concussion Coach Interview (Tampa VA, unpublished). We have developed an interview 
that combines open-ended questions about use of the Concussion Coach with rating scales 
to assess satisfaction with the TBI app.  Interviews will be conducted with a purposive 
sample of 10% of Concussion Coach users at study end to evaluate their satisfaction with 
Concussion Coach, ease of use, barriers and facilitators to use of Concussion Coach, 
behavioral intention to use Concussion Coach in the future and recommendations for 
improving it. We will use purposive sampling for participation in these interviews. We will 
solicit interviews from 10% of those who improved on PCS using Concussion Coach and 
10% who did not improve or became worse. In addition to qualitative questions about 
barriers and facilitators, interview questions will include quantitative assessment of 
satisfaction (e.g., rating scales of satisfaction). Interviews will be conducted by experienced 
trained interviewers (e.g.,Delikat) and will be audio recorded. Participants will already be 
consented, so the interviewer will identify and briefly recap the project, and then ask 
permission for audio tape recording. Interviews will be conducted by phone or in person 
based on participant convenience. The interviewer will use standard communication 
techniques to stimulate discussion such as generic prompts (e.g. tell me more), 
summarizing statements, silence, and eye contact, if conducted in person. If the respondent 
exhibits adverse reactions, such as shame, during the course of the interview, every effort 
will be made to encourage him or her and they will be reminded of their rights as 
participants. 
• 
Follow-Up Data Form 
      Potential Mediators: 
• 
TBI Education Satisfaction, Knowledge, and Attributions Questionnaire is a 24 item modified 
version of the Brief Illness Perceptions Scale,54 which assesses TBI education,  knowledge, 
and attributions related to PCS. This measure is included due to the well known impact that 

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symptom attributions can have on outcomes following mild TBI 55-57 and to explore the 
relationship between outcomes and prior exposure and satisfaction with the VA’s existing 
TBI education. 
• 
Self Efficacy for Symptom Management Scale (SEsx) is a measure of confidence or 
perceived self-efficacy for managing chronic conditions. Perceived self-efficacy has been 
shown to influence a broad range of health-related and rehabilitation outcomes and may be 
particularly relevant in examining the effects of neuropsychological rehabilitation. Previous 
research has demonstrated an empirical relationship between generalized self-efficacy and 
outcomes after TBI.58 
Potential Moderators: 
• 
Social Support Questionnaire – Short Form (SSQSR) 59 60 is a 12-item questionnaire that 
measures both availability and satisfaction with social support.  Social support is known to 
be associated with outcomes from TBI.61 62 
• 
An adapted eHEALS, 10-item measure of eHealth literacy was developed to measure 
consumers' knowledge, comfort, and perceived skills at finding, evaluating, and applying 
electronic health information to health problems. Based on responses of 664 participants 
aged 13 to 21 internal consistency reliability was found to be .88. Test-retest reliability from 
baseline to 6-month follow-up (r = .68 to .40). Principal components analysis produced a 
single factor solution (56% of variance).63 
Demographics, Health and Disability Status:   
• 
The Participant Information Form gathers pertinent demographic data. 
• 
Enrollment Participant Information Form 
 
Individual interviews (see Appendix for script) will be conducted with 10% of the Concussion 
Coach users at study end to evaluate their satisfaction with Concussion Coach, ease of use, 
their perception and satisfaction with other TBI-related education they have received within the 
VA to date, barriers and facilitators to use of Concussion Coach, and behavioral intention to use 
Concussion Coach in the future. This 10% sample will not be random – rather, we will solicit 
interviews from  those who improved on PCS using Concussion Coach, those who did not get 
better or became worse, and those who did not use the App during the study period or used it 
infrequently. In addition to qualitative questions about barriers and facilitators, interview 
questions will include quantitative assessment of satisfaction (e.g., rating scales of satisfaction). 
Interviews will be conducted by experienced trained interviewers (i.e.,Delikat) and will be audio 
recorded. Participants will already be consented in person or over the telephone, so the 
interviewer will identify and briefly recap the project, and then again ask permission for audio 
tape recording. Interviews will be conducted by phone or in person based on participant 
convenience. The interviewer will use standard communication techniques to stimulate 
discussion such as generic prompts (e.g., tell me more), summarizing statements, silence, and 
eye contact, if conducted in person. If the respondent exhibits adverse reactions, such as 
shame, during the interview, every effort will be made to encourage him or her and they will be 
reminded of their rights as participants. 
5.6 Data Analysis 

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810 potential 
participants – 33 
months 
60% agree to 
participate 
(N = 486) 
Assigned to TBI Coach  
(N = 243) 
Assigned to Control Group 
(N = 243) 
20% Attrition 
Outcome Measures N = 388 
(25 TBI Coach Interviews) 
Figure 2.  Expected Total Recruitment 
Sample Size Justification: Below is a diagram of the expected subject recruitment and attrition 
(see Figure 2).  Our recruitment estimates are based on our experience with prior trials (e.g., a 
recent pilot study of a web based intervention successfully recruited over 90% of potential 
participants) and our emphasis in the budget of recruitment personnel who will be embedded in 
our clinics. We conservatively estimate that 60% of potential participants will agree to participate 
and be successfully enrolled in the study.  Our attrition estimate of 20% is based on our 
experience with an internet self-help intervention study, during which drop out was less than 
20%.  This was accomplished through continued outreach by the recruiter via letter and calls. 
Based on these conservative numbers and a recruiting period of 33 months we expect a 
minimum N=388 participants in the study [(20 newly identified participants per month over 33 
months + 150 existing) *60% participation* (1-20% attrition)]. This is a conservative estimate 
because we have excluded the existing 
1,332 potential participants living in our 
area (national dataset) to whom we will 
mail letters. 
For each regression model proposed for 
H1&2, results of sample size calculation 
using the application PASS v11 (Hintze, 
2011) show that a much smaller N=148 
(or N=194) achieves 80% (or 90%) 
power to detect an additional R-Squared 
of 0.05 (proportion of explained variation 
in the outcome) attributed to 2 
independent variables (TBI Coach plus 
an interaction) using an F-Test with 
alpha of 0.05. This assumed the 
variables tested are adjusted for 10 
independent variables with an R-
Squared of 0.20. 
We note that of all statistical models 
proposed in this study, the mediation 
model has the most stringent sample 
size requirement. With conservative total 
N=388, we expect to have greater than 
.80 power to detect a small to medium 
effect size of the mediated effect at 
alpha = 0.05. The two regression 
coefficients (beta1 & beta2) that jointly 
capture the mediated effects are critical 
in the power calculation for a mediation 
model. Using the parameter values of 0.14, 0.39, and 0.59, corresponding to Cohen’s criteria68 
for small (2% of the variance), medium (13% of the variance), and large (26% of the variance) 
effect sizes, respectively, Fritz and MacKinnon (2007) conducted empirical estimates of sample 

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sizes needed for .8 power at 95% confidence level. Their results showed that when bias-
corrected bootstrap is used, N=462 is adequate to detect small effect size for each of alpha and 
beta while N=377 is adequate to detect small/medium effect size combination for both alpha 
and beta.69 Conservatively we expect to recruit N=388. We calculated directly the power for 
testing mediation effect based on Sobel's test (Sobel, 1982) using the R package ‘power 
Mediation’. By specifying Cohen's small ES for each coefficient in the indirect pathway (beta1 = 
beta2 = 0.14) and with the following assumptions: both the predictor and the mediator have S.D. 
of 0.5 while the square of the correlation between both equal 0.3; and S.D. of the random error 
term is 0.2; the expected N=388 will provide 0.82 power to detect the small mediation effect 
size. 
Sample Size for Qualitative Research Questions: In qualitative research, sample size relies 
on the quality and richness of information obtained.70 71 Achieving conceptual saturation is the 
goal of qualitative research and is not dependent on sample size but on the ability of the data to 
support interpretations, i.e. saturation.70 71 For this aim, we project saturation will occur within 
the first twelve interviews; meta-themes will present in six interviews.72 Thus we will recruit 10% 
of Veterans to provide adequate data to represent sub-groups that may emerge from the 
sample and allow for an adequate sub-sample sizes; allowing for some attrition. For example, 
we expect low volume and high volume users; those who intend to have continued use and 
those who may not. This will also allow sampling groups for analysis by socio-demographics 
such as gender and race.  We have budgeted to recruit 10% of Veteran participants to conduct 
the proposed interviews. 
Data Analysis: 
Data from the Concussion Coach application will be electronically sent to the USF server. It will 
be de-identified (but matched to a study number that will identify the individual to the study 
coordinator who will need it for follow-up).  It will be periodically emailed to study personnel at 
the Tampa VA. 
Data from paper questionnaires will be obtained from the recruiter and study personnel and 
maintained by the study coordinator.  Again, study numbers will be used to identify participants.  
All data will be combined into a study database.  The integrity of the database will be managed 
by our database manager.  Analyses will be conducted by the statistician (Peter Toyinbo) and 
the PI (Tracy Kretzmer). 
Data Analysis Plan: An intention-to-treat (ITT) analysis will be performed, that is analysis will 
be based on the groups to which participants are randomized regardless of whether they 
receive or adhere to the assigned intervention. This will allow us to test the effects of assigning 
TBI Coach in practice, separate from assessing effects of adherence and/or loss to follow-up. 
Those who are lost to follow-up and therefore are missing outcome measures (T2 assessments) 
will be included in separate comparison analyses that utilize multiple imputations of the missing 
data. 

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For each primary outcome and other measures consisting of multiple items, a summation score 
will be produced for each subject. Summary of each variable by intervention group will be cross-
tabulated. The time spent on TBI Coach and its specific components on the average will also be 
tabulated. All primary outcomes will be analyzed as continuous variables. Exploratory bivariate 
plots will be used to investigate possible nonlinear relationships between baseline/covariates 
and each follow up outcome variable. In separate statistical models proposed, we will control for 
demographics and other covariates including the baseline values of the outcome under 
investigation. Where appropriate, nonlinear regression model will be utilized (e.g., generalized 
additive model).  
Hypothesis 1 (Primary Hypothesis): Patients randomized to receive TBI Coach for 3 months 
will have (a) lower post-concussive symptom severity and (b) lower psychological distress, 
compared to patients randomized to a no intervention control group, after adjusting for baseline 
severity and other potential confounders. 
Analysis: The two intervention groups (TBI Coach = 1; Control = 0) will be compared on each 
outcome (a) and (b) in separate regression models that include the group variable and control 
for the outcome at baseline and other potential confounders. A significant positive estimated 
coefficient of the group variable will indicate positive TBI Coach’s effects on the outcome, with 
the standardized value of the coefficient as the standardized effect size. 
 
Hypothesis 2: The effects of TBI Coach on PCS (and psychological distress) will be greater for 
Veterans who have (a) greater comfort with technology at baseline than for those who are less 
comfortable; (b) greater social support at baseline than for those with less social support. 
Analysis: Two separate tests of moderated effects of TBI Coach will be performed with respect 
to each outcome. Each regression model in H1 (one per outcome) will be extended by adding a 
2-way interaction term (between intervention and (a) eHealth Literacy Scale and (b) Social 
Support score; one at a time (i.e. two different moderation models per outcome). A significant 
coefficient of an interaction term will indicate presence of interactive effects. A co-plot using 
model fitted values will also be produced to further investigate the nature of any significant 
interaction. 
Hypothesis 3: If TBI Coach improves Veterans’ (a) knowledge about TBI and attribution of 
symptoms and/or (b) self-efficacy in coping with symptoms, Veterans will have less PCS and 
Psychological Distress. 
Analysis: Single-mediator models73 will test the indirect effects of the group variable (TBI Coach) 
on each outcome (separately) with respect to mediating variables: (a) knowledge and 
attribution, and (b) self-efficacy. Preliminary regression analyses will test whether (1) TBI Coach 
substantially changes the mediating variable, and (2) the mediating variable changes the 
outcome. Next, we will proceed to a full mediation model with simultaneous estimation of both 
direct and indirect effects of TBI Coach on the outcome. The mediated effect will be estimated 
as a product of the two path coefficients alpha and beta in the indirect pathway. The distribution 
of the product of coefficients is non-normal and this has implications for statistical inference as 
well as power calculation (see section on sample size justification). Therefore, the analysis will 

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be performed using the Mplus statistical application which offers alternatives that do not require 
the regular assumption of symmetric, normal distributions for parameter estimates. Bayesian 
estimation method with diffuse priors will be used with appropriate posterior simulation schemes 
based in Markov Chain Monte Carlo (MCMC) methods. One advantage of the MCMC estimation 
process is that it provides accurate tests of mediated effects for small samples; e.g. by simply 
taking the product of the two coefficients alpha and beta for every draw and compute its 
standard deviation across all draws to obtain standard errors of mediated effect. Also, unlike the 
normal-based ML confidence interval, inference will rely on Bayesian credibility interval based 
on the percentiles of the posterior, which easily allows for a strongly skewed distribution alpha-
beta product74  
Hypothesis 4:  More time spent on (a) TBI Coach use, and (b) specific interactive components 
of TBI Coach (i.e., the “tools” section) will be associated with lower PCS symptom severity after 
adjusting for baseline PCS values and potential confounders. 
Analysis: A regression model of PCS will be performed on the TBI Coach sample only, 
separately for (a) TBI coach use, and (b) each interactive component as the main predictor. 
First the PCS baseline score, demographics and other potential confounders will be included in 
the base model. Then a full model with addition of the time score for one TBI Coach aspect at a 
time will be fitted. Appropriate transformation (e.g. log) of all time variables will be done as 
suggested by their general distribution; a significant negative coefficient of the time variable will 
confirm a negative association between time spent on that component and symptom severity. 
Standardized coefficient estimates as well as R-sq estimates will be obtained so that all TBI 
Coach aspect-specific models can be compared on the relative strengths of the aspect-outcome 
relationships.  
As an extension, secondary analysis will be performed on the TBI Coach components that show 
strong relationship in the expected direction. Each time spent (as a dependent variable) will be 
regressed on the predictors in the base model to identify both positive and negative contributory 
factors to the specific component usage.  
5.7 Withdrawal of Subjects 
We do not and cannot anticipate any circumstance under which subjects will be withdrawn from 
the research without their consent. There will be no consequences if a subject decides to 
withdraw from the study. Indeed, the voluntary nature of the study will be stressed during the 
informed consent process.  Contact information for study personnel will be given to each 
participant.  
6.0 
Reporting 
We do not anticipate any serious events. If the respondent exhibits adverse reactions, such as 
shame, during the interview portion of the study, every effort will be made to encourage him or 
her and they will be reminded of their rights as participants.  A highly trained and experienced 
interviewer will conduct the interviews. 
If participants voice suicidal ideation/plan this will be reported as a SAE or UAP.          

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We will inform the Central IRB of any unanticipated problems through information reporting and 
continuing reviews. 
7.0 
Privacy and Confidentiality 
We are requesting a HIPAA waiver for identification of potential participants.  Without identifying 
potential participants (with a medical history of concussion), we would need to screen all 
patients within our two sites somehow, and make them go through a redundant evaluation to 
determine that they’ve had a concussion.  This would be incredibly inefficient, since we are only 
targeting people who have had a concussion.  The VA has a screening and evaluation process 
in place that can help us hone in on participants who might benefit and are eligible for this study. 
Identifying subjects that meet inclusionary criteria and garnering contact information requires 
access to the protected health information. Without this information, there is no practical means 
of contact within the context of this study.  Gaining consent from the entire VA patient population 
is impractical. 
In addition to diagnosis, we will need name and mailing address since we would like to send 
letters, asking potentially eligible participants (those with history of concussion) if they would be 
interested in participating.  We will get this information from CPRS data from both Tampa and 
Bay Pines VA. We will also request national data on the TBI evaluation results from the 
appropriate sources (VHA Support Service Center (VSSC), national PM&R office national data 
system). 
After participants are identified, no longer will any PHI be tied to an individual participant. In 
other words, data will be linked to a specific subject by a code rather than a direct identifier.  
There will be no identifying information on the questionnaire data, the interview data, or in the 
electronic data that is transmitted from the smart phone application to the server. 
Patient data will be kept on networked, password protected VA computers and on VA servers in 
files with access limited to study personnel.  Hard copies of the Informed Consent Forms and 
other data collection instruments are kept in locked file cabinets in an office that is kept locked 
when unoccupied.  HIPAA privacy rules will be strictly maintained. Data will not be shared with 
anyone other than who is named in the consent form. All paper records will be maintained in 
locked files within a locked office. All electronic study data will be stored on a password 
protected database with access limited to select research personnel and will be encrypted and 
protected by firewall per VA guidelines. The PI and all study personnel will be responsible for 
ensuring that the research is conducted in a manner consistent with the ethical principles 
outlined in the Belmont Report, and in compliance with USF policies and procedures. A similar 
smart phone application has already been developed by the VA.  It will be encrypted and the 
encryption will be FIPS 140-2 validated.   
8.0 
Communication Plan 

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All local site approvals will be obtained and maintained by the Lead Site (Tampa)’s study 
coordinator. If there are any problems, this will be communicated to the PI who will work 
to resolve it with the site PI at Bay Pines. 
The lead study coordinator at Tampa will be responsible for keeping the Bay Pines study 
staff informed of any changes to study procedures, any changes required in 
documentation, any serious adverse events or unanticipated problems.  The PI will 
inform Bay Pines study staff of any interim results that may impact the conduct of the 
study. 
Regular, scheduled communication will occur between Tampa and Bay Pines via email 
and telephone. In person meetings will occur as necessary. As the PI has worked with 
the site PI and co-investigator at Bay Pines in the past, we do not anticipate any 
problems with communication. 
The study will be largely implemented at Bay Pines by the site coordinator at Bay Pines 
(Horrigan), with oversight from the site PI. 
All personnel involved in the study will be trained by the PI to ensure that the study is 
faithfully carried out and implemented. Regular communication will also facilitate this. 
When the study is over, the PI and primary study coordinator will ensure that the Bay 
Pines site is aware.  

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