BACKGROUND/RATIONALE:
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 (mild TBI) 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 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 TBI 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 mild TBI who still have symptoms months to years after injury.

OBJECTIVE(S):
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 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.

METHODS:
For this study, 486 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.

This is a randomized control trial.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 an iPod touch with the Concussion Coach "Explorer" version, or into the no mobile app control group.
Both groups are assessed in a pre/post intervention design and compensated for their time completing study surveys. 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 on a weekly basis. At the completion of the study, both groups are encouraged to download the App for their own use, with assistance from the study team if needed.
In addition, individual in-person interviews 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

FINDINGS/RESULTS:
The study enrollment is complete.

A total of 479 patients (95% of our goal) with a history of mild TBI and current symptom complaints were recruited and enrolled (238 in the treatment group and 241 in the control group). Participants were recruited from both the Tampa VA (lead site) and the Bay Pines VA, and their respective outpatient clinics (CBOCs). The average age of our participants was 41.5; 90.7% were male; and most (90.1%) sustained their mild TBI over one year ago.
Of the 479 patients enrolled, 405 completed the follow-up evaluation (84.6% of total sample). In addition, 35 participants completed the Qualitative interview.

a.Bayesian Network modeling was used to represent the probabilistic relationships between treatment group, covariates, and symptoms in an analysis that included 370 completers: Concussion Coach (n=175) and Treatment as Usual (n=195). Results of analyses indicate that Concussion Coach is effective at reducing post-concussion symptom (PCS) severity, though interactions with self-efficacy may be key to that relationship.
b.Results from this study support the ability of Concussion Coach to reduce PCS severity, but also highlight the importance of Veteran self-efficacy for these reductions in PCS. Smartphone interventions such as CC may be useful to improve Veteran well-being and reduce costs to the VA health care system through improved self-management of PCS symptoms.
c.Findings from this study suggest that smartphone applications can be effective means for post concussive symptom self-management, with potential clinical applications to other areas of medical need to improve Veteran health and health care system services use.

IMPACT:
a.Bayesian Network modeling was used to represent the probabilistic relationships between treatment group, covariates, and symptoms in an analysis that included 370 completers: Concussion Coach (n=175) and Treatment as Usual (n=195). Results of analyses indicate that Concussion Coach is effective at reducing post-concussion symptom (PCS) severity, though interactions with self-efficacy may be key to that relationship.
b.Results from this study support the ability of Concussion Coach to reduce PCS severity, but also highlight the importance of Veteran self-efficacy for these reductions in PCS. Smartphone interventions such as CC may be useful to improve Veteran well-being and reduce costs to the VA health care system through improved self-management of PCS symptoms.
c.Findings from this study suggest that smartphone applications can be effective means for symptom self-management, with potential clinical applications to other areas of medical need to improve Veteran health and health care system services use.
d. NATIONAL PRESENTATIONS:
1) Belanger, H., King, E., Toyinbo, P., McKenzie, B., Barrett, B., Ramaiah, P., Klanchar, A., Kretzmer, T., Vanderploeg, R., Proctor-Weber, Z., Powell-Cope, G., Kip, K., Hoffman, J., & Sayer, N. (August 2018). Technology-based interventions for concussion. Presentation at the American Psychological Association annual convention, San Francisco, CA. Symposium organized by Heather Belanger on "Concussions on Our Minds: Rehabilitation in Clinical Settings with Children, Athletes, Veterans."

2) Belanger, H. King, E., Barrett, B., Horrigan, S., Klanchar, A., McKenzie, B., & Ramaiah, P. (May 2017). Smart phone application for post-concussion symptom reduction. Poster presented at the 19th annual James A. Haley VA Hospital Research Day, Tampa, FL.

e. 2 articles under preparation:
1) Concussion Coach for post-concussive symptoms: A randomized, controlled trial. Manuscript to be submitted to The Clinical Neuropsychologist.
2) A Qualitative Assessment of the Use of a Smart Phone Application to Manage Post-concussion Symptoms in Veterans with Traumatic Brain Injury. Under review at JHTR

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External Links for this Project

NIH Reporter

Grant Number: I01HX001251-01
Link: https://reporter.nih.gov/project-details/8593385

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PUBLICATIONS:

Journal Articles

1. Bradley SE, Haun J, Powell-Cope G, Haire S, Belanger HG. Qualitative assessment of the use of a smart phone application to manage post-concussion symptoms in Veterans with traumatic brain injury. Brain injury. 2020 Jul 2; 34(8):1031-1038. [view]

DRA: Brain and Spinal Cord Injuries and Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Anxiety Disorders, Outcomes - Patient, Risk Factors, Social Support, Stress, TBI, Telemedicine/Telehealth
MeSH Terms: none