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IIR 13-196 – HSR&D Study

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IIR 13-196
Smart Phone Application for Postconcussion Symptom Reduction
Tracy S Kretzmer PhD BA
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, FL
Funding Period: October 2014 - December 2018

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:
We are still recruiting for this study:

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 (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.

IMPACT:
As mentioned preciously our finding we anticipate will lead to the improvement of Veterans' understanding perceptions of the use of mobile technology in VA and in healthcare settings more broadly. We will also learn their perceptions about the Concussion Coach application in particular, as well as its impact on learning and outcomes.

PUBLICATIONS:
None at this time.


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