Smart Phone Application for Postconcussion Symptom Reduction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2014 |
| End Date: | December 2018 |
Smart Phone Application for Postconcussion Symptoms Reduction
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, "TBI Coach," one of a suite of mobile applications
developed by VA. The primary goal of the proposed study is to evaluate the efficacy of TBI
Coach for improving clinical outcomes in those with a history of mild TBI and to determine
what aspects of TBI 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.
Objectives. The study will pursue the following objectives:
1. Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of
TBI Coach.
2. Determine the aspects of TBI Coach most associated with positive outcomes.
3. Obtain qualitative information on factors associated with use of TBI coach or with
deriving benefit from use of TBI Coach that can be used to inform future modifications
of the application and wide scale implementation.
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, "TBI Coach," one of a suite of mobile applications
developed by VA. The primary goal of the proposed study is to evaluate the efficacy of TBI
Coach for improving clinical outcomes in those with a history of mild TBI and to determine
what aspects of TBI 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.
Objectives. The study will pursue the following objectives:
1. Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of
TBI Coach.
2. Determine the aspects of TBI Coach most associated with positive outcomes.
3. Obtain qualitative information on factors associated with use of TBI coach or with
deriving benefit from use of TBI Coach that can be used to inform future modifications
of the application and wide scale implementation.
Patients who meet eligibility criteria and consent to participate in the study will be
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. Study personnel will explain the purpose of the study, complete the informed
consent process, obtain the random treatment assignment from a randomization sheet, and
introduce the participant to his/her baseline evaluator. 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 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
their time completing study surveys. During the 3 months that they are involved in the
study, the intervention group will be sent (via Concussion Coach) reminders to engage with
the app on a weekly basis. Their use (e.g., total time spent on each component of the app)
will be collected electronically. Both 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.
Description of Intervention & Training The Concussion Coach is designed to provide
psychoeducation, self-assessment, and treatment of PCS symptoms 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", will be
developed within three months and used for this study. Unlike the public version, it will
have 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. These 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 WiFi zone; participants do not have to have a
home wireless network. If they never enter a WiFi area, the investigators will collect their
data at study termination when the investigators collect the iPod touch®. The investigators
will utilize ohmage, an existing open source technology stack, to port the app to the
server.
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. Study personnel will explain the purpose of the study, complete the informed
consent process, obtain the random treatment assignment from a randomization sheet, and
introduce the participant to his/her baseline evaluator. 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 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
their time completing study surveys. During the 3 months that they are involved in the
study, the intervention group will be sent (via Concussion Coach) reminders to engage with
the app on a weekly basis. Their use (e.g., total time spent on each component of the app)
will be collected electronically. Both 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.
Description of Intervention & Training The Concussion Coach is designed to provide
psychoeducation, self-assessment, and treatment of PCS symptoms 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", will be
developed within three months and used for this study. Unlike the public version, it will
have 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. These 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 WiFi zone; participants do not have to have a
home wireless network. If they never enter a WiFi area, the investigators will collect their
data at study termination when the investigators collect the iPod touch®. The investigators
will utilize ohmage, an existing open source technology stack, to port the app to the
server.
Inclusion Criteria:
1. 18 or older
2. 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
3. Must speak and read English
4. Not have a history of moderate to severe TBI
5. Not have a self-reported diagnosis of psychosis or be actively suicidal.
Exclusion Criteria:
1. Subjects who report prior experience with Concussion Coach will also be excluded.
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