N/A
N=479
Smart Phone Application for Postconcussion Symptom Reduction
Concussion
Bottom Line
View on ClinicalTrials.gov: NCT02501642 ↗Enrolled (actual)
479
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Neurobehavioral Symptom Inventory — 33; 33 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Concussion Coach (Behavioral); Treatment as usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurobehavioral Symptom Inventory |
33; 33 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 18 or older
- History of mild TBI (DoD/VA) as determined by trained, experienced staff via interview and medical record review via comprehensive evaluation process within PNS 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
- 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
Exclusion Criteria
- Subjects who report prior experience with Concussion Coach will also be excluded
Data sourced from ClinicalTrials.gov (NCT02501642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.