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Smart Phone Application for Postconcussion Symptom Reduction
NCT02501642 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Treatment as usual
- BEHAVIORAL Concussion Coach
Study Locations (2)
Florida
- Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2014-12-01 |
| Est. Completion | 2018-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02501642
The ClinicalTrials.gov registry entry for NCT02501642 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 479 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Concussion appearing as the primary indexed condition, and to 2 interventions — of which Treatment as usual is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02501642 reports 2 study locations spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02501642 about?
NCT02501642 is a clinical study titled "Smart Phone Application for Postconcussion Symptom 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 hav...
What is the current status of trial NCT02501642?
This trial is currently completed. It is a NA study. The enrollment target is 479 participants. The study started on 2014-12-01. Estimated completion is 2018-09-30.
What conditions does trial NCT02501642 study?
This clinical trial studies the following conditions: Concussion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02501642?
The interventions under investigation include: Treatment as usual (OTHER), Concussion Coach (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02501642?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02501642 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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