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NCT02501642 · ClinicalTrials.gov registry record · NA
Smart Phone Application for Postconcussion Symptom Reduction
A NA study of Concussion, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 479
- Enrollment target
- 2
- Study locations
NCT02501642: Completed NA study of Concussion, sponsored by VA Office of Research and Development.
NCT02501642 is a NA study of Concussion that has completed, run by VA Office of Research and Development. The registered enrollment target is 479 participants, above the 92-participant average among 9 other Concussion trials with a reported enrollment target (421% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02501642, a NA study of Concussion, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 479 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The Neurobehavioral Symptom Inventory is a 22-item questionnaire developed to evaluate post-concussive symptom severity following mild TBI (Cicerone and Kalmar 1995). Participants are asked to rate each symptom on a scale of 0-4 (None, Mild, Moderate, Severe, Very Severe) with three different categories of symptoms: Affective/psychological/stress, somatic/physical and cognitive (reflecting three factors). Scores can range from 0-88, with higher scores indicating more severe symptom endorsement.
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 |
What the finished NCT02501642 record still lists
NCT02501642 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 9 other Concussion trials with a reported enrollment target (421% higher).
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.
NCT02501642 reports a single indexed study location in Florida.
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.
What interventions are being tested in trial NCT02501642?
The interventions under investigation include: Treatment as usual (OTHER), Concussion Coach (BEHAVIORAL).
Who is sponsoring clinical trial NCT02501642?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02501642's enrollment target sits among peer trials
479 1st of 9 higher than 9 of 9 other Concussion trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Concussion trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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