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Smart Phone Application for Postconcussion Symptom Reduction

NCT02501642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2023-07-28

Study results available
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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

  • Concussion

Interventions

BEHAVIORAL

Concussion Coach

smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies

OTHER

Treatment as usual

Treatment as usual

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Tracy S Kretzmer, PhD BA · James A. Haley Veterans' Hospital, Tampa, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02501642 on ClinicalTrials.gov