Smart Phone Application for Postconcussion Symptom Reduction

NCT02501642 | Completed Results

• 1 other identifier: IIR 13-196
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 2

Brief 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. 1.Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of TBI Coach.
2. 2.Determine the aspects of TBI Coach most associated with positive outcomes.
3. 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

Outcome Measures

Primary Outcomes (1)

• Neurobehavioral Symptom Inventory

  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.

  3 months

Study Arms (2)

Concussion Coach group

EXPERIMENTAL

After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach "Explorer" version

Behavioral: Concussion Coach

Treatment as usual

OTHER

Treatment as usual

Other: Treatment as usual

Interventions

Concussion Coach BEHAVIORAL

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

Concussion Coach group

Treatment as usual OTHER

Treatment as usual

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who report prior experience with Concussion Coach will also be excluded

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33744-0000, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Bradley SE, Haun J, Powell-Cope G, Haire S, Belanger HG. Qualitative assessment of the use of a smart phone application to manage post-concussion symptoms in Veterans with traumatic brain injury. Brain Inj. 2020 Jul 2;34(8):1031-1038. doi: 10.1080/02699052.2020.1771770. Epub 2020 Jun 4.

  PMID: 32493066 RESULT

MeSH Terms

Conditions

Brain Concussion

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Tracy Kretzmer, Ph.D.
• Organization: James A. Haley VA

tracy.kretzmer@va.gov

813-972-2000

Study Officials

• Tracy S Kretzmer, PhD BA

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 17, 2015
• Study Start: December 1, 2014
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 28, 2023
• Results First Posted: October 27, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)