ConcussionNCT02501642
Smart Phone Application for Postconcussion Symptom Reduction
A study testing Concussion Coach and Treatment as usual in people with Concussion, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion
- What is being tested?
- Concussion Coach and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2014to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects who report prior experience with Concussion Coach will also be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744-0000
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
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:
- Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of TBI Coach.
- Determine the aspects of TBI Coach most associated with positive outcomes.
- 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.
Read the detailed description
Patients who meet eligibility criteria and consent to participate in the study will be randomly assigned to one of two arms, either the Concussion Coach group, which will receive an iPod touch® with the Concussion Coach "Explorer" version, or into the no mobile app control group. Study personnel will explain the purpose of the study, complete the informed consent process, obtain the random treatment assignment from a randomization sheet, and introduce the participant to his/her baseline evaluator. The random assignment to intervention will be accomplished in blocks within each site. While small block sizes allow intervention group sizes to be very similar it may make the allocation process predictable. Therefore to reduce selection bias and achieve balance across the intervention arms sequence list of individual assignments by random block sizes will be generated.
Both groups will be assessed in a pre/post intervention design and will be compensated for their time completing study surveys. During the 3 months that they are involved in the study, the intervention group will be sent (via Concussion Coach) reminders to engage with the app on a weekly basis. Their use (e.g., total time spent on each component of the app) will be collected electronically. Both groups will receive care as usual (meaning their regularly scheduled VA appointments and medications). At the completion of the study, both groups will be encouraged to download the App for their own use, with assistance from the study team if needed.
Description of Intervention \& Training The Concussion Coach is designed to provide psychoeducation, self-assessment, and treatment of PCS symptoms following a mild TBI. The PI and three of the co-investigators were co-developers of Concussion Coach. The public-facing Concussion Coach will be available for free download from a public marketplace and available for use with most mobile devices. The application has the advantage of privacy and anonymity, thus addressing the stigma often expressed as a barrier to seeking treatment. A mirror version of the public version, called Concussion Coach "Explorer Version", will be developed within three months and used for this study. Unlike the public version, it will have the capacity to collect usage information, such as length of time spent on each part of the app, self-report ratings of symptoms and distress, and identification of "favorites" among the self-help tools. These data can be uploaded in a de-identified form to a HIPAA compliant server. Other than the ability to collect data, it will be exactly like the "real" Concussion Coach. The Explorer version will be developed by our collaborators, Vertical Product Development, which developed Concussion Coach, PTSD Coach, and PTSD Explorer version. Explorer versions are especially useful as they allow for unobtrusive, highly detailed, real-time data collection without relying on patient self-report. In addition, the Concussion Coach will be an 'opportunistic' exporter of data. It will upload data to the server whenever it has new data and is in a WiFi zone; participants do not have to have a home wireless network. If they never enter a WiFi area, the investigators will collect their data at study termination when the investigators collect the iPod touch®. The investigators will utilize ohmage, an existing open source technology stack, to port the app to the server.
- Conditions
- Concussion
- Being tested
- Concussion Coach, Treatment as usual
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concussion CoachBehavioural
smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies
Treatment as usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Concussion Coach |
| Treatment as usual | Other | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start1 Dec 2014
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tracy S Kretzmer, PhD BA, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501642
- Sponsor's protocol ID
- IIR 13-196
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2015
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To allow collaboration of information with other interested parties who may be researching the use of Apps for TBI Veterans.
Publications
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.
PubMed 32493066
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Phone Application for Postconcussion Symptom Reduction
- ClinicalTrials.gov ID
- NCT02501642
- Acronym / sponsor ID
- IIR 13-196
- Conditions
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of TBI Coach.
- Determine the aspects of TBI Coach most associated with positive outcomes.
- 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.
Detailed description
Patients who meet eligibility criteria and consent to participate in the study will be randomly assigned to one of two arms, either the Concussion Coach group, which will receive an iPod touch® with the Concussion Coach "Explorer" version, or into the no mobile app control group. Study personnel will explain the purpose of the study, complete the informed consent process, obtain the random treatment assignment from a randomization sheet, and introduce the participant to his/her baseline evaluator. The random assignment to intervention will be accomplished in blocks within each site. While small block sizes allow intervention group sizes to be very similar it may make the allocation process predictable. Therefore to reduce selection bias and achieve balance across the intervention arms sequence list of individual assignments by random block sizes will be generated.
Both groups will be assessed in a pre/post intervention design and will be compensated for their time completing study surveys. During the 3 months that they are involved in the study, the intervention group will be sent (via Concussion Coach) reminders to engage with the app on a weekly basis. Their use (e.g., total time spent on each component of the app) will be collected electronically. Both groups will receive care as usual (meaning their regularly scheduled VA appointments and medications). At the completion of the study, both groups will be encouraged to download the App for their own use, with assistance from the study team if needed.
Description of Intervention \& Training The Concussion Coach is designed to provide psychoeducation, self-assessment, and treatment of PCS symptoms following a mild TBI. The PI and three of the co-investigators were co-developers of Concussion Coach. The public-facing Concussion Coach will be available for free download from a public marketplace and available for use with most mobile devices. The application has the advantage of privacy and anonymity, thus addressing the stigma often expressed as a barrier to seeking treatment. A mirror version of the public version, called Concussion Coach "Explorer Version", will be developed within three months and used for this study. Unlike the public version, it will have the capacity to collect usage information, such as length of time spent on each part of the app, self-report ratings of symptoms and distress, and identification of "favorites" among the self-help tools. These data can be uploaded in a de-identified form to a HIPAA compliant server. Other than the ability to collect data, it will be exactly like the "real" Concussion Coach. The Explorer version will be developed by our collaborators, Vertical Product Development, which developed Concussion Coach, PTSD Coach, and PTSD Explorer version. Explorer versions are especially useful as they allow for unobtrusive, highly detailed, real-time data collection without relying on patient self-report. In addition, the Concussion Coach will be an 'opportunistic' exporter of data. It will upload data to the server whenever it has new data and is in a WiFi zone; participants do not have to have a home wireless network. If they never enter a WiFi area, the investigators will collect their data at study termination when the investigators collect the iPod touch®. The investigators will utilize ohmage, an existing open source technology stack, to port the app to the server.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion Coach group | Experimental | Behavioral: Concussion CoachAfter informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach "Explorer" version |
| Treatment as usual | Other | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who report prior experience with Concussion Coach will also be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concussion Coachsmart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies | Behavioural | Concussion Coach group |
| Treatment as usualTreatment as usual | Other | Treatment as usual |
Primary outcome
Neurobehavioral Symptom Inventory
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32493066Bradley 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.
- Individual participant dataSharing planned: Yes. To allow collaboration of information with other interested parties who may be researching the use of Apps for TBI Veterans.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy S Kretzmer, PhD BA principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concussion Coach and Treatment as usual in people with Concussion, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptom Inventory (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.