ConcussionSuperBetterNCT01398566
Clinical Trial of a Rehabilitation Game - SuperBetter
A study testing SuperBetter play in people with Concussion and Mild Traumatic Brain Injury, run by Ohio State University at 1 site in United States.
Trial summary
Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Concussion, Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury
- What is being tested?
- SuperBetter play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2015
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients: between 15 and 25 years old
- diagnosed within the last year with at least one traumatic brain injury (mild or moderate)
- subjective report of less than complete recovery from the injury
- easy access to computer with internet access
- compatible web browser (such as the latest version of Internet Explorer, Chrome, Firefox or other as determined by developers)
- has a support giver (18 or over) who is willing to participate in this study also
Who cannot join
- ● history of substance abuse as self reported by patient or reported by support giver
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Physical Medicine and Rehabilitation Department
Columbus, Ohio, 43210
About this study
Official title: Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)
Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. The period of time immediately following discharge is an under-addressed stage within the continuum of care. The investigators are researching solutions to help patients in this transition to self-care and believe that multiplayer gaming paradigms may be a promising innovation to facilitate this transition.
The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games like it, are promising novel interventions that could make a positive difference in the ability of our patients to successfully transition to self care after discharge from therapeutic care.
Specifically, the investigators will evaluate feasibility of use of such a game by mild to moderate brain injured individuals and to record pilot data to help us plan a clinical effectiveness follow up study. Our goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.
Read the detailed description
Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. The period of time immediately following discharge is an under-addressed stage within the continuum of care. The investigators are researching solutions to help patients in this transition to self-care and believe that multiplayer gaming paradigms may be a promising innovation to facilitate this transition for several reasons:
- Games can bring the power of social networks and alternate reality to bear on the real world work of post-injury self-management.
- Games can use a digital platform, enabling quantification of performance in ways that could provide clinically-relevant documentation for post-discharge follow up efforts including tele-rehabilitation.
- Today's youth are gamers. The investigators aim to tailor our rehabilitative approaches to leverage the existing ability of our youth in this paradigm. In addition, Dr. Jane McGonigal reports in her book, Reality is Broken, that within another decade the majority of the world's population will likely be gamers. The investigators aim to anticipate this shift and be ready for it.
- Affordable games have the potential to be cost-effective aids and improvements over standard medical care protocols.
Despite the promise of games to facilitate transitions from hospital care to self care, no clinical studies have been done to establish best practices for applying gaming for rehabilitative purposes within the specific window of time in which discharge from standard care happens. While some commercially available games exist for those interested in health self-improvement, through companies such as That Game Company, Nintendo, Xbox, only the Nintendo Wii system has undergone clinical testing to demonstrate feasibility of use within the hospital-based model of patient care. Without more such evidence, the investigators are unable to confidently offer such novel interventions for our patients.
A new game, SuperBetter (SuperBetter, LLC, Sausilito, CA), has been developed to employ both social networking and alternate reality theory to achieve rehabilitative goals. SuperBetter is most similar to Facebook or Twitter in that users, or "gamers", create an account, invite others to be within their network, and post short status update messages. There are two major differences between SuperBetter and Twitter or Facebook, however. One difference is that this rehabilitation game will not offer a public option. The only people who can see a user's posts and status updates will have been specifically invited by that gamer; people outside the invited network will have no ability to "friend" a gamer, meaning there is no way to request to become part of a user's network - you must be invited by the account holder. The second difference is that SuperBetter assigns points to a gamer for attaining health goals such as: remembering to take medications each day; avoiding circumstances that exacerbate symptoms; checking in with someone within your trusted network (i.e. reaching out to your loved ones for support). Points are also assigned for "epic wins" which are defined by the patient and amount to things he or she cannot do today but want to be able to do tomorrow; this includes short term wins like hanging out with friends/loved ones or long term wins like getting back to playing sports.
The investigators believe that McGonigal's SuperBetter, and positive play games like it, are promising novel interventions that could make a positive difference in the ability of our patients to successfully transition to self care after discharge from therapeutic care. The investigators are conducting Phase I clinical testing (feasibility) to determine whether such a rehabilitation game is appropriate for use with: mild traumatic brain injured children and teens.
Specifically, the investigators will evaluate feasibility of use of such a game by mild traumatic brain injured individuals and to record pilot data to help us plan a clinical effectiveness follow up study. Our goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.
- Being tested
- SuperBetter play
- Keywords
- TBI, concussion, brain injury
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperBetter playBehavioural
average 10 min of game play per day for 6 week period
| Study group | Role | What they receive |
|---|---|---|
| SuperBetter Play | Experimental | members of this group will play SuperBetter for 6 weeks (averaging 10 min per day of play for 6 week period) Receives: Behavioral: SuperBetter play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Number of Participants who used the app and returned for post testing
Measured: 8 weeks
Secondary outcomes (1)
Satisfaction With App
Satisfaction rating on a 7 point Likert scale ranging from 1 (very satisfied) to 7 (very dissatisfied) among those who used the app and returned for post testing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
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.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Worthen-Chaudhari, Ohio State University
- Investigators
- Lise Worthen-Chaudhari, MFA,MS,CCRC, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398566
- Sponsor's protocol ID
- 2011H0077
- Acronym
- SuperBetter
- Status last verified
- Mar 2021
- First submitted
- 19 Jul 2011
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)
- ClinicalTrials.gov ID
- NCT01398566
- Acronym / sponsor ID
- SuperBetter / 2011H0077
- Keywords
- TBI, concussion, brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. The period of time immediately following discharge is an under-addressed stage within the continuum of care. The investigators are researching solutions to help patients in this transition to self-care and believe that multiplayer gaming paradigms may be a promising innovation to facilitate this transition.
The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games like it, are promising novel interventions that could make a positive difference in the ability of our patients to successfully transition to self care after discharge from therapeutic care.
Specifically, the investigators will evaluate feasibility of use of such a game by mild to moderate brain injured individuals and to record pilot data to help us plan a clinical effectiveness follow up study. Our goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.
Detailed description
Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. The period of time immediately following discharge is an under-addressed stage within the continuum of care. The investigators are researching solutions to help patients in this transition to self-care and believe that multiplayer gaming paradigms may be a promising innovation to facilitate this transition for several reasons:
- Games can bring the power of social networks and alternate reality to bear on the real world work of post-injury self-management.
- Games can use a digital platform, enabling quantification of performance in ways that could provide clinically-relevant documentation for post-discharge follow up efforts including tele-rehabilitation.
- Today's youth are gamers. The investigators aim to tailor our rehabilitative approaches to leverage the existing ability of our youth in this paradigm. In addition, Dr. Jane McGonigal reports in her book, Reality is Broken, that within another decade the majority of the world's population will likely be gamers. The investigators aim to anticipate this shift and be ready for it.
- Affordable games have the potential to be cost-effective aids and improvements over standard medical care protocols.
Despite the promise of games to facilitate transitions from hospital care to self care, no clinical studies have been done to establish best practices for applying gaming for rehabilitative purposes within the specific window of time in which discharge from standard care happens. While some commercially available games exist for those interested in health self-improvement, through companies such as That Game Company, Nintendo, Xbox, only the Nintendo Wii system has undergone clinical testing to demonstrate feasibility of use within the hospital-based model of patient care. Without more such evidence, the investigators are unable to confidently offer such novel interventions for our patients.
A new game, SuperBetter (SuperBetter, LLC, Sausilito, CA), has been developed to employ both social networking and alternate reality theory to achieve rehabilitative goals. SuperBetter is most similar to Facebook or Twitter in that users, or "gamers", create an account, invite others to be within their network, and post short status update messages. There are two major differences between SuperBetter and Twitter or Facebook, however. One difference is that this rehabilitation game will not offer a public option. The only people who can see a user's posts and status updates will have been specifically invited by that gamer; people outside the invited network will have no ability to "friend" a gamer, meaning there is no way to request to become part of a user's network - you must be invited by the account holder. The second difference is that SuperBetter assigns points to a gamer for attaining health goals such as: remembering to take medications each day; avoiding circumstances that exacerbate symptoms; checking in with someone within your trusted network (i.e. reaching out to your loved ones for support). Points are also assigned for "epic wins" which are defined by the patient and amount to things he or she cannot do today but want to be able to do tomorrow; this includes short term wins like hanging out with friends/loved ones or long term wins like getting back to playing sports.
The investigators believe that McGonigal's SuperBetter, and positive play games like it, are promising novel interventions that could make a positive difference in the ability of our patients to successfully transition to self care after discharge from therapeutic care. The investigators are conducting Phase I clinical testing (feasibility) to determine whether such a rehabilitation game is appropriate for use with: mild traumatic brain injured children and teens.
Specifically, the investigators will evaluate feasibility of use of such a game by mild traumatic brain injured individuals and to record pilot data to help us plan a clinical effectiveness follow up study. Our goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SuperBetter Play | Experimental | Behavioral: SuperBetter playmembers of this group will play SuperBetter for 6 weeks (averaging 10 min per day of play for 6 week period) |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients: between 15 and 25 years old
- diagnosed within the last year with at least one traumatic brain injury (mild or moderate)
- subjective report of less than complete recovery from the injury
- easy access to computer with internet access
- compatible web browser (such as the latest version of Internet Explorer, Chrome, Firefox or other as determined by developers)
Key exclusion criteria (1 listed)
- ● history of substance abuse as self reported by patient or reported by support giver
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 |
|---|---|---|
| SuperBetter playaverage 10 min of game play per day for 6 week period | Behavioural | SuperBetter Play |
Primary outcome
Participation
Time frame: 8 weeks
Number of Participants who used the app and returned for post testing
1 secondary outcome
Satisfaction With App
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor websiteLink provided by the sponsor.
- Game designer websiteLink provided by the sponsor.
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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.
Lise Worthen-Chaudhari, MFA,MS,CCRC principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperBetter play in people with Concussion and Mild Traumatic Brain Injury, run by Ohio State University at 1 site 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 6 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 6 Apr 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?
Participation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2021.