Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01398566 |
| Other study ID # |
2011H0077 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2014 |
| Est. completion date |
January 2015 |
Study information
| Verified date |
March 2021 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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:
1. Games can bring the power of social networks and alternate reality to bear on the real
world work of post-injury self-management.
2. 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.
3. 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.
4. 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.
