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Clinical Trial of a Rehabilitation Game - SuperBetter

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Lise Worthen-Chaudhari, Ohio State University
ClinicalTrials.gov Identifier:
NCT01398566
First received: July 19, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Concussion
Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury
Behavioral: SuperBetter play
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Community participation measures [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Does this web-based, multi-player game enhance or hinder community participation among individuals recovering from concussion (mild to moderate traumatic brain injury)?


Secondary Outcome Measures:
  • Quality of Life Scale for both patient & primary support giver [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Do patient and/or support giver report that quality of life is reduced, improved, or stays the same over the course of participation in this gaming intervention.


Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gaming
members of this group will play SuperBetter for 6 weeks (averaging 10 min per day of play for 6 week period)
Behavioral: SuperBetter play
average 10 min of game play per day for 6 week period

  Hide Detailed Description

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:

  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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

● history of substance abuse as self reported by patient or reported by support giver

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398566

Contacts
Contact: Lise Worthen-Chaudhari, MFA, MS 614-293-6281 lise.worthen-chaudhari@osumc.edu
Contact: Ohio State Research Hotline 614-293-HERO

Locations
United States, Ohio
The Ohio State University Physical Medicine and Rehabilitation Department Recruiting
Columbus, Ohio, United States, 43210
Contact: Lise Worthen-Chaudhari, MFA, MS    614-293-6281    lise.worthen-chaudhari@osumc.edu   
Contact: Ohio State Research Hotline    614-293-HERO      
Principal Investigator: W Mysiw, MD         
Sub-Investigator: Lise Worthen-Chaudhari, MFA, MS         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Lisa Worthen-Chaudhari, MFA,MS,CCRC Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Lise Worthen-Chaudhari, Research Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01398566     History of Changes
Other Study ID Numbers: 2011H0077
Study First Received: July 19, 2011
Last Updated: May 12, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Ohio State University:
TBI
concussion
brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014