NCT01398566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
2.8 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

July 19, 2011

Results QC Date

September 18, 2017

Last Update Submit

March 11, 2021

Conditions

ConcussionMild Traumatic Brain InjuryModerate Traumatic Brain Injury

Keywords

TBIconcussionbrain injury

Outcome Measures

Primary Outcomes (1)

  • Participation

    Number of Participants who used the app and returned for post testing

    8 weeks

Secondary Outcomes (1)

  • Satisfaction With App

    8 weeks

Study Arms (1)

SuperBetter Play

EXPERIMENTAL

members of this group will play SuperBetter for 6 weeks (averaging 10 min per day of play for 6 week period)

Behavioral: SuperBetter play

Interventions

SuperBetter playBEHAVIORAL

average 10 min of game play per day for 6 week period

SuperBetter Play

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Physical Medicine and Rehabilitation Department

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Brain ConcussionBrain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Results Point of Contact

Title
Lise Worthen-Chaudhari
Organization
The Ohio State University
liseworthen@gmail.com
614-304-1421

Study Officials

  • Lise Worthen-Chaudhari, MFA,MS,CCRC

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 6, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-03

Locations

US(1)