Clinical Trial of a Serious Game for Individuals With SCI/D

This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to enhance
self-management skills, self-reported health behaviors, and QOL among adolescents and young
adults with spinal cord injury and disease (SCI/D). SCI HARD was designed by the project PI,
Dr. Meade, in collaboration with the UM3D Lab between 2010 and 2013 with funding from a NIDRR
(National Institute on Disability and Rehabilitation Research) Field Initiated Development
Grant to assist persons with SCI develop and apply the necessary skills to keep their bodies
healthy while managing the many aspects of SCI care. The study makes a unique contribution to
rehabilitation by emphasizing the concepts of personal responsibility and control over one's
health and life as a whole. By selecting an innovative approach for program implementation,
we also attempt to address the high cost of care delivery and lack of health care access to
underserved populations with SCI/D living across the United States (US).

BACKGROUND AND LITERATURE REVIEW As defined by the computer gaming industry, a serious game
is "a game designed for a primary purpose other than pure entertainment." Serious games based
on development of self-management skills have been developed for asthma, diabetes, safe sex
negotiation, and promoting nutrition and physical activities. They have been effective in
improving self-care, increasing self-efficacy, reducing symptoms, minimizing secondary
conditions, reducing emergency room visits and decreasing health care costs.

The game application being assessed in this project is based on the self-management
principles and specifically on the Health Mechanics Program, an evidence-based
self-management program which was developed by Dr. Meade. Many of the individuals who sustain
traumatic SCI are from the millennial generation. While the mean age for individuals with SCI
is 40.2 years old, approximately half are in the 16 to 29 age range at the time of injury.
Younger patients with traumatic SCI are overwhelmingly male, many of whom need medical care
for the first time in their lives. These individuals are likely to be single (never-married)
and many have a high-school education or less. A significant component of this group was
injured through participation in high-risk behaviors or acts of violence; the group tends to
have lower literacy levels and fewer resources, with many being from ethnic and racial
minority backgrounds.

As previously discussed, individuals in this group, tend to have a high degree of technical
sophistication which can be leveraged to promote the transfer of knowledge and
self-management skills. In particular, games that can be downloaded and played on a mobile
platform, such as a smartphone, are likely to be accessed and played by members of this
group.

Data from the Pew Internet and American Life Project indicates that most Americans age 16 to
24 play computer or electronic games - including 97% of American teenagers and 81% of adults
18 to 29 years old. African Americans appear equally likely to play electronic games as
Non-Hispanic Whites (both 51%) while English-Speaking Hispanics appear more likely to do so
(63%; though that was attributed to the youth of the group). While most adult gamers play on
the computers (73%), teens and young adults are increasingly playing on portable gaming
devices (62%) and cell phones (50%). African Americans and Hispanics are more likely than
non-Hispanic, Whites to play games on smaller, mobile gadgets. 55% of teens own a portable
gaming device, 74% own an iPod or MP3 player, and 60% have a desktop or laptop computer.

Data from a recent survey conducted by Dr. Meade and her colleague confirms the use of
technology by individuals with SCI. They sent a mail survey to the population of individuals
with SCI ages 8 and older who were identified as being treated at the U-M within the past 10
years. Among those individuals who appeared to have valid addresses (n=780), approximately
40% (n=317) responded. While most of these individuals owned a computer and many owned other
types of devices, more than half of 13 to 29 year olds owned or used a mobile device that
could be used for gaming (e.g., iPad, iPhone, Android table / phone).

INTERVENTION SCI HARD was designed based on the needs and strengths of individuals with SCI/D
while being responsive to identified gaps and challenges in health care provision in this
population. Current theories of health behavior and standard practices for game development
shaped its development. In particular, we referred to the previously described model proposed
by Ritterband et al. for behavior change using internet interventions and prioritized fun and
engagement in the design process. The program focuses on enhancing skills, encouraging
positive health behaviors and empowering people within their own environments, recognizing
that people have different resources and abilities. By teaching skills to better manage
health, this self-management program should not only reduce the occurrence of complications
but should also promote higher levels of social integration and QOL. In particular, playing
the game should allow players to recognize the consequences of their behaviors as actions and
inactions are tied to visible results and substantial changes in statistics.

As currently developed, SCI Hard is available on both IOS (Apple Mobile Operating System) and
Android platforms. Play time is approximately 5 hours and requires individuals to be able to
successfully manage their health before they will be able to complete all levels.

Purpose and Objectives The overall purpose is to evaluate the effects of the serious game SCI
Hard on self-management skills, positive health behaviors and QOL. The program specifically
targets adolescents and young adult with SCI/D.

Objectives are: 1) to improve self-management skills, including problem-solving, attitude
about disability, and self-efficacy for managing health; 2) to increase performance of
recommended health management behaviors; 3) to improve QOL; and 4) to determine the extent
that dosage of game play impacts changes in any of these factors. .

All hypotheses posit that, following the intervention, differences will exist such that
participants in the SCI Hard will show more positive outcomes than the control group members
(an assessment of between group differences) and that these differences will be sustained
over time (an assessment of within and between group differences). It is expected that, for
the intervention group, degree of engagement with the game (or dosage or play time) will
influence degree of improvements, thus our interest in examining within group differences.

Research Hypotheses H1: SCI Hard participants will show greater improvements in problem
solving skills, healthy attitudes about disability, and SCI Self-efficacy than will control
group members; these improvements will be sustained over time within and between groups.

H2: SCI Hard participants will endorse more positive health behaviors than control group
members; these improvements will be sustained over time within and between groups.

H3: SCI Hard participants will have higher levels of QOL than control group members; these
differences will be sustained over time within and between groups.

H4: Among SCI Hard participants, dosage of game play will be related to degree of change in
self-management skills, health behaviors and QOL.

Inclusion Criteria:

- between the ages of 13 and 29

- have a spinal cord dysfunction

- have access to a mobile device on which they can download and play the game

- be English-speaking.

Exclusion Criteria:

- high degrees of emotional distress, suicidal intent, or anxiety (as determined by the
Patient Health Questionnaire-Depression Module (PHQ-9) and Generalized Anxiety
Disorder-7(GAD-7)). Individuals will also be required to answer questions to confirm
that they understand the study as part of the informed consent process.