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

Brief Title

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

Official Title

Evaluating the Effectiveness of a Serious Game to Enhance Self-Management Skills Among Adolescents and Young Adults With Spinal Cord Dysfunction

Brief Summary

      This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to enhance
      self-management skills, self-reported health behaviors, and quality of life 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 (University of Michigan three
      dimensional) 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).

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Change in scores on the Appraisals of Disability: Primary and Secondary Scale (ADAPSS) (used to assess change over time)

Secondary Outcome

 Frequency & Interval of game play

Condition

Spinal Cord Injury

Intervention

SCI Hard

Study Arms / Comparison Groups

 SCI Hard
Description:  This arm plays the SCI HARD game

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

184

Start Date

February 5, 2015

Completion Date

September 1, 2017

Primary Completion Date

September 1, 2017

Eligibility Criteria

        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.
      

Gender

All

Ages

13 Years - 29 Years

Accepts Healthy Volunteers

No

Contacts

Michelle A Meade, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02341950

Organization ID

UM-RERC-82972


Responsible Party

Principal Investigator

Study Sponsor

University of Michigan

Collaborators

 National Institute on Disability, Independent Living, and Rehabilitation Research

Study Sponsor

Michelle A Meade, PhD, Principal Investigator, University of Michigan


Verification Date

February 2019