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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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, hea

Detailed 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 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. Whil
Sponsor: University of Michigan

Current Primary Outcome:

  • Change in scores on the Appraisals of Disability: Primary and Secondary Scale (ADAPSS) (used to assess change over time) [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in six dimensions of appraisal: fearful despondency, overwhelming disbelief, determined resolve, growth and resilience, negative perceptions of disability, and personal agency.
  • Change in scores on the Disability Management Self-Efficacy Scale - Short [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in the extent that the person with a SCI feels they can manage their health and keeping it from interfering with their life
  • Change in scores on the Effective Consumer Scale [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in how effective people are at dealing with their chronic condition and making decisions about their health care".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency & Interval of game play [ Time Frame: Information about dosage of play ]
    Transmitted wirelessly while participant is playing the game
  • Change in scores on the SCI/D Self-monitoring inventory [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in self-monitoring
  • Change in scores on the Social Problem Solving Inventory - Revised: Short Form [ Time Frame: change in scores on the SPSI-R from baseline (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in 4 dimensions of problem solving: negative
  • Change in scores on the Craig Handicap Assessment and Reporting Technique - Short Form (CHART-SF) [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in impairments and disabilities that result in handicaps in the years after initial rehabilitation.
  • Change in scores on the WHOQOL-BREF (World Health Organization Quality of Life) [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in specific domains of health related Quality of Life
  • Change in scores on the Spinal Cord Injury Lifestyle Scale [ Time Frame: change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) ]
    Used to assess change over time in health behaviors that may have an indirect effect on complications


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: December 16, 2014
Date Started: February 5, 2015
Date Completion: September 2017
Last Updated: May 15, 2017
Last Verified: May 2017