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

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ClinicalTrials.gov Identifier: NCT02341950
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Michelle Meade, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Spinal Cord Involvement Spina Bifida Transverse Myelitis Polio and Post-polio Syndrome Syringomyelia Spinal Stenosis Spinal Neoplasms Spinal Cord Diseases Behavioral: SCI Hard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Effectiveness of a Serious Game to Enhance Self-Management Skills Among Adolescents and Young Adults With Spinal Cord Dysfunction
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017


Arm Intervention/treatment
Experimental: SCI Hard
This arm plays the SCI HARD game
Behavioral: SCI Hard
The game SCI Hard is designed to enhance self-management skills in individuals with spinal cord injury

No Intervention: Control
Plays an alternate, publicly available game



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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".


Secondary Outcome Measures :
  1. Frequency & Interval of game play [ Time Frame: Information about dosage of play ]
    Transmitted wirelessly while participant is playing the game

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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



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Ages Eligible for Study:   13 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341950


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Michelle A Meade, PhD University of Michigan
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Responsible Party: Michelle Meade, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02341950    
Other Study ID Numbers: UM-RERC-82972
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data is not planned to be released.
Keywords provided by Michelle Meade, University of Michigan:
videogame
health
behavior
mobile
spinal
cord
dysfunction
Additional relevant MeSH terms:
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Myelitis
Myelitis, Transverse
Postpoliomyelitis Syndrome
Spinal Neoplasms
Spinal Stenosis
Spinal Cord Injuries
Spinal Dysraphism
Spinal Cord Diseases
Syringomyelia
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Poliomyelitis
Central Nervous System Infections
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Neuromuscular Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site