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

NCT02341950 | Completed

• 1 other identifier: UM-RERC-82972
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Spinal Cord Involvement; Spina Bifida; Transverse Myelitis; Polio and Post-polio Syndrome; Syringomyelia; Spinal Stenosis; Spinal Neoplasms; Spinal Cord Diseases

Keywords

videogame; health; behavior; mobile; spinal; cord; dysfunction

Outcome Measures

Primary Outcomes (3)

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

  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 scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

• Change in scores on the Disability Management Self-Efficacy Scale - Short

  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 scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

• Change in scores on the Effective Consumer Scale

  Used to assess change over time in how effective people are at dealing with their chronic condition and making decisions about their health care".

  change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

Secondary Outcomes (6)

• Frequency & Interval of game play

  Information about dosage of play

• Change in scores on the SCI/D Self-monitoring inventory

  change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

• Change in scores on the Social Problem Solving Inventory - Revised: Short Form

  change in scores on the SPSI-R from baseline (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

• Change in scores on the Craig Handicap Assessment and Reporting Technique - Short Form (CHART-SF)

  change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

• Change in scores on the WHOQOL-BREF (World Health Organization Quality of Life)

  change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)

Study Arms (2)

SCI Hard

EXPERIMENTAL

This arm plays the SCI HARD game

Behavioral: SCI Hard

Control

NO INTERVENTION

Plays an alternate, publicly available game

Interventions

SCI Hard BEHAVIORAL

The game SCI Hard is designed to enhance self-management skills in individuals with spinal cord injury

SCI Hard

Eligibility Criteria

• Age: 13 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Dysraphism; Myelitis, Transverse; Postpoliomyelitis Syndrome; Syringomyelia; Spinal Stenosis; Spinal Neoplasms; Spinal Cord Diseases; Behavior; Cone-Rod Dystrophies

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases; Immune System Diseases; Poliomyelitis; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Spinal Diseases; Bone Diseases; Bone Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn

Study Officials

• Michelle A Meade, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 19, 2015
• Study Start: February 5, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)