Spinal Cord Injury Clinical Trial
Official title:
Evaluating the Effectiveness of a Serious Game to Enhance Self-Management Skills Among Adolescents and Young Adults With Spinal Cord Dysfunction
Verified date | February 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 184 |
Est. completion date | September 1, 2017 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 29 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute on Disability, Independent Living, and Rehabilitation Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Frequency & Interval of game play | Transmitted wirelessly while participant is playing the game | Information about dosage of play | |
Secondary | Change in scores on the SCI/D Self-monitoring inventory | Used to assess change over time in self-monitoring | change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) | |
Secondary | Change in scores on the Social Problem Solving Inventory - Revised: Short Form | Used to assess change over time in 4 dimensions of problem solving: negative | change in scores on the SPSI-R from baseline (baseline to 1 month; baseline to 3 months; 1 month to 3 months) | |
Secondary | Change in scores on the Craig Handicap Assessment and Reporting Technique - Short Form (CHART-SF) | Used to assess change over time in impairments and disabilities that result in handicaps in the years after initial rehabilitation. | change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) | |
Secondary | Change in scores on the WHOQOL-BREF (World Health Organization Quality of Life) | Used to assess change over time in specific domains of health related Quality of Life | change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) | |
Secondary | Change in scores on the Spinal Cord Injury Lifestyle Scale | Used to assess change over time in health behaviors that may have an indirect effect on complications | change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months) |
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