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临床试验/NCT02341950
NCT02341950已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2015年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
2
主要终点
Change in scores on the Appraisals of Disability: Primary and Secondary Scale (ADAPSS) (used to assess change over time)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

SCI Hard

Experimental

This arm plays the SCI HARD game

干预措施: SCI Hard (Behavioral)

Control

No Intervention

Plays an alternate, publicly available game

结局指标

主要结局

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

时间窗: 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 Effective Consumer Scale

时间窗: 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".

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

时间窗: 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

次要结局

  • Frequency & Interval of game play(Information about dosage of play)
  • 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))
  • 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 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 Spinal Cord Injury Lifestyle Scale(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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Meade

Associate Professor

University of Michigan

研究点 (2)

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