Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 234
- 试验地点
- 6
- 主要终点
- Score on the Advocacy Behavior Rating Scale
研究概览
简要总结
The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.
It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •moderate-severe TBI as indicated by one of the following:
- •post traumatic amnesia (PTA) > 24 hours
- •or loss of consciousness > 30 minutes
- •or neuroimaging evidence of trauma-related intracranial abnormality
- •Or the family/significant other of an individual with TBI meeting the above criteria
- •1 or more years post-injury
- •Functional English speaker
- •Signed consent to participate
排除标准
- •Severe cognitive impairment as indicated by one or more of the following:
- •Disorientation to person or year
- •Unable to complete pre-program interview because of severe communication limitations
- •Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
- •Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer
结局指标
主要结局
Score on the Advocacy Behavior Rating Scale
时间窗: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
次要结局
- Score on Advocacy Activity Scale(The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.)
- Score on the Perceived Control Scale for Brain Injury(The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.)
- The Craig Hospital Inventory of Environmental Factors-Short Form(The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.)
- The Satisfaction with Life Scale(The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.)
- The SF-12(The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.)
- Advocacy Activity Scale(Every 6 months after intervention until the end of the 5-year study period)
研究者
Allen Brown
Director, Brain Rehabilitation Research
Mayo Clinic