Veteran's Interdisciplinary Care for Traumatic Brain Injury & Co-Occurring Disorders Rehabilitation Trial - A Pragmatic, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 416
- 主要终点
- Mean change in Neurobehavioral Symptom Inventory (NSI)
研究概览
简要总结
The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can reduce long-lasting symptoms of traumatic brain injury (TBI) and co-occurring disorders in veterans and first responders. The main questions it aims to answer are:
- Does a 3-week IORP reduce symptoms of long-lasting TBI and co-occurring disorders in military veterans and first responders?
- Does the 3-week IORP improve life quality and function in military veterans and first responders?
Researchers will compare the Control group to the Invention group to see if a 3-week of IORP reduced symptoms of TBI and co-occurring disorders in military veterans and first responders.
Participants will complete the following activities. The items with an asterisk(*) are not required or available at all sites.
- Answer online survey questions about their TBI symptoms, life satisfaction, and life activities
- Complete two blood draws*
- Complete two magnetic resonance imaging (MRI) brain scans*
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets general eligibility requirements for site specific 3-week IORP
- •Capable of providing informed consent for IORP and study participation
- •English speaking
- •18 to 65 years old
排除标准
- •History of TBI of any severity in the past 6 months
- •Active substance use disorder that precludes study participation
- •Neurologic, psychiatric, or other medical condition that would prohibit full study participation
- •Active-duty military service member
- •Any other circumstance that, in the opinion of the investigator, would undermine the integrity or success of the project
研究组 & 干预措施
Interdisciplinary Outpatient Rehabilitation Program Intervention Arm
Participants in this arm will start the 3-Week TBI IORP after baseline evaluation and receiving the recommendation to participate in the IORP.
干预措施: 3-week interdisciplinary outpatient rehab program (IORP) (Behavioral)
Control Waiting Period Arm
Participants in this arm will start the 3-Week TBI IORP after observing at least a 3 month waiting period after baseline evaluation and receiving the recommendation to participate in the IORP.
干预措施: 3-week interdisciplinary outpatient rehab program (IORP) (Behavioral)
结局指标
主要结局
Mean change in Neurobehavioral Symptom Inventory (NSI)
时间窗: Baseline enrollment to 3-month follow-up (post IORP)
The NSI is a 22-item self-report questionnaire used to assess neurobehavioral symptoms, particularly those following a TBI
次要结局
- Mean change in Satisfaction with Life Scale (SWLS)(Baseline enrollment to 3 months post-IORP and 6 months post-IORP)
- Life Satisfaction Questionnaire (LISAT-11)(Baseline enrollment to 3 months post-IORP and 6 months post-IORP)
- Participation Assessment with Recombined Tools-Objective (PART-O)(Baseline enrollment to 3 months post-IORP and 6 months post-IORP)
研究者
Michael McCrea
Professor of Neurosurgery
Medical College of Wisconsin