Deployment Related Mild Traumatic Brain Injury (mTBI): Incidence, Natural History, and Predictors of Recovery in Soldiers Returning From OIF/OEF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Over time change in Concussive symptoms
研究概览
简要总结
The study will provide evidence on the long term outcomes of mTBI in service members returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will be combined with data on health care utilization and military job performance. The work, symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI, combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at one year. The assessments over time will permit descriptions of symptom changes for these populations. It is likely the study will find similar findings to those of previous civilian studies - that concussive symptoms often resolve within months of injury. However, some soldier subsets may have chronic problems. Determining the incidence and outcomes of individuals with mTBI will assist medical providers in determining the types of follow-ups needed by returning service members and suggest the development of additional treatment interventions. These results may also inform treatment of civilian populations with mTBI.
The three primary hypotheses are:
- Concussive symptoms at the time of return from serving in Afghanistan and Iraq and symptoms persisting 3 months, 6 months, and 12 months after return will be associated with extent of exposure to combat, injury mechanism, associated injuries (co-occuring injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related mTBIs.
- Returning troops reporting concussive symptoms at the time of return from deployment will have more work related problems at each follow-up (including lower rates of return to duty, return to work, and poor quality of work).
- The mTBI screening tool will be sensitive and specific to mTBI when compared to the criterion measure, which is a structured interview conducted by clinicians blinded to the screening results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be returning from deployment in Iraq or Afghanistan
- •Must have been screened for mild TBI on the deployment related study screening tool
- •Must sign an informed consent/HIPAA authorization -
排除标准
- •Returning from deployment for medical reasons, that is, medically evacuated to the Continental US
- •Unable or unwilling to provide informed consent/HIPAA authorization -
结局指标
主要结局
Over time change in Concussive symptoms
时间窗: Baseline; 3 months; 6 months; 12 months
Concussive symptoms are measured with 3 instruments: Neurobehavioral Symptom Inventory; Patient Health Questionnaire; Headache Questionnaire.
Change in Work Related Issues
时间窗: 3 months; 6 months; 12 months
Measures of rates of return to duty; rates of return to work; and military job performance (for subjects remaining in military at follow-up).
次要结局
- Change in Social Interaction(Baseline; 3 months; 6 months; 12 months)
- Alcohol and caffeine use(Baseline; 3 months; 6 months; 12 months)
- Health Utilization(Baseline; 3 months; 6 months; 12 months follow-up)
- Automated Neuropsychological Assessment Metrics (ANAM)(Pre-deployment testing; and upon return from deployment)
研究者
Karen Schwab
Chief, Epidemiology and Research Support
The Defense and Veterans Brain Injury Center