Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Weekly working hours
研究概览
简要总结
The investigators aim to investigate the impact of interdisciplinary and individually tailored programs for mTBI (concussion) on quality of life and work capacity, both at the conclusion of the program and after 1 and 3 years. The investigators also want to examine whether early intervention is significant by comparing individuals who enter the program between 1 and 3 months post-concussion with those who only start the program more than 9 months post-concussion. Such a study has not been conducted before and can provide valuable insights into long-term effects and the importance of early intervention
详细描述
A concussion typically results from a trauma to the head or body and, for most people, causes symptoms that resolve within a few weeks. Approximately 25,000 individuals in Denmark experience concussions annually. However, about 8,000 to 11,000 of those affected experience prolonged symptoms such as fatigue, dizziness, headaches, pain, and cognitive impairments. These symptoms can significantly reduce quality of life and work capacity, and in some cases, become chronic. Consequently, a subset of individuals with concussions require ongoing social support even two years post-injury.
Denmark currently lacks a comprehensive national guideline for managing concussions within regional and municipal healthcare systems. As a result, individuals with concussions are often left to navigate the healthcare system on their own, leading to limited or no access to rehabilitation services. The Danish Center for Concussion and other experts have recommended the establishment of national concussion clinics.
Since 2016, the Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry, has been developing and providing concussion interventions based on national and international evidence. Participants in these programs have reported significant improvements in weekly work hours and overall quality of life. However, the long-term effects of these interventions remain unknown.
Participants are typically in great distress and need help, which is why a lack of interventions-or the delay of interventions for several months-in a control group is considered unethical. It should be noted that single-group studies, which evaluate outcomes longitudinally, are often the only possible method and can provide both interesting and reliable results. Investigators will be blinded for participants being allocated to early or late interventions.
This single-center and uncontrolled study aims to investigate the long-term impact of interdisciplinary and personalized concussion rehabilitation programs on quality of life and work capacity. Researchers will compare the outcomes of individuals who begin the program within 1-3 months post-concussion to those who start later (more than 9 months post-concussion) to determine the significance of early intervention. This research is groundbreaking as it will provide valuable insights into the long-term effects of concussions and the importance of timely interventions.
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
- 否
入选标准
- •Adults who are medically diagnosed with a concussion.
- •Adults with a connection to the labor market.
- •Participants must be able to communicate in Danish and be able to independently participate in the intervention.
- •Participants must be able to transport themsleves to and from SuB facility for their treatment sessions.
- •Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score must be at least 20, indicating a significant severity of symptoms following a concussion.
排除标准
- •Persons without medically verified concussion.
- •Person where brain injury was found at symptom onset.
- •Persons with significant cognitive dysfunction.
- •Persons who are unable to understand Danish or with communication disorders that hinder test performance.
- •Persons with terminal illness or other progressive disease.
- •Chronic use of opioids.
- •Significant abuse of alcohol or euphoriants or narcotics or other serious illnesses that may affect test results or ability/possibility of attendance.
结局指标
主要结局
Weekly working hours
时间窗: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Weekly working hours, measured in hours, will be assessed at baseline and after the intervention is completed. Subsequently, working hours will be assessed 1, 2, and 3 years after the intervention is completed. Follow-up will be conducted via telephone calls
次要结局
- European Quality of Life - 5 Dimensions(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Clinical Global Impression Scale (CGI)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Brain Injury Vision Symptom Survey (BIVSS)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- King-Devick (K-D)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Vestibular Ocular Motor Screening (VOMS)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Reading test(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Major Depression Inventory (MDI)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Fatigue Severity Scale - 7 item (FSS-7)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Visual Analogue Scale for Smerte (VAS)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Questionnaire about sound sensitivity and tinnitus(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Depression, Anxiety and Stress Scale (DASS42)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Harvard Trauma Questionnaire (HTQ)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Generalized Anxiety Disorder Scale - 7 item (GAD-7)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Work Role Functioning Questionnaire v. 2.0 (WRFQ 2.0).(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
- Behavioural Rating Inventory of Executive Function - Adults (BRIEF-A)(Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention)
研究者
Rune Skovgaard Rasmussen
MSc, Ph.D., associate professor
University Hospital, Gentofte, Copenhagen