The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Return to work
研究概览
简要总结
A considerable number of patients with mild and moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places.
The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.
详细描述
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
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
- Double (Participant, Outcomes Assessor)
盲法说明
Particpant are blinded to Group allocation, and all assessments are blinded to Group allocation.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reside in Oslo and Akershus counties in Norway
- •mild-to-moderate TBI (Glasgow Coma scale score 10-15 at injury site). Confirmation of diagnosis of mild TBI will be done through documenting that acute symptoms adhere to the American Congress of Rehabilitation Medicine's (ACRM) definition of mild TBI.
- •loss of consciousness <24 hours
- •posttraumatic amnesia (PTA) <7 days
- •employed in a minimum 50% position at the time of injury
- •sick listed at the 50% or higher level due to post-concussive symptoms 2 months post-injury
排除标准
- •history of severe psychiatric or neurological illness
- •active substance abuse
- •inability to speak and read Norwegian
结局指标
主要结局
Return to work
时间窗: 18 months post injury
The effect of the intervention on return to work rates throughout the follow-up period
Work stability
时间窗: 18 months post injury
The effect of the intervention on work stability rates throughout the follow-up period
次要结局
- Euro-Qol - 5D (EQ-5D)(18 months)
- Quality of life after brain injury (Qolibri)(18 months)
- Rivermead post-concussion questionnaire(18 months)
研究者
Nada Andelic
MD, PhD
Oslo University Hospital
