A Randomised Controlled Trial of a Manual-Based Vocational Rehabilitation Program for Patients With Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 主要终点
- Increased work/study rate at 6-month follow-up
研究概览
简要总结
An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed.
This study is an interventional, two-arm, 6-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The 6-9 month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at 6-month follow-up. Moreover, a budget impact analysis and possibly a cost utility analysis of the intervention will be performed The program is one of the first to include a comprehensive and target VR intervention including multiple parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI.
The first hypothesis of the study is that more participants allocated to the VR intervention group will have a significant higher employment/study rate (measured in hours) at 6-month follow-up when compared to participants receiving the conventional VR program provided by the municipalities (control group). The second hypothesis is that health-related quality of life (HRQoL) and disability among the participants as well as the HRQoL and caregiver burden among the caregivers are significantly improved at the end of the VR intervention and at 6-month follow-up when compared to the conventional VR program. Finally, a budget impact and possibly a cost utility analysis will be performed.
详细描述
An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, most patients with ABI find it challenging to remain in or return to work/education post-injury even though approximately 75% of these patients are of working age.
Vocational rehabilitation (VR) is often a prolonged process leading to high cost to the health care system and society. Barriers to VR success include the severity of the ABI, age at injury, income and education pre-injury, but also challenges directly related to the workplace. Often, the employer has little or no knowledge about the consequences of an ABI and, in addition, lack of communication regarding the challenges and needs in relation to work-related tasks influence the VR.
Even though returning to work has proven important for long term ABI survival and increased levels of quality of life standardized research-based VR programs targeting patents with ABI have been lacking. It has previously been shown that support from specialized VR teams help patients with ABI returning to work post-injury but only few studies have examined the long term effect.
Previous VR interventions have been performed similarly to all patients even though ABI is a broad diagnostic category with various degrees and characteristics. Thus, VR interventions that are tailored to each patient might be proven more efficient and effective in enhancing returning to work.
This study is an interventional, two-arm, 6-month follow-up, cluster randomized controlled trail including 84 participants with an ABI allocated randomly (allocation ratio 1:1) to the VR intervention and control group that consists of a conventional VR program (usual care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the study, it is not possible to blind neither the participants nor the rehabilitation team, but they will be asked not to disclose any details about the allocation, or the content of the VR. The two independent research assistants will be trained to administer the assessments and will be blinded to the allocation when entering data into the database. The researchers and the statistician performing the data analysis are blind to the treatment arm in which the participants are allocated. The rehabilitation team and the research assistants will only be involved in the data collection and will therefore not participate in the data analyses.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffers from an acquired brain injury
- •acquired the brain injury within the last 3 to 24 months
- •currently unemployed, but employed/enrolled at an education prior to the injury
- •motivated to participate in vocational rehabilitation
- •able to participate in group sessions
- •able to understand and speak Danish
- •have at least two Family caregivers willing to participate in the study
排除标准
- •have any other somatic or psychiatric illnesses before the acquired brain injury that make it impossible to complete the intervention
- •suffer from substance abuse or severe aphasia
- •have a progressive brain injury
- •are pregnant,
- •have a mini mental state examination score <23.
研究组 & 干预措施
Program-based vocational rehabilitation
Combined intervention with a neuropsychological, social and community intervention followed by a vocational rehabilitation programme with a total length of 6-9 months.
干预措施: Program -based vocational rehabilitation intervention (Behavioral)
Conventional vocational rehabilitation(controls)
Individuals allocated to the control group will receive the conventional VR program provided by the four municipalities over the same period of time. Thus, the participants in the control group will receive VR support by the local municipal authority that may vary in content and intensity. As for the intervention group, each individual in the control group will select a family caregiver that will go through the same questionnaires as the caregivers in the VR intervention group regarding health-related quality of life and functional level. Furthermore, the case manager at the municipalities will oblige to (1) hand out the baseline questionnaires to the participants and their family caregivers, (2) complete a questionnaire about each participants at the beginning, the end of the study, and again at 6-month of follow-up.
干预措施: Conventional vocational rehabilitation (controls) (Behavioral)
结局指标
主要结局
Increased work/study rate at 6-month follow-up
时间窗: Measurement assessed at baseline, and after 4 months, 9 months, and 15 months.
The information will be recorded from the involved municipalities own registers and by interviews.
次要结局
- Selv-perceived burden to others(Measurement assessed at baseline, and after 4,9 and 15 months.)
- Physical function(Measurement assessed at baseline, and after 4 and 15 months.)
- Anxiety and depression(Measurement assessed at baseline, and after 9 and 15 months.)
- Daily activity(Measurement assessed at baseline, and after 9 and 15 months.)
- Proficiency on functional task and functional status(Measurement assessed at baseline, and after 4 months, 9 months, and 15 months.)
- Executive functions(Measurement assessed at baseline, and after 4 and 15 months.)
- Perceived Stress(Measurement assessed at baseline, and after 4, 9 and 15 months.)
- Health related quality of life(Measurement assessed at baseline, and after 4, 9 months and 15 months.)
- Fatigue(Measurement assessed at baseline, and after 4, 9 and 15 months.)
- Problem Solving Inventory(Measurement assessed at baseline, and after 4 and 15 months.)