Hoeffding Louise K, Nielsen Maria Haahr, Rasmussen Morten A, Norup Anne, Arango-Lasprilla Juan Carlos, Kjær Ulrikka K, Burgdorf Kristoffer Sølvsten, Quas Kirsten Jensen, Schow Trine
Research and development, Brain Injury Center BOMI, Maglegaardsvej 15, 4000, Roskilde, Denmark.
Institute of Biological Psychiatry, Mental Health Centre Sct. Hans, Copenhagen University Hospital, Roskilde, Denmark.
Trials. 2017 Aug 10;18(1):371. doi: 10.1186/s13063-017-2115-0.
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. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care).
This study is an interventional, two-arm, six-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 six- to nine-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 six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed.
This study consists of a comprehensive multidiciplinary VR intervention involving several 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. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers.
ClinicalTrials.gov, NCT03086031 . Registered on 21 March 2017.
获得性脑损伤（ABI）是一种复杂的损伤，常伴有广泛的认知、身体、情感和行为障碍。由于这些障碍，职业康复（VR）是一项具有挑战性的任务，但至关重要，因为大约75%的ABI患者处于工作年龄。因此，迫切需要针对ABI患者的标准化、临床有效且具有成本效益的VR方法。因此，本研究的目的是评估与传统VR（常规护理）相比，针对ABI患者的个体化手动VR的效果。
本研究是一项干预性、双臂、为期六个月随访的整群随机对照试验，涉及丹麦西兰岛地区和首都地区的四个直辖市。总共84名均匀分布在四个直辖市的ABI患者将被纳入研究。患者将以1:1的比例随机分配到由专门的脑损伤中心提供的VR干预组或由直辖市提供的传统VR组（常规护理）。为期六至九个月的干预将包括个体和团体治疗以及一个包括支持性就业的工作安置计划。此外，干预将包括一个家庭干预计划，并随后为一名家庭照顾者提供支持。主要结局是六个月随访时工作或学习率的提高。此外，将对干预进行预算影响分析以及可能的成本效用分析。
本研究包括一项全面的多学科VR干预，涉及多个方面，如直辖市、专业康复团队和患者自己的家庭照顾者。如果与传统VR相比，这种干预被证明是成功的，它将为基于手动的个体化整体方法在ABI后重返工作岗位提供证据。此外，该研究将为临床医生、研究人员和政策制定者提供有关VR干预可行性和临床有效性的新知识。
ClinicalTrials.gov，NCT03086031。于2017年3月21日注册。
