慢性创伤性脑损伤的需求和治疗选择:社区干预的可行性试验

I. Borgen, M. Løvstad, C. Røe, M. Forslund, S. Hauger, S. Sigurdardottir, L. Winter, Ingerid Kleffelgård
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引用次数: 2

摘要

创伤性脑损伤(TBI)后可能出现终身变化。目前对创伤性脑损伤慢性期的相关治疗方案缺乏研究。在美国开发了一种创新的、以家庭为基础的干预计划,并证明对患有创伤性脑损伤的美国退伍军人有效。然而,跨文化适用性和有效性尚不清楚。本研究的目的是在未来确定的随机对照试验(RCT)之前评估在挪威人群中的可行性。在挪威首都奥斯陆招募了6名患有严重脑外伤的参与者并接受了干预。主要可行性目标是评估(i)招募和筛选程序,(ii)基线和随访评估,(iii)干预交付,(iv)可接受性,以及(v)主要和次要结果测量的顺序。没有发现干预的不良影响。发现基线评估时间过长。干预实施可行,可接受性高。对结果措施进行了审查,并认为有必要进行修订。在严重创伤性脑损伤人群中,个性化定制、目标集中的干预方案被认为是可行的,初步结果似乎很有希望。可行性试验对纳入标准、基线评估和结果测量进行了重要修订,这些修订在RCT研究开始前就已被采用。该随机对照试验研究于2018年6月开始招募。
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Needs and treatment options in chronic traumatic brain injury: A feasibility trial of a community-based intervention
Abstract Lifelong changes may be expected after sustaining a traumatic brain injury (TBI). Research on relevant treatment options in the chronic phase of TBI is lacking. An innovative, home-based intervention program was developed in the US and showed to be effective among US veterans who had sustained a TBI. However, the cross-cultural applicability and effectiveness are unknown. The aim of the present study is to evaluate the feasibility in a Norwegian population before a future definitive randomized controlled trial (RCT). Six participants with severe TBI in metropolitan Oslo, Norway, were recruited and received the intervention. Primary feasibility objectives were to evaluate (i) recruitment and screening procedures, (ii) baseline and follow-up assessments, (iii) intervention delivery, (iv) acceptability, and (v) order of primary and secondary outcome measures. No adverse effects of the intervention were uncovered. Baseline assessment was found to be too long. Intervention delivery was feasible and acceptability high. Outcome measures were reviewed and amendments were deemed necessary. An individually tailored, goal-focused intervention program was deemed feasible in a population of severe TBI and the preliminary results seem promising. The feasibility trial led to important amendments to inclusion criteria, baseline assessment and outcome measures that were adapted before the RCT study commenced. The RCT-study started recruitment in June 2018.
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