Hammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark.
Department of Clinical Medicine, AU, Aarhus, Denmark.
Trials. 2022 Jul 29;23(1):613. doi: 10.1186/s13063-022-06572-7.
Persistent post-concussion symptoms (PCS) are associated with prolonged disability, reduced health-related quality of life and reduced workability. At present, no strong evidence for treatments for people with persistent PCS exists. Our research group developed a novel intervention, "Get going After concussIoN (GAIN)", that incorporates multiple evidence-based strategies including prescribed exercise, cognitive behavioural therapy, and gradual return to activity advice. In a previous randomised trial, GAIN provided in a hospital setting was effective in reducing symptoms in 15-30-year-olds with PCS 2-6 months post-injury. In the current study, we describe the protocol for a trial designed to test the effectiveness of GAIN in a larger municipality setting. Additionally, we test the intervention within a broader age group and evaluate a broader range of outcomes. The primary hypothesis is that participants allocated to enhanced usual care plus GAIN report a higher reduction in PCS 3 months post-intervention compared to participants allocated to enhanced usual care only.
The study is a stepped-wedge cluster-randomised trial with five clusters. The 8-week interdisciplinary GAIN program will be rolled out to clusters in 3-month intervals. Power calculation yield at least 180 participants to be enrolled. Primary outcome is mean change in PCS measured by the Rivermead Post-Concussion Symptoms Questionnaire from enrolment to 3 months after end of treatment. Secondary outcomes include participation in and satisfaction with everyday activities, labour market attachment and other behavioural measures. Self-reported outcomes are measured at baseline, by end of treatment and at 3, 6, and 18 months after end of treatment. Registry-based outcomes are measured up to 36 months after concussion.
The trial will provide important information concerning the effectiveness of the GAIN intervention in a municipality setting. Furthermore, it will provide knowledge of possible barriers and facilitators that may be relevant for future implementation of GAIN in different settings.
The current GAIN trial is registered in ClinicalTrials.gov (study identifier: NCT04798885 ) on 20 October 2020.
持续性脑震荡后症状（PCS）与长期残疾、降低健康相关生活质量和降低工作能力有关。目前，对于持续性 PCS 患者，尚无强有力的治疗证据。我们的研究小组开发了一种新的干预措施，即“脑震荡后恢复（GAIN）”，该措施结合了多种基于证据的策略，包括规定的运动、认知行为疗法和逐渐恢复活动建议。在之前的一项随机试验中，在医院环境中提供 GAIN 对受伤后 2-6 个月的 15-30 岁 PCS 患者的症状有效。在当前研究中，我们描述了一项试验方案，旨在测试 GAIN 在更大的市政环境中的有效性。此外，我们在更广泛的年龄组中测试该干预措施，并评估更广泛的结果。主要假设是，与仅接受增强常规护理的参与者相比，分配到增强常规护理加 GAIN 的参与者在干预后 3 个月报告 PCS 降低幅度更高。
该研究是一项五组的阶梯式楔形集群随机试验。8 周的跨学科 GAIN 计划将以每 3 个月为间隔推广到各集群。通过计算功效，至少有 180 名参与者将被招募。主要结局是通过 Rivermead 脑震荡后症状问卷测量的 PCS 平均变化，从入组到治疗结束后 3 个月。次要结局包括参与和对日常活动的满意度、劳动力市场联系和其他行为措施。自我报告的结局在基线、治疗结束时以及治疗结束后 3、6 和 18 个月进行测量。基于登记的结局在脑震荡后 36 个月进行测量。
该试验将提供关于 GAIN 干预在市政环境中有效性的重要信息。此外，它将提供有关可能的障碍和促进因素的知识，这些障碍和促进因素可能对未来在不同环境中实施 GAIN 具有重要意义。
目前的 GAIN 试验于 2020 年 10 月 20 日在 ClinicalTrials.gov 注册（研究标识符：NCT04798885）。
