Sedsel Kristine Stage Pedersen, Mille Møller Thastum, Lene Odgaard, Erhard Trillingsgaard Næss-Schmidt, Carsten Bøcker Pedersen, Charlotte Nygaard, Hanne Pallesen, Noah D Silverberg, Iris Brunner
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The objective of this study is to evaluate the efficacy of the novel intervention GAIN Lite added to enhanced usual care (EUC) for adults with mild-to-moderate PPCS compared to EUC only.</p><p><strong>Methods: </strong>An open-label, parallel-group, two-arm randomised controlled superiority trial (RCT) with 1:1 allocation ratio. Potential participants will be identified through the hospital's Business Intelligence portal of the Central Denmark Region or referred by general practitioners within 2-4 months post-concussion. Participants with mild-to-moderate PPCS will be randomly assigned to either (1) EUC or (2) GAIN Lite added to EUC. GAIN Lite is characterised as a complex intervention and has been developed, feasibility-tested and process evaluated before effect evaluation in the RCT. GAIN Lite contains an initial remote interview, self-administrated e-learning videos and voluntary remote counselling with an allocated occupational- or physiotherapist. Sixty-six participants will be recruited to each group. Primary outcomes are mean changes in PPCS and limitations in daily life from baseline to 24 weeks after baseline.</p><p><strong>Discussion: </strong>GAIN Lite is a low-intensity intervention for adults with mild-to-moderate PPCS. Offering a remote intervention may improve access to rehabilitation and prevent chronification for individuals with mild-to-moderate PPCS. Moreover, GAIN Lite will facilitate access to healthcare, especially for those with transportation barriers. Overall, GAIN Lite may provide an accessible, flexible and convenient way to receive treatment based on sound theories and previous evidence of effective interventions for adults with mild-to-moderate PPCS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05233475. 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引用次数: 0
摘要
背景：全世界每年有超过 3,000 万至 5,000 万人受到轻微脑外伤（即脑震荡）的影响。在丹麦，脑震荡的发病率估计每年约为 20,000 例。虽然脑震荡通常会在几周内完全缓解，但多达三分之一的患者会在三个月后出现持续性脑震荡后症状（PPCS）。有效治疗策略的证据很少。本研究的目的是评估在增强型常规护理（EUC）中加入新型干预GAIN Lite对轻度至中度PPCS成人患者的疗效，并与仅在常规护理中加入GAIN Lite进行比较：方法：这是一项开放标签、平行分组、双臂随机对照优效试验（RCT），分配比例为 1:1。潜在参与者将通过丹麦中部大区医院的商业智能门户网站确定，或由脑震荡后2-4个月内的全科医生转介。轻度至中度 PPCS 患者将被随机分配到 (1) EUC 或 (2) GAIN Lite。GAIN Lite 是一种复杂的干预措施，在进行 RCT 效果评估之前，已对其进行了开发、可行性测试和过程评估。GAIN Lite 包含初始远程访谈、自我管理的电子学习视频以及由指定的职业或物理治疗师提供的自愿远程咨询。每组将招募 66 名参与者。主要结果是PPCS和日常生活限制从基线到基线后24周的平均变化：讨论：GAIN Lite 是一种针对轻度至中度 PPCS 成人的低强度干预措施。提供远程干预可改善轻度至中度 PPCS 患者的康复机会，防止慢性化。此外，GAIN Lite 还能方便患者，尤其是交通不便的患者获得医疗服务。总之，GAIN Lite 可为轻度至中度 PPCS 成人患者提供一种基于可靠理论和以往有效干预证据的可获得、灵活和方便的治疗方式：试验注册：ClinicalTrials.gov NCT05233475。注册日期：2022 年 2 月 10 日。
A remotely delivered intervention targeting adults with persisting mild-to-moderate post-concussion symptoms (GAIN Lite): a study protocol for a parallel group randomised trial.
Background: Worldwide, mild traumatic brain injury, synonymous with concussion, affects more than 30-50 million each year. The incidence of concussion in Denmark is estimated to be about 20,000 yearly. Although complete resolution normally occurs within a few weeks, up to a third develop persistent post-concussion symptoms (PPCS) beyond 3 months. Evidence for effective treatment strategies is scarce. The objective of this study is to evaluate the efficacy of the novel intervention GAIN Lite added to enhanced usual care (EUC) for adults with mild-to-moderate PPCS compared to EUC only.
Methods: An open-label, parallel-group, two-arm randomised controlled superiority trial (RCT) with 1:1 allocation ratio. Potential participants will be identified through the hospital's Business Intelligence portal of the Central Denmark Region or referred by general practitioners within 2-4 months post-concussion. Participants with mild-to-moderate PPCS will be randomly assigned to either (1) EUC or (2) GAIN Lite added to EUC. GAIN Lite is characterised as a complex intervention and has been developed, feasibility-tested and process evaluated before effect evaluation in the RCT. GAIN Lite contains an initial remote interview, self-administrated e-learning videos and voluntary remote counselling with an allocated occupational- or physiotherapist. Sixty-six participants will be recruited to each group. Primary outcomes are mean changes in PPCS and limitations in daily life from baseline to 24 weeks after baseline.
Discussion: GAIN Lite is a low-intensity intervention for adults with mild-to-moderate PPCS. Offering a remote intervention may improve access to rehabilitation and prevent chronification for individuals with mild-to-moderate PPCS. Moreover, GAIN Lite will facilitate access to healthcare, especially for those with transportation barriers. Overall, GAIN Lite may provide an accessible, flexible and convenient way to receive treatment based on sound theories and previous evidence of effective interventions for adults with mild-to-moderate PPCS.
Trial registration: ClinicalTrials.gov NCT05233475. Registered on February 10, 2022.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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