长新冠患者个性化自我管理干预的效果和成本效益：LISTEN 随机对照试验方案。
Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial.
机构信息
Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, Wales, UK.
Population Health Research Institute, St George's University of London, London, England, UK.
出版信息
Trials. 2023 Feb 1;24(1):75. doi: 10.1186/s13063-023-07090-w.
BACKGROUND
Individuals living with long COVID experience multiple, interacting and fluctuating symptoms which can have a dramatic impact on daily living. The aim of the Long Covid Personalised Self-managemenT support EvaluatioN (LISTEN) trial is to evaluate effects of the LISTEN co-designed self-management support intervention for non-hospitalised people living with long COVID on participation in routine activities, social participation, emotional well-being, quality of life, fatigue, and self-efficacy. Cost-effectiveness will also be evaluated, and a detailed process evaluation carried out to understand how LISTEN is implemented.
METHODS
The study is a pragmatic randomised effectiveness and cost-effectiveness trial in which a total of 558 non-hospitalised people with long COVID will be randomised to either the LISTEN intervention or usual care. Recruitment strategies have been developed with input from the LISTEN Patient and Public Involvement and Engagement (PPIE) advisory group and a social enterprise, Diversity and Ability, to ensure inclusivity. Eligible participants can self-refer into the trial via a website or be referred by long COVID services. All participants complete a range of self-reported outcome measures, online, at baseline, 6 weeks, and 3 months post randomisation (the trial primary end point). Those randomised to the LISTEN intervention are offered up to six one-to-one sessions with LISTEN-trained intervention practitioners and given a co-designed digital resource and paper-based book. A detailed process evaluation will be conducted alongside the trial to inform implementation approaches should the LISTEN intervention be found effective and cost-effective.
DISCUSSION
The LISTEN trial is evaluating a co-designed, personalised self-management support intervention (the LISTEN intervention) for non-hospitalised people living with long COVID. The design has incorporated extensive strategies to minimise participant burden and maximise access. Whilst the duration of follow-up is limited, all participants are approached to consent for long-term follow-up (subject to additional funding being secured).
TRIAL REGISTRATION
LISTEN ISRCTN36407216. Registered on 27/01/2022.
背景
长期新冠患者会经历多种相互作用且波动的症状，这些症状会对日常生活产生巨大影响。“长期新冠个性化自我管理支持评估（LISTEN）”试验旨在评估 LISTEN 共同设计的自我管理支持干预措施对非住院长期新冠患者日常活动参与、社会参与、情绪健康、生活质量、疲劳和自我效能的影响。还将评估成本效益，并进行详细的过程评估，以了解 LISTEN 的实施情况。
方法
该研究是一项实用的随机有效性和成本效益试验，共有 558 名非住院的长期新冠患者将被随机分配到 LISTEN 干预组或常规护理组。通过 LISTEN 患者和公众参与和参与（PPIE）咨询小组以及社会企业 Diversity and Ability 的投入制定了招募策略，以确保包容性。合格的参与者可以通过网站自行选择参与试验，也可以通过长期新冠服务转介。所有参与者都通过在线方式在基线、6 周和 3 个月随机分组后完成一系列自我报告的结果测量（试验的主要终点）。随机分配到 LISTEN 干预组的参与者将获得最多六次与 LISTEN 培训的干预从业者的一对一会议，并获得共同设计的数字资源和纸质书籍。将在试验期间进行详细的过程评估，以告知实施方法，如果 LISTEN 干预被发现有效且具有成本效益。
讨论
LISTEN 试验正在评估一种共同设计的、个性化的自我管理支持干预措施（LISTEN 干预），用于非住院的长期新冠患者。该设计纳入了广泛的策略，以尽量减少参与者的负担并最大限度地提高参与度。虽然随访时间有限，但所有参与者都被邀请同意进行长期随访（取决于额外资金的保障）。
试验注册
LISTEN ISRCTN36407216。于 2022 年 1 月 27 日注册。
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