Leggat Fiona, Torrens-Burton Anna, Sewell Bernadette, Sevdalis Nick, Busse Monica, Domeney Anne, Parsons Judith, Abreu Maria Ines de Sousa de, Jones Fiona
Population Health Research Institute, School of Health and Medical Sciences, City St George's, University of London, London, UK.
PRIME Centre Wales, Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.
Health Expect. 2025 Jun;28(3):e70270. doi: 10.1111/hex.70270.
BACKGROUND: The development and evaluation of rehabilitation interventions designed to support people with Long Covid (LC) remains an important ongoing priority. Many people with LC experience episodic, debilitating symptoms that can reduce their ability to engage in all areas of activity. The Long CovId personalised Self-managemenT support co-design and EvaluatioN (LISTEN) trial co-designed and evaluated a personalised self-management support intervention to build confidence and support people to live better with LC. This paper describes the context, implementation, mechanisms of impact and impacts from the LISTEN intervention, in comparison with usual LC services accessed within the National Health Service (NHS). METHODS: A mixed methods process evaluation was nested within the LISTEN pragmatic, multi-site, randomised controlled trial. Data were collected from sites in England and Wales between September 2022 and January 2024. Observations and focus groups with healthcare practitioners (HCPs) delivering the intervention were conducted to assess fidelity. Standardised implementation measures, focussed on intervention feasibility, acceptability and appropriateness, were gathered from HCPs and intervention participants. Semi-structured interviews were undertaken with a subset of participants across both trial arms. Data were analysed independently using descriptive statistics, or reflexive thematic analyses, and subsequently integrated, drawing upon the Consolidated Framework for Implementation Research v2. FINDINGS: Thirty-six HCPs participated in the process evaluation, and 197 intervention participants completed standardised implementation measures. Across both trial arms, 49 participants took part in semi-structured interviews. Six integrated themes were constructed from all data sources describing and illustrating links between the context, implementation, mechanisms of impact and impacts: 'Delivery during uncertainty and ambiguity', 'Diversity and consistency of usual care', 'Drivers for self-care and the impact of self-generated expertise', 'Appropriate if unexpected support', 'Personalisation at the core of success' and 'A spectrum of change'. CONCLUSION: The LISTEN intervention is an appropriate, feasible intervention for participants and HCPs. The intervention can be delivered to a high level of fidelity following training and with ongoing HCP support. Access, receipt and perceptions of NHS LC services were variable. Personalised, relational interventions, such as LISTEN, can foster favourable impacts on confidence, knowledge and activity and are acceptable and strongly recommended within LC rehabilitation services. PATIENT OR PUBLIC CONTRIBUTION: The study was supported by a patient and public involvement and engagement (PPIE) group from project conception to study end. Using their lived expertise, seven people with LC supported accessible recruitment (e.g., materials), data collection (e.g., topic guides), data interpretation (e.g., theme construction and reviewing findings) and dissemination activities (e.g., online webinars). TRIAL REGISTRATION: ISRCTN36407216, registered 27/01/2022.
背景:旨在支持长新冠患者的康复干预措施的开发和评估仍然是当前一项重要的优先工作。许多长新冠患者会经历间歇性的、使人衰弱的症状,这可能会降低他们参与各个活动领域的能力。长新冠个性化自我管理支持共同设计与评估(LISTEN)试验共同设计并评估了一种个性化自我管理支持干预措施,以增强信心并帮助人们更好地应对长新冠。本文描述了LISTEN干预措施的背景、实施情况、影响机制以及与英国国家医疗服务体系(NHS)内常规长新冠服务相比所产生的影响。 方法:一项混合方法过程评估嵌套在LISTEN实用、多中心、随机对照试验中。2022年9月至2024年1月期间从英格兰和威尔士的研究点收集数据。对实施干预的医疗保健从业者(HCPs)进行观察和焦点小组讨论,以评估干预的保真度。从HCPs和干预参与者那里收集了侧重于干预可行性、可接受性和适宜性的标准化实施措施。对两个试验组的一部分参与者进行了半结构化访谈。使用描述性统计或反思性主题分析对数据进行独立分析,随后根据实施研究综合框架第2版进行整合。 结果:36名HCPs参与了过程评估,197名干预参与者完成了标准化实施措施。在两个试验组中,49名参与者参加了半结构化访谈。从所有数据源构建了六个综合主题,描述并说明了背景、实施、影响机制和影响之间的联系:“在不确定性和模糊性中实施”、“常规护理的多样性和一致性”、“自我护理的驱动因素以及自我产生的专业知识的影响”、“意外支持时的适宜性”、“成功的核心是个性化”以及“一系列变化”。 结论:LISTEN干预措施对参与者和HCPs来说是一种适宜、可行的干预措施。经过培训并在HCPs的持续支持下,该干预措施能够以较高的保真度实施。NHS长新冠服务的可及性、接受情况和认知存在差异。像LISTEN这样的个性化、关系型干预措施可以对信心、知识和活动产生积极影响,在长新冠康复服务中是可接受的,强烈推荐使用。 患者或公众参与:该研究从项目构思到研究结束均得到了患者和公众参与及介入(PPIE)小组的支持。七名长新冠患者利用他们的实际经验,支持了可及性招募(例如材料)、数据收集(例如主题指南)、数据解读(例如主题构建和审查结果)以及传播活动(例如在线网络研讨会)。 试验注册:ISRCTN36407216,于2022年1月27日注册。
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