Personalisation at the Core of Success: Process Evaluation of the LISTEN Randomised Controlled Trial Evaluating a Personalised Self-Management Support Intervention for People Living With Long Covid

IF 3.2 3区医学 Q2 HEALTH CARE SCIENCES & SERVICES

Health Expectations Pub Date : 2025-05-05 DOI:10.1111/hex.70270

Fiona Leggat, Anna Torrens-Burton, Bernadette Sewell, Nick Sevdalis, Monica Busse, Anne Domeney, Judith Parsons, Maria Ines de Sousa de Abreu, Fiona Jones

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引用次数: 0

Abstract

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.

Abstract Image

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个性化是成功的核心：LISTEN随机对照试验的过程评估，该试验评估了长期感染者个性化自我管理支持干预措施

开发和评估旨在支持长期Covid （LC）患者的康复干预措施仍然是一个重要的优先事项。许多患有LC的人会经历间歇性的衰弱症状，这些症状会降低他们参与所有领域活动的能力。Long CovId个性化自我管理支持共同设计和评估（LISTEN）试验共同设计和评估了个性化自我管理支持干预措施，以建立信心并支持LC患者更好地生活。本文描述了LISTEN干预的背景、实施、影响机制和影响，并与国家卫生服务体系（NHS）内访问的常规LC服务进行了比较。方法在LISTEN实用、多站点、随机对照试验中嵌套混合方法工艺评价。这些数据是在2022年9月至2024年1月期间从英格兰和威尔士收集的。对提供干预措施的医疗保健从业人员（HCPs）进行观察和焦点小组，以评估保真度。从医护人员和干预参与者中收集标准化的实施措施，重点是干预的可行性、可接受性和适当性。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专题分析对数据进行独立分析，然后根据《实施研究综合框架2》对数据进行整合。结果36名医护人员参与了过程评价，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，描述和说明了背景、实施、影响机制和影响之间的联系：“在不确定性和模糊性期间的交付”、“常规护理的多样性和一致性”、“自我护理的驱动因素和自我产生的专业知识的影响”、“适当的意外支持”、“成功核心的个性化”和“变化的范围”。结论LISTEN干预对参与者和医护人员是一种合适、可行的干预方法。在培训和持续的HCP支持下，干预措施可以达到高水平的保真度。获取、接收和感知NHS LC服务是可变的。个性化的关系干预措施，如LISTEN，可以对信心、知识和活动产生有利影响，在LC康复服务中是可接受的，并强烈推荐。患者或公众的贡献本研究从项目构思到研究结束都得到了患者和公众参与和参与（PPIE）小组的支持。利用他们的生活专业知识，七名LC人员支持无障碍招聘（例如，材料），数据收集（例如，主题指南），数据解释（例如，主题构建和审查结果）和传播活动（例如，在线网络研讨会）。试验注册号为ISRCTN36407216，注册日期为27/01/2022。

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来源期刊

Health Expectations 医学-公共卫生、环境卫生与职业卫生

CiteScore

5.20

自引率

9.40%

发文量

251

审稿时长

>12 weeks

期刊介绍： Health Expectations promotes critical thinking and informed debate about all aspects of patient and public involvement and engagement (PPIE) in health and social care, health policy and health services research including: • Person-centred care and quality improvement • Patients'' participation in decisions about disease prevention and management • Public perceptions of health services • Citizen involvement in health care policy making and priority-setting • Methods for monitoring and evaluating participation • Empowerment and consumerism • Patients'' role in safety and quality • Patient and public role in health services research • Co-production (researchers working with patients and the public) of research, health care and policy Health Expectations is a quarterly, peer-reviewed journal publishing original research, review articles and critical commentaries. It includes papers which clarify concepts, develop theories, and critically analyse and evaluate specific policies and practices. The Journal provides an inter-disciplinary and international forum in which researchers (including PPIE researchers) from a range of backgrounds and expertise can present their work to other researchers, policy-makers, health care professionals, managers, patients and consumer advocates.