Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial

Trials

Study Protocol

Nick Sevdalis¹  Philip Pallmann²  Monica Busse²  Rachel Lowe²  Claire Potter²  Muhammad Riaz²  Christy Barlow²  Aloysius Niroshan Siriwardena³  Jessica Fish⁴  Maria Ines de Sousa de Abreu⁵  Adrian Edwards⁶  Jackie McRae⁷  Fiona Leggat⁷  Fiona Jones⁸  Bernadette Sewell⁹ 

[1] Centre for Implementation Science, King’s College London, London, UK;Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, Wales, UK;Community and Health Research Unit, University of Lincoln, Lincoln, UK;Department of Clinical Neuropsychology & Clinical Health Psychology, St George’s University Hospitals NHS Foundation Trust and Mental Health & Wellbeing, School of Health and Wellbeing, University of Glasgow, Glasgow, UK;East Sussex Healthcare NHS Trust Crisis Response Service, St. Annes House, St Leonards-on-Sea, East Sussex, UK;PRIME Centre Wales, Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, Wales, UK;Wales COVID-19 Evidence Centre, Cardiff, Wales, UK;Population Health Research Institute, St George’s University of London, London, England, UK;Faculty of Health, Social Care and Education, Kingston University, London, London, England, UK;Population Health Research Institute, St George’s University of London, London, England, UK;Faculty of Health, Social Care and Education, Kingston University, London, London, England, UK;Bridges Self-Management, London, England, UK;Swansea Centre for Health Economics, Swansea University, Swansea, UK;

关键词: Long COVID;    Self-management;    Rehabilitation;    Participation;    Process evaluation;    Implementation;   

DOI  :  10.1186/s13063-023-07090-w

 received in 2022-11-21, accepted in 2023-01-10,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundIndividuals 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.MethodsThe 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.DiscussionThe 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 registrationLISTEN ISRCTN36407216. Registered on 27/01/2022.

【 授权许可】

CC BY   
© The Author(s) 2023

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