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

Potter, C; Leggat, F; Lowe, R; Pallmann, P; Riaz, M; Barlow, C; Edwards, A; Siriwardena, AN; Sevdalis, N; Sewell, B; et al. Potter, C; Leggat, F; Lowe, R; Pallmann, P; Riaz, M; Barlow, C; Edwards, A; Siriwardena, AN; Sevdalis, N; Sewell, B; McRae, J; Fish, J; de Sousa de Abreu, MI; Jones, F; Busse, M (2023) Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial. Trials, 24 (1). p. 75. ISSN 1745-6215 https://doi.org/10.1186/s13063-023-07090-w
SGUL Authors: Leggat, Fiona Jane

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Abstract

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.

Item Type: Article
Additional Information: © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords: Implementation, Long COVID, Participation, Process evaluation, Rehabilitation, Self-management, Humans, COVID-19, Post-Acute COVID-19 Syndrome, Cost-Benefit Analysis, Self-Management, Quality of Life, Randomized Controlled Trials as Topic, Humans, Quality of Life, Cost-Benefit Analysis, Randomized Controlled Trials as Topic, Self-Management, COVID-19, Post-Acute COVID-19 Syndrome, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Trials
ISSN: 1745-6215
Language: eng
Dates:
DateEvent
1 February 2023Published
10 January 2023Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
COV-LT2-0009National Institute for Health and Care ResearchUNSPECIFIED
PubMed ID: 36726167
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/115182
Publisher's version: https://doi.org/10.1186/s13063-023-07090-w

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