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

Potter, C. et al. (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, 75. (doi: 10.1186/s13063-023-07090-w) (PMID:36726167) (PMCID:PMC9890432)

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).

• Item Type: Articles
• Additional Information: This research was funded by the National Institute for Health and Care Research (NIHR) [Under the Long COVID in non-hospitalised individuals Call: COV-LT2-0009]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The study is sponsored by Kingston University and supported by the Centre for Trials Research, Cardiff University, PRIME Centre Wales and the Wales COVID-19 Evidence Centre. The Centre for Trials Research receive infrastructure funding from Health and Care Research Wales and Cancer UK. PRIME Centre Wales and the Wales COVID-19 Evidence Centre receive infrastructure funding from Health and Care Research Wales. FJ and NS’s research is supported by the NIHR Applied Research Collaboration (ARC) South London at King's College Hospital NHS Foundation Trust. NS is a member of King’s Improvement Science, which offers co-funding to the NIHR ARC South London and is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), and Guy’s and St Thomas’ Foundation.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Fish, Dr Jessica
• Authors: Potter, C., Leggat, F., Lowe, R., Pallmann, P., Riaz, M., Barlow, C., Edwards, A., Siriwardena, A. N., Sevdalis, N., Sewell, B., McRae, J., Fish, J., de Sousa de Abreu, M. I., Jones, F., and Busse, M.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Mental Health and Wellbeing
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2023 The Authors
• First Published: First published in Trials 24:75
• Publisher Policy: Reproduced under a Creative Commons licence