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.

Details

Title
Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial
Author
Potter, Claire 1 ; Leggat, Fiona 2 ; Lowe, Rachel 1 ; Pallmann, Philip 1 ; Riaz, Muhammad 1 ; Barlow, Christy 1 ; Edwards, Adrian 3 ; Siriwardena, Aloysius Niroshan 4 ; Sevdalis, Nick 5 ; Sewell, Bernadette 6 ; McRae, Jackie 2 ; Fish, Jessica 7 ; de Sousa de Abreu, Maria Ines 8 ; Jones, Fiona 9 ; Busse, Monica 1   VIAFID ORCID Logo 

1  Cardiff University, Centre for Trials Research, School of Medicine, Cardiff, UK (GRID:grid.5600.3) (ISNI:0000 0001 0807 5670) 
2  St George’s University of London, Population Health Research Institute, London, England, UK (GRID:grid.264200.2) (ISNI:0000 0000 8546 682X); Kingston University, London, Faculty of Health, Social Care and Education, London, England, UK (GRID:grid.15538.3a) (ISNI:0000 0001 0536 3773) 
3  Cardiff University, PRIME Centre Wales, Division of Population Medicine, School of Medicine, Cardiff, UK (GRID:grid.5600.3) (ISNI:0000 0001 0807 5670); Wales COVID-19 Evidence Centre, Cardiff, UK (GRID:grid.5600.3) 
4  University of Lincoln, Community and Health Research Unit, Lincoln, UK (GRID:grid.36511.30) (ISNI:0000 0004 0420 4262) 
5  King’s College London, Centre for Implementation Science, London, UK (GRID:grid.13097.3c) (ISNI:0000 0001 2322 6764) 
6  Swansea University, Swansea Centre for Health Economics, Swansea, UK (GRID:grid.4827.9) (ISNI:0000 0001 0658 8800) 
7  St George’s University Hospitals NHS Foundation Trust and Mental Health & Wellbeing, School of Health and Wellbeing, University of Glasgow, Department of Clinical Neuropsychology & Clinical Health Psychology, Glasgow, UK (GRID:grid.8756.c) (ISNI:0000 0001 2193 314X) 
8  East Sussex Healthcare NHS Trust Crisis Response Service, St Leonards-on-Sea, UK (GRID:grid.439656.b) (ISNI:0000 0004 0466 4605) 
9  St George’s University of London, Population Health Research Institute, London, England, UK (GRID:grid.264200.2) (ISNI:0000 0000 8546 682X); Kingston University, London, Faculty of Health, Social Care and Education, London, England, UK (GRID:grid.15538.3a) (ISNI:0000 0001 0536 3773); Bridges Self-Management, London, England, UK (GRID:grid.15538.3a) 
Pages
75
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07090-w
ProQuest document ID
2771506518
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.