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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

Fiona Leggat Orcid Logo, Anna Torrens‐Burton, Berni Sewell, Nick Sevdalis, Monica Busse, Anne Domeney, Judith Parsons, Maria Ines de Sousa de Abreu, Fiona Jones

Health Expectations, Volume: 28, Issue: 3, Start page: e70270

Swansea University Author: Berni Sewell

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DOI (Published version): 10.1111/hex.70270

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...

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Published in: Health Expectations
ISSN: 1369-6513 1369-7625
Published: Wiley 2025
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The Long CovId personalised Self&#x2010;managemenT support co&#x2010;design and EvaluatioN (LISTEN) trial co&#x2010;designed and evaluated a personalised self&#x2010;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&#x2010;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&#x2010;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&#x2010;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&#x2010;structured interviews. Six integrated themes were constructed from all data sources describing and illustrating links between the context, implementation, mechanisms of impact and impacts: &#x2018;Delivery during uncertainty and ambiguity&#x2019;, &#x2018;Diversity and consistency of usual care&#x2019;, &#x2018;Drivers for self&#x2010;care and the impact of self&#x2010;generated expertise&#x2019;, &#x2018;Appropriate if unexpected support&#x2019;, &#x2018;Personalisation at the core of success&#x2019; and &#x2018;A spectrum of change&#x2019;. 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><type>Journal Article</type><journal>Health Expectations</journal><volume>28</volume><journalNumber>3</journalNumber><paginationStart>e70270</paginationStart><paginationEnd/><publisher>Wiley</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1369-6513</issnPrint><issnElectronic>1369-7625</issnElectronic><keywords>fidelity, implementation, intervention, Long Covid, personalised, process evaluation, self-management</keywords><publishedDay>1</publishedDay><publishedMonth>6</publishedMonth><publishedYear>2025</publishedYear><publishedDate>2025-06-01</publishedDate><doi>10.1111/hex.70270</doi><url/><notes/><college>COLLEGE NANME</college><CollegeCode>COLLEGE CODE</CollegeCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>This study is independent research funded by the National Institute for Health and Care Research (NIHR) [Long Covid Personalised Self-managemenT support co-design and EvaluatioN (LISTEN), COV-LT2-0009]. Authors are chief investigators or co-investigators on various current research grants from the UK NIHR. The Centre for Trials Research receives infrastructure funding from Health and Care Research Wales. PRIME Centre Wales and the former Wales Covid-19 Evidence Centre (now Health and Care Research Wales Evidence Centre) receive infrastructure funding from Health and Care Research Wales. 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spelling 2025-05-08T12:29:23.0680878 v2 69451 2025-05-08 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 f6a4af2cfa4275d2a8ebba292fa14421 Berni Sewell Berni Sewell true false 2025-05-08 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. Journal Article Health Expectations 28 3 e70270 Wiley 1369-6513 1369-7625 fidelity, implementation, intervention, Long Covid, personalised, process evaluation, self-management 1 6 2025 2025-06-01 10.1111/hex.70270 COLLEGE NANME COLLEGE CODE Swansea University Another institution paid the OA fee This study is independent research funded by the National Institute for Health and Care Research (NIHR) [Long Covid Personalised Self-managemenT support co-design and EvaluatioN (LISTEN), COV-LT2-0009]. Authors are chief investigators or co-investigators on various current research grants from the UK NIHR. The Centre for Trials Research receives infrastructure funding from Health and Care Research Wales. PRIME Centre Wales and the former Wales Covid-19 Evidence Centre (now Health and Care Research Wales Evidence Centre) receive infrastructure funding from Health and Care Research Wales. Up until March 2024, F.J.'s research was supported by the NIHR Applied Research Collaboration South London at King's College Hospital NHS Foundation Trust. 2025-05-08T12:29:23.0680878 2025-05-08T12:21:08.6455844 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Fiona Leggat 0000-0002-1452-3895 1 Anna Torrens‐Burton 2 Berni Sewell 3 Nick Sevdalis 4 Monica Busse 5 Anne Domeney 6 Judith Parsons 7 Maria Ines de Sousa de Abreu 8 Fiona Jones 9 69451__34201__92922380d1644e828ac6a3ad819a8bc2.pdf hex.70270.pdf 2025-05-08T12:21:08.6161892 Output 4195922 application/pdf Version of Record true © 2025 The Author(s). This is an open access article under the terms of the Creative Commons Attribution (CC BY) License. true eng http://creativecommons.org/licenses/by/4.0/
title 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
spellingShingle 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
Berni Sewell
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv f6a4af2cfa4275d2a8ebba292fa14421
author_id_fullname_str_mv f6a4af2cfa4275d2a8ebba292fa14421_***_Berni Sewell
author Berni Sewell
author2 Fiona Leggat
Anna Torrens‐Burton
Berni Sewell
Nick Sevdalis
Monica Busse
Anne Domeney
Judith Parsons
Maria Ines de Sousa de Abreu
Fiona Jones
format Journal article
container_title Health Expectations
container_volume 28
container_issue 3
container_start_page e70270
publishDate 2025
institution Swansea University
issn 1369-6513
1369-7625
doi_str_mv 10.1111/hex.70270
publisher Wiley
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
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description 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.
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