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

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.

Co-designing personalised self-management support for people living with long Covid: The LISTEN protocol.

BACKGROUND: Long Covid is recognised as a complex condition characterised by multiple, interacting and fluctuating symptoms which impact everyday life in diverse ways. The extent of symptom clusters and variability supports interventions that can accommodate heterogeneity, such as personalised self-management support. This approach is also advocated by people living with long Covid and guidelines published by the UK's National Institute for Health and Care Excellence. Long Covid Personalised Self-managemenT support co-design and EvaluatioN (LISTEN) is one of 15 research projects funded by the UK's National Institute of Health Research long Covid research programme. LISTEN aims to work with people living with or recovered from long Covid to co-design self-management resources, and a training programme for rehabilitation practitioners to deliver personalised support. The intervention will focus on people not hospitalised for Covid. The protocol presented here details the co-design of the LISTEN intervention which, on completion, will be evaluated in a randomised controlled trial. METHODS: The study will utilise an Accelerated Experience-Based Co-Design approach, and involve 30 people from England and Wales with lived experience of long Covid, and 15 rehabilitation practitioners living with, or supporting people with, long Covid. Through online meetings, participants will share their stories of long Covid, their challenges and strategies to live better with or recover from long Covid, their priorities for self-management resources and the practitioner training andcreate, review and refine these resources and the training. Throughout, LISTEN will draw upon the UK standards of public involvement in research. DISCUSSION: If effective and cost-effective, the intervention will be available across the UK's National Health Service. The first of its kind, this study could make a difference to the lives of people with long Covid. To ensure impact, we have developed strategies to involve people from diverse backgrounds and mitigate potential barriers to involvement.

What is the feasibility and patient acceptability of a digital system for arm and hand rehabilitation after stroke? A mixed-methods, single-arm feasibility study of the 'OnTrack' intervention for hospital and home use.

OBJECTIVES: Arm weakness is common after stroke; repetitive activity is critical for recovery but people struggle with knowing what to do, volume, and monitoring progress. We studied the feasibility and acceptability of OnTrack, a digital intervention supporting arm and hand rehabilitation in acute and home settings. DESIGN: A mixed-method, single-arm study evaluating the feasibility of OnTrack for hospital and home use. An independent process evaluation assessed the intervention's fidelity, dose and reach. Amendments to the protocol were necessary after COVID-19. SETTING: Acute stroke services and home settings in North West London. PARTICIPANTS: 12 adults with a stroke diagnosis <6 months previously (first or recurrent) requiring arm rehabilitation in hospital and/or home. INTERVENTION: 12 weeks using the OnTrack system comprising arm tracking and coaching support for self-management. PRIMARY AND SECONDARY OUTCOME MEASURES: Recruitment, retention and completion rates; compliance and adherence to the intervention; reasons for study decline/withdrawal.Intervention fidelity and acceptability, evaluated through an independent process evaluation.Patient measures including activity baseline, healthcare activation, arm function and impairment collected at baseline, week 7 and week 14 of participation to assess suitability for a randomised controlled trial (RCT). RESULTS: 181 individuals screened, 37 met eligibility criteria, 24 recruited (65%); of these, 15 (63%) were recruited before COVID-19, and 9 (37%) during. 12 completed the intervention (50%). Despite COVID-19 disruptions, recruitment, retention and completion were in line with prestudy expectations and acceptable for a definitive trial. Participants felt the study requirements were acceptable and the intervention usable. Fidelity of delivery was acceptable according to predetermined fidelity markers. Outcome measures collected helped determine sample size estimates and primary outcomes for an RCT. CONCLUSIONS: The intervention was found to be usable and acceptable by participants; study feasibility objectives were met and demonstrated that a definitive RCT would be viable and acceptable. TRIAL REGISTRATION NUMBER: NCT03944486.

A Protocol to Understand the Implementation and Experiences of an Online Community-Based Performance Arts Programme Through and Beyond the COVID-19 Pandemic, Brain Waves

Introduction Individuals living with acquired brain injury experience numerous psychological, physical, and social challenges. Since the COVID-19 pandemic, many have experienced additional isolation, mental health issues and have had limited access to social and physical activities otherwise available in the community. Materials and Methods Brain Waves is a 12-week online performance arts programme developed during the COVID-19 pandemic, for people with acquired brain injury (ABI). The research component of Brain Waves is a qualitative study, using Interpretative Phenomenological Analysis (IPA) and ethnographic methods (Observations and Interviews). The study will recruit two distinct populations: individuals living with acquired brain injury (including people who have experienced traumatic brain injury and stroke who are participating in the programme) and stakeholders (facilitators, involved in the delivery of Brain Waves). This paper presents the protocol for a project which aims to gain an understanding of the implementation and experiences of creating and participating in an online community-based performance arts programme.

Evaluation of a community-based performance arts programme for people who have experienced stroke in the UK: protocol for the SHAPER-Stroke Odysseys study.

INTRODUCTION: Stroke survivors, once in the community, face challenges with their long-term rehabilitation care and present higher levels of loneliness, depression and anxiety than the rest of the population. A community-based performance arts programme, Stroke Odysseys (SO), has been devised to tackle the challenges of living with stroke in the UK. In this study, we aim to evaluate the implementation, impact and experiences of SO for stroke survivors. METHODS AND ANALYSIS: Scaling-up Health Arts Programmes: Implementation and Effectiveness Research (SHAPER)-SO aims to scale-up SO to 75 participants and 47 stakeholders, while simultaneously evaluating the effectiveness and implementation of the programme. The main research aim is to evaluate the implementation, effectiveness, impact and experiences of a community-based performance arts programme (SO for stroke survivors). This mixed-methods study will evaluate the experience and impact of SO on those participating using mixed methods (interviews, observations and surveys) before and after each stage and carry out non-participant observations during a percentage of the workshops, training and tour. Data will be analysed using quantitative and qualitative approaches. This is a study within the SHAPER programme. ETHICS AND DISSEMINATION: Ethical approval has been granted by the King's College London PNM Research Ethics Panel, REC reference: LRS/DP-20/21-21549. Written informed consent will be sought for participants and stakeholders. The results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04864470.

Delivery of liver services within primary care can improve treatment outcomes in persons experiencing homelessness

BackgroundPersons experiencing homelessness (PEH) often have complex health needs compounded by difficulty accessing healthcare. Liver disease is the third commonest cause for death in PEH after accidents and suicides. Some studies have identified chronic hepatitis C (CHC) in up to 50% of this population. Alcohol disorders are also extremely common.MethodsFrom June 2018, a weekly Hepatology clinic was co-located with a primary care clinic serving a population of 2,500 PEH. Blood borne virus testing, near patient HCV RNA testing, transient elastography and anti-viral drug dispensing for Hepatitis B and C was introduced. All patients with HCV were treated in line with national guidelines.ResultsBetween the period of June 2018 and November 2020, 326 patients were reviewed within the Hepatology clinic. A total of 1,236 appointments were offered with 632 attendances (51.1%).241 patients were referred due to a positive HCV Ab test. 193 were RNA positive (80%), 30 RNA negative (12.4%) and 19 had unknown HCV RNA status. Transient elastography was performed on 138 with 31 having advanced fibrosis.Treatment was initiated on 101/193 HCV RNA positive patients. 93 patients were receiving opiate substitution therapy. 65% had a co-existing mental health diagnosis whilst 24% had a significant alcohol intake, 2% were co-infected with Hepatitis B and C and 3% were co-infected with both Hepatitis C and HIV. The genotypes were 44 G1a;3 G1b;6 G2;34 G3;1 G4 and 13 unknown.There is a high rate of sustained virological response (SVR) being achieved with 61 patients having achieved SVR (82%). 13 patients needed to re-start treatment. 37 have SVR 12 pending. 3 patients have relapsed.Of the remaining 92 known RNA positive patients within the clinic, 40 identified within our service have been treated elsewhere during the peak of the Covid-19 pandemic. 24 SVR blood tests were performed for the patients treated in other locations. 21 patients are approved to start treatment. 9 are awaiting genotyping and transient elastography. 5 are no longer patients of the primary care clinic and attempts have been made to arrange onward referrals to Hepatology services in their new locations and 5 patients have died.ConclusionPersons experiencing homelessness often have difficulty accessing healthcare. By facilitating access to Hepatology services tailored to their needs at a site where they access primary care and receive opiate substitution therapy, favourable SVR rates can be achieved with significant risk reduction.