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      Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial

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          Abstract

          Background

          Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge.

          Methods

          Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions.

          Results

          The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos.

          Conclusions

          The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID.

          Trial registration

          International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.

          Plain English summary

          Long-COVID has many debilitating symptoms, such as breathlessness, muscle weakness and fatigue, which significantly affect peoples’ physical and mental health and quality of life. Rehabilitation programmes can help people improve their quality of life in other medical conditions with similar symptoms. We developed a programme of physical and mental health rehabilitation, delivered online, specifically to support people with ongoing long-COVID symptoms more than three months after hospital discharge. The programme was developed by people with long-COVID along with clinicians and researchers. The programme described in this article is now being tested in a large research trial to see if it can help people with long-COVID.

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          Most cited references20

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          The behaviour change wheel: A new method for characterising and designing behaviour change interventions

          Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.
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            A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

            The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.
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              Pulmonary rehabilitation for chronic obstructive pulmonary disease.

              Widespread application of pulmonary rehabilitation (also known as respiratory rehabilitation) in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function (health-related quality of life, functional and maximal exercise capacity) attributable to the programmes. This review updates the review reported in 2006.
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                Author and article information

                Contributors
                Role: InvestigationRole: MethodologyRole: Project AdministrationRole: ResourcesRole: ValidationRole: VisualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Role: Data CurationRole: InvestigationRole: MethodologyRole: Project AdministrationRole: ResourcesRole: ValidationRole: VisualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: Project AdministrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: MethodologyRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Data CurationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: ResourcesRole: ValidationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: Writing – Review & Editing
                Role: ConceptualizationRole: Data CurationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: Project AdministrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Data CurationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: Project AdministrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: InvestigationRole: MethodologyRole: Project AdministrationRole: SupervisionRole: ValidationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Journal
                NIHR Open Res
                NIHR Open Res
                NIHR Open Research
                F1000 Research Limited (London, UK )
                2633-4402
                14 July 2023
                2023
                : 3
                : 10
                Affiliations
                [1 ]Clinical Trials Unit, University of Warwick, Coventry, UK
                [2 ]Cardiopulmonary Rehabilitation, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK
                [3 ]The Oxford Psychological Medicine Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
                [4 ]Centre for Care Excellence, Coventry University, Coventry, UK
                [5 ]ICUsteps Peer Support Charity, ICUsteps Peer Support Charity, London, UK
                [6 ]School of Psychology, Deakin University, Melbourne, Australia
                [7 ]Health Sciences, University of Warwick, Coventry, UK
                [8 ]Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK
                [1 ]Ludwig Boltzmann Institute for Digital Health and Prevention, Ludwig Boltzmann Gesellschaft, Salzburg, Austria
                [1 ]Institute for Health and Care Improvement, York St John University, York, UK
                [1 ]Ludwig Boltzmann Institute for Digital Health and Prevention, Ludwig Boltzmann Gesellschaft, Salzburg, Austria
                [1 ]Institute for Health and Care Improvement, York St John University, York, UK
                Author notes

                Competing interests: JB, MU, GM, HS, BS, JY, DW are chief or co-investigators on multiple research grants funded by NIHR and other funding bodies. KS previously sat on the NIHR HS&RD funding board for 8 years. SE and GM are directors of Atrium Health Ltd, a provider of rehabilitation services for the National Health Service. HS is director of Health Psychology Services Ltd, providing psychological services for a range of health-related conditions. MU is chief investigator or co-investigator grants from Arthritis Research UK and is a co-investigator on grants funded by the Australian NHMRC and Norwegian MRC. He was an NIHR Senior Investigator until March 2021. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund, related to return to work initiatives. MU and JB receive some salary support from University Hospitals Coventry and Warwickshire NHS Trust. MU is a co-investigator on two current and one completed NIHR funded studies that are, of have had, additional support from Stryker Ltd. Until March 2020 he was an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he received a fee. JB is a co-investigator on one NIHR funded study that receives support from Stryker Ltd.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: none

                Competing interests: No competing interests were disclosed.

                Competing interests: none

                Author information
                https://orcid.org/0000-0003-2950-4758
                https://orcid.org/0000-0002-9086-2557
                https://orcid.org/0000-0002-8462-7999
                https://orcid.org/0000-0001-7921-552X
                https://orcid.org/0000-0001-8963-9107
                Article
                10.3310/nihropenres.13371.2
                10593321
                37881468
                514d5007-15f7-466d-b7cb-e05d54bf8720
                Copyright: © 2023 Ennis S et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 June 2023
                Funding
                Funded by: National Institute for Health and Care Research
                Award ID: NIHR132046
                This research was funded by the National Institute for Health Research Health Technology Assessment Programme: COVID-19 Recovery & Learning (NIHR132046).
                The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Articles

                rehabilitation,long-covid,physical activity,online support,intervention development

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