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Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial

OBJECTIVES: The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people...

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Autores principales: McGregor, Gordon, Sandhu, Harbinder, Bruce, Julie, Sheehan, Bartholomew, McWilliams, David, Yeung, Joyce, Jones, Christina, Lara, Beatriz, Smith, Jessica, Ji, Chen, Fairbrother, Elaine, Ennis, Stuart, Heine, Peter, Alleyne, Sharisse, Guck, Jonathan, Padfield, Emma, Potter, Rachel, Mason, James, Lall, Ranjit, Seers, Kate, Underwood, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785779/
https://www.ncbi.nlm.nih.gov/pubmed/33407804
http://dx.doi.org/10.1186/s13063-020-04978-9
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author McGregor, Gordon
Sandhu, Harbinder
Bruce, Julie
Sheehan, Bartholomew
McWilliams, David
Yeung, Joyce
Jones, Christina
Lara, Beatriz
Smith, Jessica
Ji, Chen
Fairbrother, Elaine
Ennis, Stuart
Heine, Peter
Alleyne, Sharisse
Guck, Jonathan
Padfield, Emma
Potter, Rachel
Mason, James
Lall, Ranjit
Seers, Kate
Underwood, Martin
author_facet McGregor, Gordon
Sandhu, Harbinder
Bruce, Julie
Sheehan, Bartholomew
McWilliams, David
Yeung, Joyce
Jones, Christina
Lara, Beatriz
Smith, Jessica
Ji, Chen
Fairbrother, Elaine
Ennis, Stuart
Heine, Peter
Alleyne, Sharisse
Guck, Jonathan
Padfield, Emma
Potter, Rachel
Mason, James
Lall, Ranjit
Seers, Kate
Underwood, Martin
author_sort McGregor, Gordon
collection PubMed
description OBJECTIVES: The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. TRIAL DESIGN: Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. PARTICIPANTS: Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. Exclusion criteria: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. INTERVENTION AND COMPARATOR: Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). MAIN OUTCOMES: The primary outcome is health-related quality of life (HRQoL) – PROMIS® 29+2 Profile v2.1 (PROPr) – measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. RANDOMISATION: Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. BLINDING (MASKING): To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. TRIAL STATUS: Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. TRIAL REGISTRATION: ISRCTN:11466448, 23rd November 2020 FULL PROTOCOL: The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.
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spelling pubmed-77857792021-01-06 Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial McGregor, Gordon Sandhu, Harbinder Bruce, Julie Sheehan, Bartholomew McWilliams, David Yeung, Joyce Jones, Christina Lara, Beatriz Smith, Jessica Ji, Chen Fairbrother, Elaine Ennis, Stuart Heine, Peter Alleyne, Sharisse Guck, Jonathan Padfield, Emma Potter, Rachel Mason, James Lall, Ranjit Seers, Kate Underwood, Martin Trials Letter OBJECTIVES: The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. TRIAL DESIGN: Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. PARTICIPANTS: Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. Exclusion criteria: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. INTERVENTION AND COMPARATOR: Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). MAIN OUTCOMES: The primary outcome is health-related quality of life (HRQoL) – PROMIS® 29+2 Profile v2.1 (PROPr) – measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. RANDOMISATION: Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. BLINDING (MASKING): To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. TRIAL STATUS: Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. TRIAL REGISTRATION: ISRCTN:11466448, 23rd November 2020 FULL PROTOCOL: The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. BioMed Central 2021-01-06 /pmc/articles/PMC7785779/ /pubmed/33407804 http://dx.doi.org/10.1186/s13063-020-04978-9 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Letter
McGregor, Gordon
Sandhu, Harbinder
Bruce, Julie
Sheehan, Bartholomew
McWilliams, David
Yeung, Joyce
Jones, Christina
Lara, Beatriz
Smith, Jessica
Ji, Chen
Fairbrother, Elaine
Ennis, Stuart
Heine, Peter
Alleyne, Sharisse
Guck, Jonathan
Padfield, Emma
Potter, Rachel
Mason, James
Lall, Ranjit
Seers, Kate
Underwood, Martin
Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial
title Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial
title_full Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial
title_fullStr Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial
title_full_unstemmed Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial
title_short Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial
title_sort rehabilitation exercise and psychological support after covid-19 infection’ (regain): a structured summary of a study protocol for a randomised controlled trial
topic Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785779/
https://www.ncbi.nlm.nih.gov/pubmed/33407804
http://dx.doi.org/10.1186/s13063-020-04978-9
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