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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

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McGregor, Gordon, Sandhu, Harbinder, Bruce, Julie, Sheehan, Bartholomew, McWilliams, David, Yeung, Joyce, Jones, Christina, Lara, Beatriz, Smith, Jessica L., Ji, Chen et al.
(2021) Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN) : a structured summary of a study protocol for a randomised controlled trial. Trials, 22 (1). 8. doi:10.1186/s13063-020-04978-9

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Official URL: http://dx.doi.org/10.1186/s13063-020-04978-9

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Abstract

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.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
Divisions: Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): COVID-19 (Disease) , COVID-19 (Disease) -- Treatment , COVID-19 (Disease) -- Exercise therapy, COVID-19 (Disease) -- Patients -- Exercise therapy, COVID-19 (Disease) -- Patients -- Psychological aspects, Clinical trials
Journal or Publication Title: Trials
Publisher: Biomed Central
ISSN: 1745-6215
Official Date: 6 January 2021
Dates:
DateEvent
6 January 2021Published
15 December 2020Accepted
Date of first compliant deposit: 27 January 2021
Volume: 22
Number: 1
Article Number: 8
DOI: 10.1186/s13063-020-04978-9
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
NIHR132046[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272

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