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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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(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
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 | ||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine |
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| 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: |
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| 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: |
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