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Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) : a multi-centre randomised controlled trial
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(2024) Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) : a multi-centre randomised controlled trial. British Medical Journal, 384 . e076506. doi:10.1136/bmj-2023-076506 ISSN 0959-8146. (In Press)
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Official URL: https://doi.org/10.1136/bmj-2023-076506
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.
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.
Item Type: | Journal Article | ||||||||
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Alternative Title: | Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial | ||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
Journal or Publication Title: | British Medical Journal | ||||||||
Publisher: | BMJ Group | ||||||||
ISSN: | 0959-8146 | ||||||||
Official Date: | 2024 | ||||||||
Dates: |
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Volume: | 384 | ||||||||
Article Number: | e076506 | ||||||||
DOI: | 10.1136/bmj-2023-076506 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | In Press | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 12 December 2023 | ||||||||
Date of first compliant Open Access: | 9 May 2024 | ||||||||
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