Condition category
Infections and Infestations
Date applied
20/11/2020
Date assigned
23/11/2020
Last edited
13/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People recovering from COVID-19 can feel weak, breathless and tired. Some people are also worried and frightened. For most people, these problems will get better on their own, but for some people, they may continue for a long time after leaving hospital. A rehabilitation programme may help. For people who are still struggling months after being ill with COVID-19, the aim of this study is to find out which of two treatments is better for helping people recover: a single online session of exercise advice and support or an 8-week online exercise and support programme

Who can participate?
People who have been treated in hospital for COVID-19 who were discharged more than 3 months ago and still have health problems due to COVID-19

What does the study involve?
After a questionnaire has been completed, participants will be assigned by chance (randomised) to one of the two treatments. Participants assigned to a single online session of exercise advice and support will have a 30-minute call with a REGAIN exercise specialist during which they will be given information on how to safely increase activity and exercise at home. They will also be directed to websites where more information and support can be found and will be able to ask questions about recovery from COVID-19.
Participants assigned to an 8-week online exercise and support programme will have a 60-minute call with a REGAIN exercise specialist during which they will be given an activity and exercise plan to follow at home. Participants will also be directed to websites where more information and support can be found and will be able to ask questions about recovery from COVID-19. They will also join a live online exercise (1 hour per week) and support (1 hour per week) group for 8 weeks, and will be able to access on-demand physical activity and exercise sessions as required.

What are the possible benefits and risks of participating?
Although this study may not offer any direct benefit, the findings may help people recovering from COVID-19 in the future. The researchers do not anticipate any serious risk to participants. There is always a very small chance that exercise can make people feel unwell. Exercise may cause tiredness, breathlessness and sore muscles, but this should get a bit easier over time. All exercise will be advised and monitored by specialist staff. Sometimes people can find the support sessions upsetting. Fully trained specialist staff will provide appropriate support and assistance if needed.

Where is the study run from?
University Hospitals Coventry and Warwickshire NHS Trust (UK)

When is the study starting and how long is it expected to run for?
September 2020 to August 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Ms Sharisse Alleyne
REGAIN@warwick.ac.uk

Trial website

https://warwick.ac.uk/regain/

Contact information

Type

Scientific

Primary contact

Ms Sharisse Alleyne

ORCID ID

Contact details

REGAIN Trial Manager
Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
regain@warwick.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46819, IRAS 288362

Study information

Scientific title

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN): a multi-centre randomized controlled trial

Acronym

REGAIN

Study hypothesis

An intensive, online, supervised, group, home-based rehabilitation programme will be clinically and cost-effective, compared to best practice usual care, for people discharged from hospital (>3/12) after COVID-19 infection

Ethics approval

Approved 06/11/2020, East of England – Cambridge South REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048065; cambridgesouth.rec@hra.nhs.uk), REC ref: 20/EE/0235

Study design

Randomized; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

https://warwick.ac.uk/fac/sci/med/research/ctu/trials/regain/regain_pis.pdf

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

A multi-centre RCT testing the clinical and cost-effectiveness of an intensive, online, supervised, group, home-based rehabilitation programme that supports long-term physical and mental health recovery (REGAIN) vs. best-practice usual care for people discharged from hospital (>3/12) after COVID-19 infection.

Patients will be identified via two routes:

1. Participant Identification Centres
Clinical care teams at UHCW NHS Trust and each PIC site (NHS hospital trust) will screen hospital discharge data and identify potential participants for contact by mail. The sites will send potential participants an infographic flyer and invitation letter which will direct potential participants to the study website to find out more information and to register their interest.

2. Self Referral
The study will be promoted through local/national media/social media, relevant charities and on the study website. People suffering from ongoing COVID-19-related symptoms following hospital discharge will be able to self-refer and to register their interest via the study website.

Further to baseline assessment, a total of 535 participants will be randomised to the REGAIN intervention or best practice usual care.

The REGAIN Intervention: Eight-week, online, supervised, home-based, exercise rehabilitation programme with behavioural, motivational and mental health support.

Best-practice usual care consisting of a single online session of advice and support.

Outcomes will be assessed at baseline pre-randomisation, 3, 6 and 12 months (post-randomisation). The primary outcome will be HRQoL measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 3 months post-randomisation. Data will be collected directly from trial participants using online data collection.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Health-related quality of life (HRQoL) measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 3 months post-randomisation

Secondary outcome measures

Measured at 3, 6 and 12 months post-randomisation:
1. Health-related quality of life (HRQoL) measured using PROPr
2. Dyspnoea measured using PROMIS dyspnoea severity Short Form
3. Cognitive function measured using PROMIS Neuro-QoL Short Form v2.0 - Cognitive Function
4. Health utility measured using Euroqol EQ-5D-5L
5. Physical activity participation measured using the International Physical Activity Questionnaire (IPAQ short-form)
6. PTSD symptom severity measured using the Impacts of Events Scale-Revised (IES-R)
7. Depressive and anxiety symptoms measured using the Hospital Anxiety and Depression Scale (HADS)
8. Work status measured using time lost from work (paid/unpaid) and patient-borne health costs
9. Health and social care resource use measured using participant self-report and NHS records
10. Death measured using GP data

Overall trial start date

01/09/2020

Overall trial end date

31/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥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 ability/support to use email, text message, internet video, including webcam and audio
5. Ability to provide informed consent
6. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 535; UK Sample Size: 535

Participant exclusion criteria

1. Exercise contraindicated
2. Severe mental health problems preventing engagement
3. Previous randomisation in the present trial
4. Patient already engaging in, or planning to engage in a conflicting NHS delivered rehabilitation programme in the next 12 weeks
5. A member of the same household has previously been randomised in the present trial

Recruitment start date

30/11/2020

Recruitment end date

30/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Coventry and Warwickshire NHS Trust
Walsgrave General Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS Trust

Sponsor details

c/o Becky Haley
Research & Development
4th Floor Rotunda
ADA40007
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 966198
becky.haley@uhcw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhcw.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR132046

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be published in a peer-reviewed journal. The researchers will publish papers in open-access journals describing the development and refinement of the REGAIN intervention, and the study protocol, as per recommended guidance for transparent reporting, the Consolidated Standards of Reporting Trials (CONSORT) guidelines (https://www.consort-statement.org), the NIHR standard terms, and Warwick SOP 22: Publication & Dissemination. The Warwick Clinical Trials Unit will publish the results of the trial on their website when these are available. Publication of the initial trial results, including the primary outcome, will take place as soon as possible (scheduled for January 2022).

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 protocol in https://doi.org/10.1186/s13063-020-04978-9 (added 07/01/2021)

Publication citations

Additional files

Editorial Notes

07/01/2021: Publication reference added. 27/11/2020: Participant information sheet link updated. 20/11/2020: Trial's existence confirmed by the NIHR.