A randomized trial to assess the effects of physical and mental health rehabilitation for people recovering from COVID-19
| ISRCTN | ISRCTN11466448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11466448 |
| IRAS number | 288362 |
| Secondary identifying numbers | CPMS 46819, IRAS 288362 |
- Submission date
- 20/11/2020
- Registration date
- 23/11/2020
- Last edited
- 01/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 a UK 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 September 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Ms Sharisse Alleyne
REGAIN@warwick.ac.uk
Contact information
Scientific
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 |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://warwick.ac.uk/fac/sci/med/research/ctu/trials/regain/regain_pis.pdf |
| Scientific title | Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN): a multi-centre randomized controlled trial |
| Study 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(s) | 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 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Current intervention as of 13/03/2023: 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 three 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 A REC-approved infographic invitation flyer will be used to promote the study. These infographic invitation flyers will be provided to relevant primary and secondary care NHS COVID clinics for staff to hand out to potential participants. The flyers will also be displayed and available at GP practices and pharmacies. 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. 3. NHS Digital screening At the time of writing, the Secretary of State for Health and Social Care has issued NHS Digital with a Notice under Regulation 3(4) of the Health Service (Control of Patient Information) Regulations 2002 (COPI) to require NHS Digital to share confidential patient information with organisations entitled to process this under COPI for COVID-19 purposes. As such, whilst this COPI Notice is in effect, participants will be identified by NHS Digital for inclusion in the REGAIN study in support of the pandemic response. 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. _____ Previous intervention as of 19/03/2021: 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 A REC-approved infographic invitation flyer will be used to promote the study. These infographic invitation flyers will be provided to relevant primary and secondary care NHS COVID clinics for staff to hand out to potential participants. The flyers will also be displayed and available at GP practices and pharmacies. 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. _____ Previous 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 |
| 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 study start date | 01/09/2020 |
| Overall study end date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 535; UK Sample Size: 535 |
| Total final enrolment | 585 |
| Participant inclusion criteria | Current inclusion criteria as of 19/03/2021: 1. UK resident 2. Aged ≥18 years 3. ≥ 3 months after any UK hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support 4. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems 5. Access to, and ability/support to use, email, text message, internet video, including webcam and audio 6. Ability to provide informed consent 7. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends Previous 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 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 | 30/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development
4th Floor Rotunda, ADA40007
Coventry
CV2 2DX
England
United Kingdom
| Phone | +44 (0)2476 966198 |
|---|---|
| ResearchSponsorship@uhcw.nhs.uk | |
| Website | http://www.uhcw.nhs.uk/ |
"ROR" |
https://ror.org/025n38288 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/01/2021 | 07/01/2021 | Yes | No |
| Other publications | Intervention development v1 | 23/02/2023 | 13/03/2023 | Yes | No |
| Statistical Analysis Plan | version 2.0 | 25/10/2022 | 25/05/2023 | No | No |
| Statistical Analysis Plan | Health economics analysis plan version 2.0 |
15/09/2022 | 25/05/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Intervention development v2 | 14/07/2023 | 26/10/2023 | Yes | No |
| Results article | 07/02/2024 | 09/02/2024 | Yes | No | |
| Results article | Cost-effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-COVID-19 condition after hospitalisation for COVID-19: the REGAIN RCT | 31/10/2024 | 01/11/2024 | Yes | No |
Additional files
- ISRCTN11466448 _SAP (health economics)_v2.0_15Sep2022.pdf
- Health economics analysis plan
- ISRCTN11466448 _SAP_v2.0_25Oct2022.pdf
Editorial Notes
01/11/2024: Publication reference added.
09/02/2024: Publication reference added.
26/10/2023: Publication reference added.
27/06/2023: The intention to publish date was changed from 30/06/2023 to 30/09/2023.
25/05/2023: The following changes have been made:
1. The sponsor contact details have been updated.
2. The SAP and health economics analysis plan (HEAP) have been uploaded.
13/03/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 30/09/2022.
2. The overall trial end date has been changed from 30/06/2023 to 30/09/2023 and the plain English summary updated accordingly.
3. The intervention has been changed.
4. The final enrolment number has been added.
5. Publication reference added.
22/02/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 30/06/2022.
2. The overall trial end date has been changed from 31/08/2022 to 30/06/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/01/2022 to 30/06/2023.
10/06/2021: The recruitment end date has been changed from 30/06/2021 to 31/12/2021.
19/03/2021: The interventions and inclusion criteria were updated.
07/01/2021: Publication reference added.
27/11/2020: Participant information sheet link updated.
20/11/2020: Trial's existence confirmed by the NIHR.
