General and Participant FAQs 

Many survivors of novel coronavirus infections (SARS-Cov and MERS-Cov) had substantial physical, psychological and neurological morbidity for up to 12 months. Similar longer-term consequences of COVID-19 are now apparent.

People recovering from COVID-19 often feel very weak, breathless and tired. A lot of people are also worried and frightened. For most people, these problems will get better on their own. For others, these physical and mental health problems will persist for a long time after leaving hospital.

There is a large population of COVID-19 survivors in the UK with persistently reduced quality of life, even after several months of recovery. Exercise and psychological rehabilitation may help but existing NHS rehabilitation services have insufficient capacity. Alternative delivery models must be tested.

For people who are still struggling months after being ill with COVID-19, we want to find out which of two treatments is better at helping people recover:

• An on-line rehabilitation exercise and psychological support programme

OR 

• A single on-line session of exercise advice and support

We are asking people to take part in the trial if they:

• Were initially admitted to hospital with COVID-19
• Have now been discharged from hospital for over 3 months
• COVID-19 is continuing to have an impact on their physical and/or mental health

We will aim to recruit 535 people in total from across the UK to participate in the REGAIN trial. It is entirely up to the individuals to decide if they want to take part.

First, a member of the study team will contact you to confirm that you are eligible to take part and ask for your consent to take part in the study.

We will then ask you to complete an online questionnaire. You will be asked about the impact COVID-19 has had on your physical and mental health and your quality of life. The questionnaire will take about XX to complete. A member of the study team may contact you if any of your responses are unclear of missing. You will also be asked to complete an online questionnaire again at three months, six months and twelve months.

After you have completed the first online questionnaire you will be assigned by chance to one of the two groups:

1)The single online session of exercise advice and support group

OR  

2)The online rehabilitation exercise class and psychological support programme group

You or the research team will not be able to choose which group you are in. This is decided by a computer at random.

You will be asked to remain in the study for 12 months. With your permission we will contact your GP practice after your involvement in the study to access your medical records, we would like to collect details of your health and any medication and services you have received related to COVID-19 whilst in the study. If you want to take part in the study but don’t want us to check your records, you can indicate this on the consent form.

It is possible that we might want to contact you again after the end of this study to find out how you have been in the long-term.

We do not anticipate any serious risk to you. If you do take part in the exercise classes, you will be carefully advised and monitored by specialist staff. Exercise is likely to cause some tiredness, breathlessness and sore muscles, but this should get a bit easier each time you exercise.

We recommend that you have another person nearby when you first start exercising.

Occasionally, participants may find some of the topics during the mental health support sessions upsetting, our specialist staff are fully trained and will provide appropriate support and assistance should this be needed.

You will need internet access and use of an electronic device that they can make video calls from. This may be a smartphone, laptop, tablet or computer. The device needs to have a camera that faces you, so we can see you during the video call.

We will use video call for your initial assessment and for the exercise classes.

The study team will be available to advise and instruct you on the use of computers, tablets, phones and other devices before each video call and will provide written and online instructions.

PIC Set up

No. This is the model non-commercial agreement (mNCA) and there is no capacity to negotiate.

We are not collecting CVs or GCP for any of the PIC team.

The HRA states: Members of the research team in such studies are expected to be qualified by education, training or experience but should not be required or expected to undertake GCP training.

The REGAIN protocol and trial processes have been designed to ensure the REGAIN trial is conducted in a manner that protects the rights, safety and wellbeing of research participants.

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PIC Screening

Clinical care teams at each PIC will screen hospital discharge data and identify potential participants. You will then send potential participants an invitation letter allocating potential participants a screening ID number. This will direct potential participants to the REGAIN website where they can access the participant information sheet (PIS). The invitation letter and website will instruct potential participants to read the PIS, and if they are interested in taking part in the trial, to access the online database.

The online database will ask potential participants a series of questions to determine their initial eligibility for the trial. If the participant is initially eligible they will be asked to complete an expression of interest form and enter their contact details. A member of the REGAIN team will later get in touch with the patient via telephone to confirm their suitability for the trial and randomise.

If patients are not interested in the trial, the PIS will request that they inform you. The trial database will automatically notify you of any screened patients who are not initially eligible or have been successfully randomised to the trial. This will ensure any subsequent reminder correspondence can be sent only to potential patients who have not yet responded following the initial contact.

Co-enrolment will be reviewed on a case-by-case basis in accordance with NIHR-supported co-enrolment guidelines

We will maintain a list of trials we are co-enrolling with on the trial website.