Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04422873 |
| Other study ID # |
004 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2020 |
| Est. completion date |
March 15, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Portsmouth |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To understand the impact of COVID-19 restrictions on the wellbeing, quality of life and
physical activity of people with end-stage renal disease, currently dialysing in-centre
versus at home in the UK and their experience of telemedicine.
Description:
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered
coronavirus. Most people infected with the COVID-19 virus will experience mild-to-moderate
respiratory illness, however, some older people and those with underlying medical problems
are more likely to develop serious illness.
One group who are particularly vulnerable at this time is people with chronic kidney disease
(CKD). Of this group, particularly at risk are those at the more severe end of the disease
spectrum [end stage renal disease (ESRD], who rely on renal replacement therapy (RRT), in the
form of dialysis, to do the job of the kidneys. The investigators currently have a programme
of clinical research investigating the impact of home versus in-hospital RRT, using both
qualitative (IRAS: 264200) and quantitative approaches (IRAS: 254251). A key focus of this
work is to explore determinants of wellbeing, function and overall quality of life that are
linked to dialysis modality.
On Monday 23rd March, the UK Government imposed significant restrictions with regards to
human movement, for at least three weeks (recently extended to at least 6 weeks) to try and
reduce the risk of the COVID-19 disease spreading within the UK. These included: only
shopping for basic necessities; one form of exercise a day, such as a walk, run or cycle;
travel for specific medical needs; those travelling to and from work, where this is
absolutely necessary and it cannot be done from home.
This is an interesting time, since it is usually observed that people who dialysis at home
(i.e. home haemodialysis) typically have more freedom to go out, as they do not have the
thrice weekly commute to a renal clinic, which is a burden itself, to then undergo ~4 hours
of dialysis at the unit. People who dialyse at home are now isolating entirely and in charge
of their own treatment, resulting in very little contact with others. The Wessex Kidney
Centre has, however, implemented remote clinics and has been trialling an application to
assess patient-reported outcome measures (PROMs) as part of its ongoing programme of
research. Those dialysing in-centre however, continue to have contact with medical staff in
person thrice weekly and are forced to break isolation and go into a clinical setting.
Through the proposed study, the research team will capture patients' experience during this
unique and unprecedented time, in order to guide practice moving forwards and identify
potential areas for intervention. More specifically, the purpose of this study is to
understand the impact of COVID-19 restrictions on the wellbeing, quality of life and physical
activity of people with end-stage renal disease, currently dialysing in-centre versus at home
in the UK and their experience of telemedicine. This information may be used to help us
better support individuals in the future and investigate the feasibility of telemedicine in
routine clinical practice.
