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Completed

NCT Number: NCT04422873

The Impact of COVID-19 on Dialysis Users

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Sport, Health and Exercise Science

Portsmouth, Outside the United States Or Canada, PO1 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Willing and able to undertake the interview process
  • Able to give informed consent

Exclusion criteria

  • Age < 18 years
  • Does not provide written informed consent
  • Any neurological/psychiatric diagnoses
  • Lack of fluency in English
  • Individuals who have commenced RRT within three months of the study start date

Treatment and study plan

Primary outcomes

  1. Qualitative assessment of the effect of COVID-19 restrictions on patients' well-being, quality of life and physical activity and sedentary behaviours

    Time frame: Day 1

    Participants will be asked during a qualitative interview about the effect of COVID-19 restrictions on their; well-being, quality of life and physical activity and sedentary behaviours

Secondary outcomes

  1. Thematic analysis of qualitative interview exploring patients' experiences of telemedicine during the COVID-19 restrictions in the UK

    Time frame: Day 1

    Participants will be asked during a qualitative interview about their perceptions and experiences of telemedicine

Sponsors and collaborators

Lead sponsor

University of Portsmouth

Other

Collaborators

  • Portsmouth Hospitals NHS Trust
  • University of Reading

Registry information

Official study title

The Impact of Coronavirus (COVID-19) Restrictions on Wellbeing, Quality of Life and Physical Activity in People With End-stage Renal Disease, Currently Dialysing In-centre Versus at Home in the UK and Their Experience of Telemedicine

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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