End Stage Renal DiseaseNCT04422873
The Impact of COVID-19 on Dialysis Users
An observational study of End Stage Renal Disease and Sars-CoV2, run by University of Portsmouth at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Sars-CoV2
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with advanced ESRD (eGFR < 15 mL/min/1.73m2) will be recruited into this study. Persons falling into two distinct categories will be approached: 1. ESRD on ICHD 2. ESRD on HHD
Who may be able to join
- Aged 18 years or older
- Willing and able to undertake the interview process
- Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Health and Exercise Science
Portsmouth, Outside the United States Or Canada, PO1 2ER
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- End Stage Renal Disease, Sars-CoV2
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| in-centre | Currently dialysing in-centre | |
| home | Currently dialysing at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of the effect of COVID-19 restrictions on patients' well-being, quality of life and physical activity and sedentary behaviours
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
Measured: Day 1
Secondary outcomes (1)
Thematic analysis of qualitative interview exploring patients' experiences of telemedicine during the COVID-19 restrictions in the UK
Participants will be asked during a qualitative interview about their perceptions and experiences of telemedicine
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Jun 2020
- Primary completion15 Jul 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University of Reading
- Responsible party
- Principal investigator, Dr Zoe Saynor, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422873
- Sponsor's protocol ID
- 004
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Transcripts will not be uploaded to repositories
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04422873
- Acronym / sponsor ID
- 004
- Conditions
- End Stage Renal Disease, Sars-CoV2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University of Reading
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in-centre | – | –Currently dialysing in-centre |
| home | – | –Currently dialysing at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with advanced ESRD (eGFR < 15 mL/min/1.73m2) will be recruited into this study. Persons falling into two distinct categories will be approached: 1. ESRD on ICHD 2. ESRD on HHD
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Willing and able to undertake the interview process
- Able to give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Thematic analysis of qualitative interview exploring patients' experiences of telemedicine during the COVID-19 restrictions in the UK
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No. Transcripts will not be uploaded to repositories
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Sars-CoV2, run by University of Portsmouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.