<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422873</url>
  </required_header>
  <id_info>
    <org_study_id>004</org_study_id>
    <nct_id>NCT04422873</nct_id>
  </id_info>
  <brief_title>The Impact of COVID-19 on Dialysis Users</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Portsmouth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Portsmouth Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Reading</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Portsmouth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To understand the impact of COVID-19 restrictions on the wellbeing, quality of life and&#xD;
      physical activity of people with end-stage renal disease, currently dialysing in-centre&#xD;
      versus at home in the UK and their experience of telemedicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered&#xD;
      coronavirus. Most people infected with the COVID-19 virus will experience mild-to-moderate&#xD;
      respiratory illness, however, some older people and those with underlying medical problems&#xD;
      are more likely to develop serious illness.&#xD;
&#xD;
      One group who are particularly vulnerable at this time is people with chronic kidney disease&#xD;
      (CKD). Of this group, particularly at risk are those at the more severe end of the disease&#xD;
      spectrum [end stage renal disease (ESRD], who rely on renal replacement therapy (RRT), in the&#xD;
      form of dialysis, to do the job of the kidneys. The investigators currently have a programme&#xD;
      of clinical research investigating the impact of home versus in-hospital RRT, using both&#xD;
      qualitative (IRAS: 264200) and quantitative approaches (IRAS: 254251). A key focus of this&#xD;
      work is to explore determinants of wellbeing, function and overall quality of life that are&#xD;
      linked to dialysis modality.&#xD;
&#xD;
      On Monday 23rd March, the UK Government imposed significant restrictions with regards to&#xD;
      human movement, for at least three weeks (recently extended to at least 6 weeks) to try and&#xD;
      reduce the risk of the COVID-19 disease spreading within the UK. These included: only&#xD;
      shopping for basic necessities; one form of exercise a day, such as a walk, run or cycle;&#xD;
      travel for specific medical needs; those travelling to and from work, where this is&#xD;
      absolutely necessary and it cannot be done from home.&#xD;
&#xD;
      This is an interesting time, since it is usually observed that people who dialysis at home&#xD;
      (i.e. home haemodialysis) typically have more freedom to go out, as they do not have the&#xD;
      thrice weekly commute to a renal clinic, which is a burden itself, to then undergo ~4 hours&#xD;
      of dialysis at the unit. People who dialyse at home are now isolating entirely and in charge&#xD;
      of their own treatment, resulting in very little contact with others. The Wessex Kidney&#xD;
      Centre has, however, implemented remote clinics and has been trialling an application to&#xD;
      assess patient-reported outcome measures (PROMs) as part of its ongoing programme of&#xD;
      research. Those dialysing in-centre however, continue to have contact with medical staff in&#xD;
      person thrice weekly and are forced to break isolation and go into a clinical setting.&#xD;
&#xD;
      Through the proposed study, the research team will capture patients' experience during this&#xD;
      unique and unprecedented time, in order to guide practice moving forwards and identify&#xD;
      potential areas for intervention. More specifically, the purpose of this study is to&#xD;
      understand the impact of COVID-19 restrictions on the wellbeing, quality of life and physical&#xD;
      activity of people with end-stage renal disease, currently dialysing in-centre versus at home&#xD;
      in the UK and their experience of telemedicine. This information may be used to help us&#xD;
      better support individuals in the future and investigate the feasibility of telemedicine in&#xD;
      routine clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>Day 1</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thematic analysis of qualitative interview exploring patients' experiences of telemedicine during the COVID-19 restrictions in the UK</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will be asked during a qualitative interview about their perceptions and experiences of telemedicine</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>in-centre</arm_group_label>
    <description>Currently dialysing in-centre</description>
  </arm_group>
  <arm_group>
    <arm_group_label>home</arm_group_label>
    <description>Currently dialysing at home</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with advanced ESRD (eGFR &lt; 15 mL/min/1.73m2) will be recruited into this study.&#xD;
&#xD;
        Persons falling into two distinct categories will be approached:&#xD;
&#xD;
          1. ESRD on ICHD&#xD;
&#xD;
          2. ESRD on HHD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Willing and able to undertake the interview process&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Does not provide written informed consent&#xD;
&#xD;
          -  Any neurological/psychiatric diagnoses&#xD;
&#xD;
          -  Lack of fluency in English&#xD;
&#xD;
          -  Individuals who have commenced RRT within three months of the study start date&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Sport, Health and Exercise Science</name>
      <address>
        <city>Portsmouth</city>
        <state>Outside The United States Or Canada</state>
        <zip>PO1 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Portsmouth</investigator_affiliation>
    <investigator_full_name>Dr Zoe Saynor</investigator_full_name>
    <investigator_title>Senior Lecturer in Physical Activity, Exercise and Health</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Transcripts will not be uploaded to repositories</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>July 22, 2022</submitted>
    <returned>June 9, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422873
org study id: 004
nct id: NCT04422873
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
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
description: 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
measure: Thematic analysis of qualitative interview exploring patients' experiences of telemedicine during the COVID-19 restrictions in the UK
time frame: Day 1
description: Participants will be asked during a qualitative interview about their perceptions and experiences of telemedicine
arm group label: in-centre
description: Currently dialysing in-centre
arm group label: home
description: Currently dialysing at home
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Portsmouth
investigator full name: Dr Zoe Saynor
investigator title: Senior Lecturer in Physical Activity, Exercise and Health
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: No
ipd description: Transcripts will not be uploaded to repositories
submitted: July 22, 2022
returned: June 9, 2023