<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/NCT04427800</url>
  </required_header>
  <id_info>
    <org_study_id>005JA</org_study_id>
    <nct_id>NCT04427800</nct_id>
  </id_info>
  <brief_title>Peoples Perceptions of Forms of Renal Replacement Therapy</brief_title>
  <official_title>An Exploration of People's Perceptions of Undergoing Treatment for Advanced Chronic Kidney Disease: a Comparison Between Different Treatment Modalities</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>
      Chronic kidney disease (CKD) causes symptoms and potential loss of independence. These&#xD;
      effects are increased as the disease progress to endstage renal disease (ESRD), particularly&#xD;
      when external intervention (i.e.&#xD;
&#xD;
      dialysis) is used to keep these individuals alive. The combined effect of ESRD and its&#xD;
      treatment has a significant impact on an individual's life, potentially causing reduced&#xD;
      employment time, reduced social time and increased anxiety/stress.&#xD;
&#xD;
      The purpose of this study is to investigate the impact that CKD/ESRD have on an individual's&#xD;
      life. Specifically, this study is focused on giving an insight into the psychosocial impact&#xD;
      that CKD/ESRD and different forms of renal replacement therapy have upon these individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic kidney disease (CKD) affects over 4% of the UK population, with approximately 118 per&#xD;
      million population commencing treatment for end-stage kidney disease each year (UK renal&#xD;
      registry, 2017). As enal function deteriorates, these individuals become progressively&#xD;
      symptomatic and require renal replacement therapy (RRT). CKD is split into five stages,&#xD;
      classified by their glomerular filtration rate (eGFR), with stages G4 and G5 representing&#xD;
      advanced disease preceding end-stage renal failure (Levey et al., 2005).&#xD;
&#xD;
      Along with diminished physical ability, cognitive function and quality of life (QoL) have&#xD;
      also been shown to deteriorate within this population (Abdel-Kader, Unruh, &amp; Weisbord, 2009).&#xD;
&#xD;
      Previous findings have shown that individuals with renal disease, particularly advanced&#xD;
      CKD/ESRD have a reduced QoL and substantial symptom burden, defined as a loss of functional&#xD;
      abilities along with psychological suffering affected by the impact of their symptoms (Gill,&#xD;
      Chakraborty, &amp; Selby, 2012). Of note, this seems to become particularly notable at the&#xD;
      initiation of RRT (Pagels, Söderkvist, Medin, Hylander, &amp; Heiwe, 2012). This supports&#xD;
      previous findings by Davison &amp; Jhangri (2010) and findings by Lowney et al (2015) who found&#xD;
      that individuals undergoing in-centre haemodialysis (HD) had a substantial symptom burden&#xD;
      which was associated with a reduced health-related QoL. This is significant because in-centre&#xD;
      HD (ICHD) is currently the most common form of RRT globally.&#xD;
&#xD;
      To date, no research has qualitatively examined the burden of other forms of RRT, such as&#xD;
      home haemodialysis (HHD), which is typically undertaken at home more frequently and for&#xD;
      shorter durations than ICHD; and peritoneal dialysis (PD), where the peritoneum is used as a&#xD;
      membrane through which excess fluid and toxins are removed from the body. A recent&#xD;
      investigation by Jones and colleagues (2018) explored the perceptions of UK-based individuals&#xD;
      undergoing ICHD within the National Health Service (NHS). Interestingly, several common&#xD;
      themes were identified; including fluctuations in their QoL and well-being over the course of&#xD;
      their HD therapy and restrictions in their social lives, due to HD scheduling and the heavy&#xD;
      emotional impact on themselves and others. These were shown to often be overlooked in the&#xD;
      literature, however, these factors have the potential to negatively impact an individual's&#xD;
      QoL and sense of self, defined as one's sense of purpose in life. Importantly, higher rates&#xD;
      of depression and anxiety have also been reported in individuals with CKD (Chen et al., 2010;&#xD;
      Semaan, Noureddine, &amp; Farhood, 2018). For example, Barros et al. (2016) found that greater&#xD;
      than 30% of individuals had depressive symptoms and reduced QoL. Furthermore, those found&#xD;
      with depressive symptoms tended to have a lower survival rate at the 2-year evaluation&#xD;
      period. It has been postulated that this increased prevalence in depressive symptoms could be&#xD;
      due to some significant psychosocial implications of CKD such as, reductions in employment,&#xD;
      social and personal time and interpersonal relationships (Finnegan-John &amp; Thomas, 2013),&#xD;
      supported by a recent (currently unpublished) investigation conducted by the research team&#xD;
      for this study at the Wessex Kidney Centre (WKC). During this study, it became clear through&#xD;
      informal discussions with people with ESRD and the treatment of this impacts their lives&#xD;
      greatly and that qualitative markers of QoL had the potential to be very insightful into the&#xD;
      impact of ESRD. Given the above, this study aims to investigate the QoL of adults at the&#xD;
      advanced stages of CKD (CKD stage G4 and G5) and those on all modalities of RRT (ICHD, HHD,&#xD;
      PD, and transplantation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2019</start_date>
  <completion_date type="Actual">November 24, 2020</completion_date>
  <primary_completion_date type="Actual">November 24, 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>Thematic analysis of qualitative interview exploring the experiences of renal disease and renal replacement therapy in adults with advanced chronic kidney disease and end-stage renal disease</measure>
    <time_frame>Day 1</time_frame>
    <description>Qualitative interviews to explore the above experiences</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>CKD G4</arm_group_label>
    <description>Chronic kidney disease stage (G4). (eGFR &lt; 30 mL/min/1.73m2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD G5</arm_group_label>
    <description>Chronic kidney disease stage (G5). (eGFR &lt; 15 mL/min/1.73m2) with imminent initiation of RRT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESRD on ICHD</arm_group_label>
    <description>End stage renal disease on in centre haemodialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESRD on HHD</arm_group_label>
    <description>End stage renal disease on home haemodialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESRD on PD</arm_group_label>
    <description>End stage renal disease on peritoneal dialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-transplant</arm_group_label>
    <description>Participants post-transplant</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with advanced CKD/ESRD (eGFR &lt; 30 mL/min/1.73m2&#xD;
&#xD;
        ) will be recruited into this study. Persons falling into six distinct categories will be&#xD;
        approached:&#xD;
&#xD;
          1. CKD G4&#xD;
&#xD;
          2. CKD G5 with imminent initiation of RRT&#xD;
&#xD;
          3. ESRD on ICHD&#xD;
&#xD;
          4. ESRD on HHD&#xD;
&#xD;
          5. ESRD on PD&#xD;
&#xD;
          6. Post-transplant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged 18 years or older Willing and able to undertake the interview process Able to give&#xD;
        informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age &lt; 18 years Does not provide written informed consent Any neurological/psychiatric&#xD;
        diagnoses Lack of fluency in English Individuals who have commenced RRT within three months&#xD;
        of the study start date Transplant patients being seen in clinic more than once every&#xD;
        fortnight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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>September 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 11, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 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>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Transcripts will not be uploaded to a repository</ipd_description>
  </patient_data>
  <!-- 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/NCT04427800
org study id: 005JA
nct id: NCT04427800
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic kidney disease (CKD) causes symptoms and potential loss of independence. These
      effects are increased as the disease progress to endstage renal disease (ESRD), particularly
      when external intervention (i.e.

      dialysis) is used to keep these individuals alive. The combined effect of ESRD and its
      treatment has a significant impact on an individual's life, potentially causing reduced
      employment time, reduced social time and increased anxiety/stress.

      The purpose of this study is to investigate the impact that CKD/ESRD have on an individual's
      life. Specifically, this study is focused on giving an insight into the psychosocial impact
      that CKD/ESRD and different forms of renal replacement therapy have upon these individuals.
Chronic kidney disease (CKD) affects over 4% of the UK population, with approximately 118 per
      million population commencing treatment for end-stage kidney disease each year (UK renal
      registry, 2017). As enal function deteriorates, these individuals become progressively
      symptomatic and require renal replacement therapy (RRT). CKD is split into five stages,
      classified by their glomerular filtration rate (eGFR), with stages G4 and G5 representing
      advanced disease preceding end-stage renal failure (Levey et al., 2005).

      Along with diminished physical ability, cognitive function and quality of life (QoL) have
      also been shown to deteriorate within this population (Abdel-Kader, Unruh, & Weisbord, 2009).

      Previous findings have shown that individuals with renal disease, particularly advanced
      CKD/ESRD have a reduced QoL and substantial symptom burden, defined as a loss of functional
      abilities along with psychological suffering affected by the impact of their symptoms (Gill,
      Chakraborty, & Selby, 2012). Of note, this seems to become particularly notable at the
      initiation of RRT (Pagels, Söderkvist, Medin, Hylander, & Heiwe, 2012). This supports
      previous findings by Davison & Jhangri (2010) and findings by Lowney et al (2015) who found
      that individuals undergoing in-centre haemodialysis (HD) had a substantial symptom burden
      which was associated with a reduced health-related QoL. This is significant because in-centre
      HD (ICHD) is currently the most common form of RRT globally.

      To date, no research has qualitatively examined the burden of other forms of RRT, such as
      home haemodialysis (HHD), which is typically undertaken at home more frequently and for
      shorter durations than ICHD; and peritoneal dialysis (PD), where the peritoneum is used as a
      membrane through which excess fluid and toxins are removed from the body. A recent
      investigation by Jones and colleagues (2018) explored the perceptions of UK-based individuals
      undergoing ICHD within the National Health Service (NHS). Interestingly, several common
      themes were identified; including fluctuations in their QoL and well-being over the course of
      their HD therapy and restrictions in their social lives, due to HD scheduling and the heavy
      emotional impact on themselves and others. These were shown to often be overlooked in the
      literature, however, these factors have the potential to negatively impact an individual's
      QoL and sense of self, defined as one's sense of purpose in life. Importantly, higher rates
      of depression and anxiety have also been reported in individuals with CKD (Chen et al., 2010;
      Semaan, Noureddine, & Farhood, 2018). For example, Barros et al. (2016) found that greater
      than 30% of individuals had depressive symptoms and reduced QoL. Furthermore, those found
      with depressive symptoms tended to have a lower survival rate at the 2-year evaluation
      period. It has been postulated that this increased prevalence in depressive symptoms could be
      due to some significant psychosocial implications of CKD such as, reductions in employment,
      social and personal time and interpersonal relationships (Finnegan-John & Thomas, 2013),
      supported by a recent (currently unpublished) investigation conducted by the research team
      for this study at the Wessex Kidney Centre (WKC). During this study, it became clear through
      informal discussions with people with ESRD and the treatment of this impacts their lives
      greatly and that qualitative markers of QoL had the potential to be very insightful into the
      impact of ESRD. Given the above, this study aims to investigate the QoL of adults at the
      advanced stages of CKD (CKD stage G4 and G5) and those on all modalities of RRT (ICHD, HHD,
      PD, and transplantation).
observational model: Cohort
time perspective: Cross-Sectional
measure: Thematic analysis of qualitative interview exploring the experiences of renal disease and renal replacement therapy in adults with advanced chronic kidney disease and end-stage renal disease
time frame: Day 1
description: Qualitative interviews to explore the above experiences
arm group label: CKD G4
description: Chronic kidney disease stage (G4). (eGFR < 30 mL/min/1.73m2)
arm group label: CKD G5
description: Chronic kidney disease stage (G5). (eGFR < 15 mL/min/1.73m2) with imminent initiation of RRT
arm group label: ESRD on ICHD
description: End stage renal disease on in centre haemodialysis
arm group label: ESRD on HHD
description: End stage renal disease on home haemodialysis
arm group label: ESRD on PD
description: End stage renal disease on peritoneal dialysis
arm group label: Post-transplant
description: Participants post-transplant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Renal Insufficiency, Chronic
sharing ipd: No
ipd description: Transcripts will not be uploaded to a repository