Peoples Perceptions of Forms of Renal Replacement Therapy

September 27, 2021 updated by: Dr Zoe Saynor, University of Portsmouth

An Exploration of People's Perceptions of Undergoing Treatment for Advanced Chronic Kidney Disease: a Comparison Between Different Treatment Modalities

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.

Study Overview

Status

Completed

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Outside The United States Or Canada
      • Portsmouth, Outside The United States Or Canada, United Kingdom, PO1 2ER
        • School of Sport Health and Exercise Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with advanced CKD/ESRD (eGFR < 30 mL/min/1.73m2

) will be recruited into this study. Persons falling into six distinct categories will be approached:

  1. CKD G4
  2. CKD G5 with imminent initiation of RRT
  3. ESRD on ICHD
  4. ESRD on HHD
  5. ESRD on PD
  6. Post-transplant

Description

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 Transplant patients being seen in clinic more than once every fortnight

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
CKD G4
Chronic kidney disease stage (G4). (eGFR < 30 mL/min/1.73m2)
CKD G5
Chronic kidney disease stage (G5). (eGFR < 15 mL/min/1.73m2) with imminent initiation of RRT
ESRD on ICHD
End stage renal disease on in centre haemodialysis
ESRD on HHD
End stage renal disease on home haemodialysis
ESRD on PD
End stage renal disease on peritoneal dialysis
Post-transplant
Participants post-transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Qualitative interviews to explore the above experiences
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Actual)

November 24, 2020

Study Completion (Actual)

November 24, 2020

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 005JA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Transcripts will not be uploaded to a repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

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