Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04427800 |
| Other study ID # |
005JA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 4, 2019 |
| Est. completion date |
November 24, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
University of Portsmouth |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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).
