Peoples Perceptions of Forms of Renal Replacement Therapy

NCT ID: NCT04427800

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2020-11-24

Brief 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.

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).

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

CKD G4

Chronic kidney disease stage (G4). (eGFR \< 30 mL/min/1.73m2)

No interventions assigned to this group

CKD G5

Chronic kidney disease stage (G5). (eGFR \< 15 mL/min/1.73m2) with imminent initiation of RRT

No interventions assigned to this group

ESRD on ICHD

End stage renal disease on in centre haemodialysis

No interventions assigned to this group

ESRD on HHD

End stage renal disease on home haemodialysis

No interventions assigned to this group

ESRD on PD

End stage renal disease on peritoneal dialysis

No interventions assigned to this group

Post-transplant

Participants post-transplant

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: collaborator

University of Portsmouth

OTHER

Sponsor Role: lead

Responsible Party

Dr Zoe Saynor

Senior Lecturer in Physical Activity, Exercise and Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Sport Health and Exercise Science

Portsmouth, Outside the United States Or Canada, United Kingdom

Countries

United Kingdom

Other Identifiers

005JA

Identifier Type: -

Identifier Source: org_study_id