Chronic Kidney DiseasesNCT04427800
Peoples Perceptions of Forms of Renal Replacement Therapy
An observational study of Chronic Kidney Diseases, run by University of Portsmouth at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2019to 24 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Aged 18 years or older Willing and able to undertake the interview process Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport Health and Exercise Science
Portsmouth, Outside the United States Or Canada, PO1 2ER
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Qualitative interviews to explore the above experiences
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start4 Oct 2019
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University of Reading
- Responsible party
- Principal investigator, Dr Zoe Saynor, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427800
- Sponsor's protocol ID
- 005JA
- Status last verified
- Sep 2021
- First submitted
- 4 Jun 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Transcripts will not be uploaded to a repository
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of People's Perceptions of Undergoing Treatment for Advanced Chronic Kidney Disease: a Comparison Between Different Treatment Modalities
- ClinicalTrials.gov ID
- NCT04427800
- Acronym / sponsor ID
- 005JA
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University of Reading
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Aged 18 years or older Willing and able to undertake the interview process Able to give informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No. Transcripts will not be uploaded to a repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University of Portsmouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.