HemodialysisePISTLENCT04225416
Perceptions of Illness Severity, Treatment Goals and Life Expectancy
An observational study of Hemodialysis and Peritoneal Dialysis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemodialysis, Peritoneal Dialysis
- What is being tested?
- Questionnaire/Structured Interview
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Nov 2018to 1 Nov 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dialysis patients
Who may be able to join
- Haemodialysis patients 18-100 years old, with a predicted mortality risk of >20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
- Peritoneal dialysis patients 18-100 years old, with a predicted mortality risk of >20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
Who cannot join
- Patients on home haemodialysis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Hannah Beckwith, 02033131000, hannah.beckwith@nhs.net
About this study
Official title: The ePISTLE Study: Perceptions of Illness Severity, Treatment Goals and Life Expectancy
This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.
Read the detailed description
Sharing and communicating information with patients is an integral part of medical care, yet research has shown that disparities exist between physicians and patient perceptions of illness severity. In renal medicine, along with many other specialties, expected prognosis can affect treatment offered.Thus appreciating and understanding one's prognosis can influence patients and relatives' expectations for treatment and guide discussions regarding quality of life.
Previous work has highlighted disparities in the United States between expectations of survival of seriously ill haemodialysis patients and their physicians. The investigators plan to repeat this study within the United Kingdom, to see whether similar issues occur and to elucidate current practice on discussions of prognosis, symptom burden and transplant candidacy. The investigators hope to identify where care can be improved and to enable patients to better make informed decisions on treatment and goals of care.
Part one of the study is to repeat this study in haemodialysis patients in the United Kingdom. This has been completed and published (2021) at https://www.kireports.org/article/S2468-0249(21)00103-0/fulltext.
Part two of the study is to extend the study to peritoneal dialysis patients in the United Kingdom.
- Conditions
- Hemodialysis, Peritoneal Dialysis
- Being tested
- Questionnaire/Structured Interview
- Keywords
- hemodialysis, peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire/Structured InterviewOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Patients undergoing hemodialysis Receives: Other: Questionnaire/Structured Interview | |
| Peritoneal dialysis patients | Patients undergoing peritoneal dialysis Receives: Other: Questionnaire/Structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current practice regarding discussion of prognosis with seriously ill dialysis patients, to better understand the dissonance between physician and patient beliefs on prognosis, transplant candidacy and goals of care.
Completion of questionnaire or structured interview
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Number of dialysis patients who are more optimistic about prognosis and transplant candidacy than their nephrologists
Completion of questionnaire or structured interview
Measured: Through study completion, an average of 2 years
Patients' prognostic expectations are associated with their treatment preferences
Completion of questionnaire or structured interview
Measured: Through study completion, an average of 2 years
Number of patients with dialysis associated symptoms as assessed by IPOS Renal (https://pos-pal.org/maix/ipos-renal-in-english.php).
Completion of questionnaire or structured interview
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start16 Nov 2018
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edwina Brown, MBChB, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225416
- Sponsor's protocol ID
- 18HH4336
- Acronym
- ePISTLE
- Status last verified
- Oct 2022
- First submitted
- 6 Jan 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ePISTLE Study: Perceptions of Illness Severity, Treatment Goals and Life Expectancy
- ClinicalTrials.gov ID
- NCT04225416
- Acronym / sponsor ID
- ePISTLE / 18HH4336
- Conditions
- Hemodialysis, Peritoneal Dialysis
- Keywords
- hemodialysis, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Jan 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.
This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.
Detailed description
Sharing and communicating information with patients is an integral part of medical care, yet research has shown that disparities exist between physicians and patient perceptions of illness severity. In renal medicine, along with many other specialties, expected prognosis can affect treatment offered.Thus appreciating and understanding one's prognosis can influence patients and relatives' expectations for treatment and guide discussions regarding quality of life.
Previous work has highlighted disparities in the United States between expectations of survival of seriously ill haemodialysis patients and their physicians. The investigators plan to repeat this study within the United Kingdom, to see whether similar issues occur and to elucidate current practice on discussions of prognosis, symptom burden and transplant candidacy. The investigators hope to identify where care can be improved and to enable patients to better make informed decisions on treatment and goals of care.
Part one of the study is to repeat this study in haemodialysis patients in the United Kingdom. This has been completed and published (2021) at https://www.kireports.org/article/S2468-0249(21)00103-0/fulltext.
Part two of the study is to extend the study to peritoneal dialysis patients in the United Kingdom.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Other: Questionnaire/Structured InterviewPatients undergoing hemodialysis |
| Peritoneal dialysis patients | – | Other: Questionnaire/Structured InterviewPatients undergoing peritoneal dialysis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dialysis patients
Key inclusion criteria (2 listed)
- Haemodialysis patients 18-100 years old, with a predicted mortality risk of >20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
- Peritoneal dialysis patients 18-100 years old, with a predicted mortality risk of >20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
Key exclusion criteria (1 listed)
- Patients on home haemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire/Structured InterviewNo intervention | Other | Hemodialysis patients, Peritoneal dialysis patients |
Primary outcome
Current practice regarding discussion of prognosis with seriously ill dialysis patients, to better understand the dissonance between physician and patient beliefs on prognosis, transplant candidacy and goals of care.
Time frame: Through study completion, an average of 2 years
Completion of questionnaire or structured interview
3 secondary outcomes
Number of dialysis patients who are more optimistic about prognosis and transplant candidacy than their nephrologists
Time frame: Through study completion, an average of 2 years
Patients' prognostic expectations are associated with their treatment preferences
Time frame: Through study completion, an average of 2 years
Number of patients with dialysis associated symptoms as assessed by IPOS Renal (https://pos-pal.org/maix/ipos-renal-in-english.php).
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Edwina Brown, MBChB principal investigator
Imperial College London
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 Hemodialysis and Peritoneal Dialysis, run by Imperial College London 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 2 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Beckwith, MBChB (02033131000, hannah.beckwith@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current practice regarding discussion of prognosis with seriously ill dialysis patients, to better understand the dissonance between physician and patient beliefs on prognosis, transplant candidacy and goals of care. (time frame: Through study completion, an average of 2 years). 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 20 Oct 2022.