Stage 5 Chronic Kidney DiseaseNCT01587443
Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population
An observational study of Stage 5 Chronic Kidney Disease and Hemodialysis, run by National University of Singapore at 1 site in Singapore.
Trial summary
End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL) in dialysis patients measures the physical, social or emotional well-being that is affected by ESRD and/or its treatment, and has been… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stage 5 Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2012to Apr 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage 5 chronic kidney disease hemodialysis peritoneal dialysis
Who may be able to join
- All chronic HD and PD patients who are on regular follow-up with nephrologists in the NUH outpatient renal or PD clinic, and who meet the following criteria will be included in the study: male or female 21 years of age or older, with stage 5 CKD (eGFR <15 ml/min/1.73m2) and have been receiving HD or PD for at least 3 months.
Who cannot join
- Transient dialysis patients, those have poor cognitive function or are not able to complete the questionnaires or give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Patient-Reported, Economic and Clinical Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population
End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL) in dialysis patients measures the physical, social or emotional well-being that is affected by ESRD and/or its treatment, and has been increasingly used as an outcome measure in interventional studies. Additionally, associations between social support and QoL have been observed, indicating that improved social support could improve HRQoL, morbidity and mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social support between HD and PD patients in the multiethnic society of Singapore have not been evaluated. As such, the investigators propose to conduct this cross-sectional study in the investigators local multiethnic ESRD patient population to evaluate and compare patient-reported outcomes (HRQoL and social support), economic and clinical laboratory outcomes in HD and PD patients.
All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in this cross-sectional, observational study. Information on patient demographics, medical/medication histories, dialysis vintage, clinical laboratory data and associated medical costs will be obtained from clinic notes, electronic medical records and hospital databases. Patient-reported outcomes will be determined from scores of the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological Distress Scale and Health Services Utilization questionnaires (for indirect costs), and compared between HD and PD patients.
Results from this study will provide important HRQoL information to assist renal physicians and patients to make treatment decisions. Furthermore, intervention programs could be developed to improve social support based on patients' needs. These could in turn improve patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.
- 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 |
|---|---|---|
| Hemodialysis | Not described | |
| Peritoneal dialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported, Economic and Clinical Outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 5 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscilla How, Pharm.D., BCPS, National University of Singapore
- Investigators
- Priscilla P How, Pharm.D., Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587443
- Sponsor's protocol ID
- DSRB Domain E/2011/02160
- Status last verified
- Apr 2015
- First submitted
- 26 Apr 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Patient-Reported, Economic and Clinical Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population
- ClinicalTrials.gov ID
- NCT01587443
- Acronym / sponsor ID
- DSRB Domain E/2011/02160
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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.
End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL) in dialysis patients measures the physical, social or emotional well-being that is affected by ESRD and/or its treatment, and has been increasingly used as an outcome measure in interventional studies. Additionally, associations between social support and QoL have been observed, indicating that improved social support could improve HRQoL, morbidity and mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social support between HD and PD patients in the multiethnic society of Singapore have not been evaluated. As such, the investigators propose to conduct this cross-sectional study in the investigators local multiethnic ESRD patient population to evaluate and compare patient-reported outcomes (HRQoL and social support), economic and clinical laboratory outcomes in HD and PD patients.
All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in this cross-sectional, observational study. Information on patient demographics, medical/medication histories, dialysis vintage, clinical laboratory data and associated medical costs will be obtained from clinic notes, electronic medical records and hospital databases. Patient-reported outcomes will be determined from scores of the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological Distress Scale and Health Services Utilization questionnaires (for indirect costs), and compared between HD and PD patients.
Results from this study will provide important HRQoL information to assist renal physicians and patients to make treatment decisions. Furthermore, intervention programs could be developed to improve social support based on patients' needs. These could in turn improve patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | – | – |
| Peritoneal dialysis | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 5 chronic kidney disease hemodialysis peritoneal dialysis
Key inclusion criteria (1 listed)
- All chronic HD and PD patients who are on regular follow-up with nephrologists in the NUH outpatient renal or PD clinic, and who meet the following criteria will be included in the study: male or female 21 years of age or older, with stage 5 CKD (eGFR <15 ml/min/1.73m2) and have been receiving HD or PD for at least 3 months.
Key exclusion criteria (1 listed)
- Transient dialysis patients, those have poor cognitive function or are not able to complete the questionnaires or give informed consent.
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
Patient-Reported, Economic and Clinical Outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Priscilla P How, Pharm.D. principal investigator
National University of Singapore
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 Stage 5 Chronic Kidney Disease and Hemodialysis, run by National University of Singapore at 1 site in Singapore.
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: status not confirmed, as of the sponsor's last update on 15 Apr 2015. 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 Singapore. 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?
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?
Patient-Reported, Economic and Clinical Outcomes. 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 15 Apr 2015.