Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01587443
Recruitment Status : Unknown
Verified April 2015 by Priscilla How, Pharm.D., BCPS, National University, Singapore.
Recruitment status was:  Active, not recruiting
First Posted : April 30, 2012
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
Priscilla How, Pharm.D., BCPS, National University, Singapore

Brief 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 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.

Condition or disease
Stage 5 Chronic Kidney Disease Hemodialysis Peritoneal Dialysis

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Cross-Sectional
Official Title: A Comparison of Patient-Reported, Economic and Clinical Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population
Study Start Date : January 2012
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Peritoneal dialysis

Primary Outcome Measures :
  1. Patient-Reported, Economic and Clinical Outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage 5 chronic kidney disease hemodialysis peritoneal dialysis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Transient dialysis patients, those have poor cognitive function or are not able to complete the questionnaires or give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01587443

National University of Singapore
Singapore, Singapore
Sponsors and Collaborators
National University, Singapore
Principal Investigator: Priscilla P How, Pharm.D. National University, Singapore

Responsible Party: Priscilla How, Pharm.D., BCPS, Assistant Professor, National University, Singapore Identifier: NCT01587443     History of Changes
Other Study ID Numbers: DSRB Domain E/2011/02160
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency