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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National University, Singapore
Sponsor:
Information provided by (Responsible Party):
Priscilla How, Pharm.D., BCPS, National University, Singapore
ClinicalTrials.gov Identifier:
NCT01587443
First received: April 26, 2012
Last updated: August 19, 2013
Last verified: August 2013

April 26, 2012
August 19, 2013
Not Provided
Not Provided
Patient-Reported, Economic and Clinical Outcomes [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01587443 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population
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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Stage 5 chronic kidney disease hemodialysis peritoneal dialysis

  • Stage 5 Chronic Kidney Disease
  • Hemodialysis
  • Peritoneal Dialysis
Not Provided
  • Hemodialysis
  • Peritoneal dialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
Not Provided

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.
Both
21 Years and older
No
Contact: Priscilla P How, Pharm.D. (65)6516 4906 priscillahow@nus.edu.sg
Singapore
 
NCT01587443
DSRB Domain E/2011/02160
No
Priscilla How, Pharm.D., BCPS, National University, Singapore
National University, Singapore
Not Provided
Principal Investigator: Priscilla P How, Pharm.D. National University, Singapore
National University, Singapore
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP