Trial record 2 of 472 for:    Open Studies | "Renal Dialysis"

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
  Purpose

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
Stage 5 Chronic Kidney Disease
Hemodialysis
Peritoneal Dialysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National University, Singapore:

Primary Outcome Measures:
  • Patient-Reported, Economic and Clinical Outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 200
Groups/Cohorts
Hemodialysis
Peritoneal dialysis

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stage 5 chronic kidney disease hemodialysis peritoneal dialysis

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587443

Contacts
Contact: Priscilla P How, Pharm.D. (65)6516 4906 priscillahow@nus.edu.sg

Locations
Singapore
National University of Singapore Recruiting
Singapore, Singapore
Contact: Priscilla P How, Pharm.D.    (65)6516 4906    priscillahow@nus.edu.sg   
Sponsors and Collaborators
National University, Singapore
Investigators
Principal Investigator: Priscilla P How, Pharm.D. National University, Singapore
  More Information

No publications provided

Responsible Party: Priscilla How, Pharm.D., BCPS, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01587443     History of Changes
Other Study ID Numbers: DSRB Domain E/2011/02160
Study First Received: April 26, 2012
Last Updated: August 19, 2013
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on August 21, 2014