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临床试验/NCT01587443
NCT01587443Unknown不适用

A Comparison of Patient-Reported, Economic and Clinical Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population

National University of Singapore1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Patient-Reported, Economic and Clinical Outcomes

研究概览

简要总结

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.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Patient-Reported, Economic and Clinical Outcomes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Priscilla How, Pharm.D., BCPS

Assistant Professor

National University of Singapore

研究点 (1)

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