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临床试验/NCT01509690
NCT01509690Unknown2 期

Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients

National University of Singapore1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年1月13日最近更新:
适应症

试验速览

阶段
2 期
入组人数
150
试验地点
1
主要终点
Clinical (mortality and morbidity)

研究概览

简要总结

Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the United States.

Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after HD initiation to focus on and streamline the management of dialysis issues and complications. These interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. The purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic Asian patients newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.

Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional management. Information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale and Health Services Utilization questionnaires. Data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

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 patients who are newly-initiated on HD 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)
  • newly-initiated on HD within the past 4-8 weeks of being seen in the NUH outpatient renal clinic

排除标准

  • transient HD patients
  • patients with poor cognitive function or are not able to complete the PRO questionnaires.

结局指标

主要结局

Clinical (mortality and morbidity)

时间窗: One year

Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)

次要结局

  • Patient-reported outcomes(One-year)
  • Economic outcomes(One year)
  • Laboratory outcomes(One year)

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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