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Clinical Trials/NCT01509690
NCT01509690
Unknown
Phase 2

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 site in 1 country150 target enrollmentJanuary 13, 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stage 5 Chronic Kidney Disease
Sponsor
National University of Singapore
Enrollment
150
Locations
1
Primary Endpoint
Clinical (mortality and morbidity)
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Priscilla How, Pharm.D., BCPS

Assistant Professor

National University of Singapore

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Clinical (mortality and morbidity)

Time Frame: One year

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

Secondary Outcomes

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

Study Sites (1)

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