Stage 5 Chronic Kidney Disease Clinical Trial
Official title:
Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02392299 -
Risk of Falling in Chronic Kidney Disease 5
|
||
Active, not recruiting |
NCT03602261 -
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
|
Phase 2 | |
Completed |
NCT02392208 -
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
|
Phase 4 | |
Active, not recruiting |
NCT01587443 -
Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population
|
N/A |