- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01509690
Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Singapore, Singapore
- Rekrytering
- National University Hospital
-
Kontakt:
- Priscilla P How, Pharm.D., BCPS
- Telefonnummer: (65)6516-4906
-
Huvudutredare:
- Priscilla P How, Pharm.D., BCPS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical (mortality and morbidity)
Tidsram: One year
|
Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)
|
One year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Laboratory outcomes
Tidsram: One year
|
Lab results
|
One year
|
|
Economic outcomes
Tidsram: One year
|
Direct and indirect medical costs
|
One year
|
|
Patient-reported outcomes
Tidsram: One-year
|
KDQOL and other social support questionnaires
|
One-year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Priscilla P How, Pharm.D., BCPS, National University of Singapore
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DSRB Domain E/2011/1772
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