Clinical trial NCT00644046: Chronic Kidney Disease Prevention of An-Lo District, Keelung
Official title: Chronic Kidney Disease Prevention of An-Lo District, Keelung.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Death
Keywords: Chronic Kidney Disease
Prevention
Cardiovascular disease
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan (1, 2). More than 45,000 patients are under renal replacement therapy in the year 2004 (2). The disease had not only caused a significant impact in personal life, but also a great burden on social security and government-run health insurance. However, despite this high prevalence, the awareness of chronic kidney disease (CKD) in general population remains low (3, 4). The patients always come out too late for the intervention to slow down the progression of renal failure. Furthermore, most of them are not well prepared for the renal replacement therapy. The facts result in high mortality and morbidity in this specific population (5). It is mandatory to screen out and treat these patients early enough. However, these patients are deep into the community as the asymptomatic nature of CKD.

The major purpose of the study is to screen the community for the early CKD and provide the appropriate intervention at time. The study will collect the characteristic demographic epidemiological data and find out risk factors for CKD of this geographic area, provide multidisciplinary education of CKD and establish timely referral for appropriate nephrologist care for treatment and monitoring of complications.

Detailed description: The project will be last for 3 years. We will start to screen the patients within the community to identify the CKD population. This population will randomized into two group (one group with standard nephrologist care and another group with standard nephrologist care plus multidisciplinary CKD education) to evaluate the effectiveness of CKD education on the progression of renal function. The primary end-point will be the doubling tine estimated GFR, development of end-stage renal disease and all cause mortality. The non-CKD group of community will also follow up for urine and blood test for renal function, to determine the incidence and risk factors of new-onset renal disease. The accomplishment of this study will retard renal progression, improve community health and establish a model in preventing the chronic kidney disease.

Eligibility criteria: Inclusion Criteria:

* All CKD patients older than 18 y/o.

Exclusion Criteria:

* Refusal to participate in the trial

Primary outcomes:
measure: reduction of estimated glomerular filtration rate by 50 %
timeFrame: 1 year
Secondary outcomes:
measure: death
timeFrame: 1 year
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Division of Nephrology
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Iwen Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devins GM, Mendelssohn DC, Barre PE, Binik YM. Predialysis psychoeducational intervention and coping styles influence time to dialysis in chronic kidney disease. Am J Kidney Dis. 2003 Oct;42(4):693-703. doi: 10.1016/s0272-6386(03)00835-7.
citation: Hsu CC, Hwang SJ, Wen CP, Chang HY, Chen T, Shiu RS, Horng SS, Chang YK, Yang WC. High prevalence and low awareness of CKD in Taiwan: a study on the relationship between serum creatinine and awareness from a nationally representative survey. Am J Kidney Dis. 2006 Nov;48(5):727-38. doi: 10.1053/j.ajkd.2006.07.018.
citation: Yu YJ, Wu IW, Huang CY, Hsu KH, Lee CC, Sun CY, Hsu HJ, Wu MS. Multidisciplinary predialysis education reduced the inpatient and total medical costs of the first 6 months of dialysis in incident hemodialysis patients. PLoS One. 2014 Nov 14;9(11):e112820. doi: 10.1371/journal.pone.0112820. eCollection 2014.