Chronic Kidney Disease Prevention of An-Lo District, Keelung

NCT ID: NCT00644046

Last Updated: 2012-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Chronic Kidney Disease; End Stage Renal Disease; Death

Keywords

Chronic Kidney Disease; Prevention; Cardiovascular disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Chronic kidney disease patient with standardized nephrology care

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

chronic kidney disease patient with multidisciplinary predialysis care

Group Type: ACTIVE_COMPARATOR

multidisciplinary predialysis education

Intervention Type: BEHAVIORAL

teaching of renal knowledges, dietary support and recall of period medical visits

Interventions

multidisciplinary predialysis education

teaching of renal knowledges, dietary support and recall of period medical visits

Intervention Type: BEHAVIORAL

Other Intervention Names

MPE

Eligibility Criteria

Inclusion Criteria

• All CKD patients older than 18 y/o.

Exclusion Criteria

• Refusal to participate in the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

iwenwu

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iwen Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Division of Nephrology

Keelung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 14520619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17059992 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25398129 (View on PubMed)

Other Identifiers

CGMH-IRB-96-0408B

Identifier Type: -

Identifier Source: secondary_id

IWW-0001

Identifier Type: -

Identifier Source: org_study_id