search
Back to results

Chronic Kidney Disease Prevention of An-Lo District, Keelung

Primary Purpose

Chronic Kidney Disease, End Stage Renal Disease, Death

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
multidisciplinary predialysis education
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Prevention, Cardiovascular disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All CKD patients older than 18 y/o.

Exclusion Criteria:

  • Refusal to participate in the trial

Sites / Locations

  • Division of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Chronic kidney disease patient with standardized nephrology care

chronic kidney disease patient with multidisciplinary predialysis care

Outcomes

Primary Outcome Measures

reduction of estimated glomerular filtration rate by 50 %

Secondary Outcome Measures

death

Full Information

First Posted
March 20, 2008
Last Updated
September 5, 2012
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00644046
Brief Title
Chronic Kidney Disease Prevention of An-Lo District, Keelung
Official Title
Chronic Kidney Disease Prevention of An-Lo District, Keelung.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End Stage Renal Disease, Death
Keywords
Chronic Kidney Disease, Prevention, Cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Chronic kidney disease patient with standardized nephrology care
Arm Title
2
Arm Type
Active Comparator
Arm Description
chronic kidney disease patient with multidisciplinary predialysis care
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary predialysis education
Other Intervention Name(s)
MPE
Intervention Description
teaching of renal knowledges, dietary support and recall of period medical visits
Primary Outcome Measure Information:
Title
reduction of estimated glomerular filtration rate by 50 %
Time Frame
1 year
Secondary Outcome Measure Information:
Title
death
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All CKD patients older than 18 y/o. Exclusion Criteria: Refusal to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iwen Wu, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Nephrology
City
Keelung
ZIP/Postal Code
204
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
14520619
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.
Results Reference
background
PubMed Identifier
17059992
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.
Results Reference
background
PubMed Identifier
25398129
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.
Results Reference
derived

Learn more about this trial

Chronic Kidney Disease Prevention of An-Lo District, Keelung

We'll reach out to this number within 24 hrs