NCT00644046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

3.4 years

First QC Date

March 20, 2008

Last Update Submit

September 5, 2012

Conditions

Chronic Kidney DiseaseEnd Stage Renal DiseaseDeath

Keywords

Chronic Kidney DiseasePreventionCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • reduction of estimated glomerular filtration rate by 50 %

    1 year

Secondary Outcomes (1)

  • death

    1 year

Study Arms (2)

1

NO INTERVENTION

Chronic kidney disease patient with standardized nephrology care

2

ACTIVE COMPARATOR

chronic kidney disease patient with multidisciplinary predialysis care

Behavioral: multidisciplinary predialysis education

Interventions

multidisciplinary predialysis educationBEHAVIORAL

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

Also known as: MPE
2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All CKD patients older than 18 y/o.

You may not qualify if:

  • Refusal to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Nephrology

Keelung, 204, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 14520619BACKGROUND

  • 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.

    PMID: 17059992BACKGROUND

  • 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.

    PMID: 25398129DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicDeathCardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Iwen Wu, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

July 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

TW(1)