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Population-based Chronic Kidney Disease Cohort at Northern Taiwan

Primary Purpose

Chronic Kidney Disease, Population, Community, Multidisciplinary, Education

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

multidisciplinary renal education

About this trial

This is an interventional prevention trial for Chronic Kidney Disease, Population, Community, Multidisciplinary, Education

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

residents of Northern Taiwan

Exclusion Criteria:

pregnancy women, unwilling to participate

Sites / Locations

Department of Nephrology, Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

education arm

Arm Description

multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists.

Outcomes

Primary Outcome Measures

eGFR < 60 mL/min

change of renal function between groups

albuminuria/creatinine ratio >=30

change of proteinuria between groups

proteinuria/creatine ratio >=150

change of proteinuria between groups

Secondary Outcome Measures

SF-36

change of score between groups

Full Information

NCT ID

NCT03004898

First Posted

October 14, 2016

Last Updated

March 6, 2020

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03004898

Brief Title

Population-based Chronic Kidney Disease Cohort at Northern Taiwan

Official Title

Preventing Progression of Renal Disease by Multidisciplinary Education - A Cohort Study at Northern Taiwan.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Recruiting

Study Start Date

February 2013 (undefined)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

undefined (undefined)

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

CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education deep into the community remains limited. The aims of this study are: Explore risk factors associated with CKD in the community Establish multidisciplinary care model in the community Investigate mechanistic mediators for CKD and multidisciplinary education approached in behavioral , physiological, immune and metabolomics aspects Provide bio-specimen repository for future study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Population, Community, Multidisciplinary, Education

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

education arm

Arm Type

Experimental

Arm Description

multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists.

Intervention Type

Behavioral

Intervention Name(s)

multidisciplinary renal education

Intervention Description

multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.

Primary Outcome Measure Information:

Title

eGFR < 60 mL/min

Description

change of renal function between groups

Time Frame

through study completion, every 1 year

Title

albuminuria/creatinine ratio >=30

Description

change of proteinuria between groups

Time Frame

through study completion, every 1 year

Title

proteinuria/creatine ratio >=150

Description

change of proteinuria between groups

Time Frame

through study completion, every 1 year

Secondary Outcome Measure Information:

Title

SF-36

Description

change of score between groups

Time Frame

through study completion, every 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: residents of Northern Taiwan Exclusion Criteria: pregnancy women, unwilling to participate

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tsang-Tang Hsieh, MD

Phone

+886-2-27135211

Ext

3576

tth3388@adm.cgmh.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

I-Wen Wu, MD

Phone

+886-2-24313131

Ext

3170

fliawu@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

I-Wen Wu, MD

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nephrology, Chang Gung Memorial Hospital

City

Keelung

ZIP/Postal Code

204

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

I-Wen Wu, MD

Phone

+886-2-24313131

Ext

3170

fliawu@yahoo.com

First Name & Middle Initial & Last Name & Degree

I-Wen Wu, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19491379

Citation

Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2.

Results Reference

background

PubMed Identifier

21414969

Citation

Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17.

Results Reference

background

Learn more about this trial

Population-based Chronic Kidney Disease Cohort at Northern Taiwan

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