Population-based Chronic Kidney Disease Cohort at Northern Taiwan

March 6, 2020 updated by: I Wen Wu, MD, Chang Gung Memorial Hospital

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

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:

  1. Explore risk factors associated with CKD in the community
  2. Establish multidisciplinary care model in the community
  3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in behavioral , physiological, immune and metabolomics aspects
  4. Provide bio-specimen repository for future study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Keelung, Taiwan, 204
        • Recruiting
        • Department of Nephrology, Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • I-Wen Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • residents of Northern Taiwan

Exclusion Criteria:

  • pregnancy women, unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: education arm
multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists.
Behavioral: multidisciplinary renal education
multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR < 60 mL/min
Time Frame: through study completion, every 1 year
change of renal function between groups
through study completion, every 1 year
albuminuria/creatinine ratio >=30
Time Frame: through study completion, every 1 year
change of proteinuria between groups
through study completion, every 1 year
proteinuria/creatine ratio >=150
Time Frame: through study completion, every 1 year
change of proteinuria between groups
through study completion, every 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36
Time Frame: through study completion, every 1 year
change of score between groups
through study completion, every 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: I-Wen Wu, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IWW-0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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