NCT04300387

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. Early diagnosis of disease and proper management remain challenging. The aims of this study are:

  1. 1.Explore risk factors associated with CKD
  2. 2.Establish multidisciplinary care model for CKD patients
  3. 3.Development cost-effective clinical care pathway for CKD
  4. 4.Provide bio-specimen repository for future study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2011

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

13.8 years

First QC Date

September 30, 2016

Last Update Submit

March 6, 2020

Conditions

Chronic Kidney Disease

Keywords

risk factorsomicsmultidisciplinary care

Outcome Measures

Primary Outcomes (2)

  • percentage (%)

    percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality

    through study completion, every 1 year

  • difference of US dollars

    differences of US dollars of medical care (out patients and inpatients service fees) between groups

    through study completion, every 1 year

Secondary Outcomes (2)

  • fold changes of proteins

    through study completion, every 1 year

  • fold changes of microRNA

    through study completion, every 1 year

Other Outcomes (2)

  • change of taxonomic units abundance of specific microbiota

    through study completion, every 1 year

  • changes of metabolites

    through study completion, every 1 year

Study Arms (2)

customary care

NO INTERVENTION

customary care for CKD

multidisciplinary care

ACTIVE COMPARATOR

multidisciplinary team care for CKD

Behavioral: multidisciplinary care

Interventions

multidisciplinary careBEHAVIORAL

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

multidisciplinary care

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital

You may not qualify if:

  • Patient receiving dialysis or transplantation
  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 204, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19491379RESULT

  • 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.

    PMID: 21414969RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Patient Care Team

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • I-Wen Wu

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsang-Tang Hsieh

CONTACT

+886-2-27135211tth3388@adm.cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2016

First Posted

March 9, 2020

Study Start

March 1, 2011

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

TW(1)