Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care

Study Overview
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Brief Summary
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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: Explore risk factors associated with CKD Establish multidisciplinary care model for CKD patients Development cost-effective clinical care pathway for CKD Provide bio-specimen repository for future study

Detailed Description
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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: Explore risk factors associated with CKD: demographic, social and genetics factors Establish multidisciplinary care model for CKD patients Development cost-effective clinical care pathway for CKD Provide bio-specimen repository for future study: serum, PBMC, urine and stool

Official Title
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Biomarker and Multidisciplinary Predialysis Education in Chronic Kidney Disease Patients

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: multidisciplinary care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital Exclusion Criteria: Patient receiving dialysis or transplantation Unwilling to participate

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: customary care<br>customary care for CKD | |
| Active Comparator: multidisciplinary care<br>multidisciplinary team care for CKD | Behavioral: multidisciplinary care<br>* multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fold changes of proteins | change of levels between groups | through study completion, every 1 year | 
| fold changes of microRNA | change of levels between groups | through study completion, every 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk factors, omics, multidisciplinary care