Chronic Kidney Disease, Population, Community, Multidisciplinary, Education Clinical Trial
Official title:
Preventing Progression of Renal Disease by Multidisciplinary Education - A Cohort Study at Northern Taiwan.
| NCT number | NCT03004898 |
| Other study ID # | IWW-0006 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2013 |
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
| Status | Recruiting |
| Enrollment | 10000 |
| Est. completion date | |
| Est. primary completion date | May 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - residents of Northern Taiwan Exclusion Criteria: - pregnancy women, unwilling to participate |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Department of Nephrology, Chang Gung Memorial Hospital | Keelung |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital |
Taiwan,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | eGFR < 60 mL/min | change of renal function between groups | through study completion, every 1 year | |
| Primary | albuminuria/creatinine ratio >=30 | change of proteinuria between groups | through study completion, every 1 year | |
| Primary | proteinuria/creatine ratio >=150 | change of proteinuria between groups | through study completion, every 1 year | |
| Secondary | SF-36 | change of score between groups | through study completion, every 1 year |