Chronic Kidney Disease, Population, Community, Multidisciplinary, EducationNCT03004898
Population-based Chronic Kidney Disease Cohort at Northern Taiwan
A study testing multidisciplinary renal education in people with Chronic Kidney Disease, Population, Community, Multidisciplinary, Education, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Population, Community, Multidisciplinary, Education
- What is being tested?
- multidisciplinary renal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2013to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents of Northern Taiwan
Who cannot join
- pregnancy women, unwilling to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Nephrology, Chang Gung Memorial Hospital
Keelung, 204
I-Wen Wu, MD, +886-2-24313131 ext. 3170, fliawu@yahoo.com
I-Wen Wu, MD
About this study
Official title: 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:
- 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
- Being tested
- multidisciplinary renal education
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary renal educationBehavioural
multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.
| Study group | Role | What they receive |
|---|---|---|
| education arm | Experimental | multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists. Receives: Behavioral: multidisciplinary renal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR < 60 mL/min
change of renal function between groups
Measured: through study completion, every 1 year
albuminuria/creatinine ratio >=30
change of proteinuria between groups
Measured: through study completion, every 1 year
proteinuria/creatine ratio >=150
change of proteinuria between groups
Measured: through study completion, every 1 year
Secondary outcomes (1)
SF-36
change of score between groups
Measured: through study completion, every 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startFeb 2013
- Primary completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease, Population, Community, Multidisciplinary, EducationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I Wen Wu, MD, Chang Gung Memorial Hospital
- Investigators
- I-Wen Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004898
- Sponsor's protocol ID
- IWW-0006
- Status last verified
- Mar 2020
- First submitted
- 14 Oct 2016
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19491379Chen 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.
PubMed 21414969
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Progression of Renal Disease by Multidisciplinary Education - A Cohort Study at Northern Taiwan.
- ClinicalTrials.gov ID
- NCT03004898
- Acronym / sponsor ID
- IWW-0006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2024 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| education arm | Experimental | Behavioral: multidisciplinary renal educationmultidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- residents of Northern Taiwan
Key exclusion criteria (1 listed)
- pregnancy women, unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary renal educationmultidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists. | Behavioural | education arm |
Primary outcome
eGFR < 60 mL/min
Time frame: through study completion, every 1 year
change of renal function between groups
albuminuria/creatinine ratio >=30
Time frame: through study completion, every 1 year
change of proteinuria between groups
proteinuria/creatine ratio >=150
Time frame: through study completion, every 1 year
change of proteinuria between groups
1 secondary outcome
SF-36
Time frame: through study completion, every 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 19491379Wu 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.
- Background: PubMed 21414969Chen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Wen Wu, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary renal education in people with Chronic Kidney Disease, Population, Community, Multidisciplinary, Education, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsang-Tang Hsieh, MD (+886-2-27135211 ext. 3576, tth3388@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR < 60 mL/min (time frame: through study completion, every 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004898, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.