Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
Primary Purpose
Chronic Kidney Disease, Diabetic Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Community-based Integrated CKD Care
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Diabetic Nephropathy, Integrated Chronic Kidney Disease Care
Eligibility Criteria
Inclusion Criteria:
- Diabetic patients with eGFR are equal or more than 60 ml/min/1.73m2 estimated twice at 3 months.
Exclusion Criteria:
- Active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).
Sites / Locations
- Bhumirajanagarindra Kidney Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
community-based Integrated CKD care
Conventional CKD care
Arm Description
Standard CKD care + multidisciplinary team and home visit by community care team
standard CKD care
Outcomes
Primary Outcome Measures
The difference of rate of estimated glomerular filtration(eGFR) decline
We compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.
Secondary Outcome Measures
Change from baseline in Random Urine Albumin to Creatinine Ratio
Change from baseline in waist circumference
Change from baseline in low density lipoproteins(LDL)
Change from baseline in systolic blood pressure
Change from baseline in Hemoglobin A1C
Full Information
NCT ID
NCT02194790
First Posted
July 17, 2014
Last Updated
July 17, 2014
Sponsor
Bhumirajanagarindra Kidney Institute, Thailand
Collaborators
Ministry of Health, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT02194790
Brief Title
Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
Official Title
Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bhumirajanagarindra Kidney Institute, Thailand
Collaborators
Ministry of Health, Thailand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have demonstrated that integrated pre-dialysis care may slow the decline in renal function (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early intervention especially in high risk groups like Diabetic may also improve outcome of these patients in primary health care setting resulting in delay of CKD progression.
Detailed Description
We conducted a 12-month longitudinal study at district A (control) and B (intervention) at Kamphaeng Phet Province, Thailand. Diabetic patients with eGFR ≥ 60 ml/min/1.73m2 were recruited from both districts. Patients in district A (control group) received standard CKD care according to NKF-K/DOQI guidelines1 whereas those in district B (intervention) received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers. During each hospital visit of both groups clinical data were assessed. All laboratory parameters were collected every 3 months, and LDL and HbA1C every 6 months. The primary end point was rate of eGFR decline. Secondary outcomes were random urine albumin to creatinine ratio (ACR), blood pressure, waist circumference, HbA1C and LDL .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Diabetic Nephropathy
Keywords
Chronic Kidney Disease, Diabetic Nephropathy, Integrated Chronic Kidney Disease Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
community-based Integrated CKD care
Arm Type
Experimental
Arm Description
Standard CKD care + multidisciplinary team and home visit by community care team
Arm Title
Conventional CKD care
Arm Type
No Intervention
Arm Description
standard CKD care
Intervention Type
Behavioral
Intervention Name(s)
Community-based Integrated CKD Care
Other Intervention Name(s)
Multidisciplnary clinic + home visit team
Intervention Description
Patients received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers
Primary Outcome Measure Information:
Title
The difference of rate of estimated glomerular filtration(eGFR) decline
Description
We compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Random Urine Albumin to Creatinine Ratio
Time Frame
12 months
Title
Change from baseline in waist circumference
Time Frame
12 months
Title
Change from baseline in low density lipoproteins(LDL)
Time Frame
12 months
Title
Change from baseline in systolic blood pressure
Time Frame
12 months
Title
Change from baseline in Hemoglobin A1C
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic patients with eGFR are equal or more than 60 ml/min/1.73m2 estimated twice at 3 months.
Exclusion Criteria:
Active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kotcharat Vipattawat, M.D.
Organizational Affiliation
Bhumirajanagarindra Kidney Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bhumirajanagarindra Kidney Institute
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
17276798
Citation
KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.
Results Reference
background
PubMed Identifier
22187469
Citation
American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
Results Reference
background
PubMed Identifier
21712852
Citation
Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.
Results Reference
background
PubMed Identifier
16332993
Citation
Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter T, Levey AS, Panteghini M, Welch M, Eckfeldt JH; National Kidney Disease Education Program Laboratory Working Group. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006 Jan;52(1):5-18. doi: 10.1373/clinchem.2005.0525144. Epub 2005 Dec 6.
Results Reference
background
PubMed Identifier
20441712
Citation
Black C, Sharma P, Scotland G, McCullough K, McGurn D, Robertson L, Fluck N, MacLeod A, McNamee P, Prescott G, Smith C. Early referral strategies for management of people with markers of renal disease: a systematic review of the evidence of clinical effectiveness, cost-effectiveness and economic analysis. Health Technol Assess. 2010 Apr;14(21):1-184. doi: 10.3310/hta14210.
Results Reference
background
PubMed Identifier
25018986
Citation
Cueto-Manzano AM, Martinez-Ramirez HR, Cortes-Sanabria L. Comparison of primary health-care models in the management of chronic kidney disease. Kidney Int Suppl (2011). 2013 May;3(2):210-214. doi: 10.1038/kisup.2013.16.
Results Reference
background
PubMed Identifier
21273376
Citation
Bayliss EA, Bhardwaja B, Ross C, Beck A, Lanese DM. Multidisciplinary team care may slow the rate of decline in renal function. Clin J Am Soc Nephrol. 2011 Apr;6(4):704-10. doi: 10.2215/CJN.06610810. Epub 2011 Jan 27.
Results Reference
background
PubMed Identifier
12748199
Citation
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.
Results Reference
background
PubMed Identifier
20037182
Citation
Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27.
Results Reference
result
PubMed Identifier
19414839
Citation
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.
Results Reference
result
PubMed Identifier
15114537
Citation
Kidney Disease Outcomes Quality Initiative (K/DOQI). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004 May;43(5 Suppl 1):S1-290. No abstract available.
Results Reference
result
PubMed Identifier
23067652
Citation
National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005. Erratum In: Am J Kidney Dis. 2013 Jun;61(6):1049.
Results Reference
result
Learn more about this trial
Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
We'll reach out to this number within 24 hrs