Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.

Conditions
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Chronic Kidney Disease, Diabetic Nephropathy

Intervention / Treatment
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* Behavioral: Community-based Integrated CKD Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: community-based Integrated CKD care<br>Standard CKD care + multidisciplinary team and home visit by community care team | Behavioral: Community-based Integrated CKD Care<br>* 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<br>* Other names: Multidisciplnary clinic + home visit team;|
| No Intervention: Conventional CKD care<br>standard CKD care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Random Urine Albumin to Creatinine Ratio |  | 12 months | 
| Change from baseline in waist circumference |  | 12 months | 
| Change from baseline in low density lipoproteins(LDL) |  | 12 months | 
| Change from baseline in systolic blood pressure |  | 12 months | 
| Change from baseline in Hemoglobin A1C |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Diabetic Nephropathy, Integrated Chronic Kidney Disease Care