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

N/ACompletedNCT02194790

Bhumirajanagarindra Kidney Institute, Thailand238 enrolled

Overview

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.

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

238

Conditions

Chronic Kidney Disease Diabetic Nephropathy

Interventions

Community-based Integrated CKD CareBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Locations (1)

Bhumirajanagarindra Kidney Institute

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Change from baseline in Random Urine Albumin to Creatinine Ratio

Time frame: 12 months

Change from baseline in waist circumference

Time frame: 12 months

Change from baseline in low density lipoproteins(LDL)

Time frame: 12 months

Change from baseline in systolic blood pressure

Time frame: 12 months

Change from baseline in Hemoglobin A1C

Time frame: 12 months

Data from ClinicalTrials.gov

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