Clinical trial NCT02194790: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Diabetic Nephropathy
Keywords: Chronic Kidney Disease
Diabetic Nephropathy
Integrated Chronic Kidney Disease Care
Lead sponsor: Bhumirajanagarindra Kidney Institute, Thailand
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2014-07-18
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

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).

Primary outcomes:
measure: The difference of rate of estimated glomerular filtration(eGFR) decline
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Random Urine Albumin to Creatinine Ratio
timeFrame: 12 months
measure: Change from baseline in waist circumference
timeFrame: 12 months
measure: Change from baseline in low density lipoproteins(LDL)
timeFrame: 12 months
measure: Change from baseline in systolic blood pressure
timeFrame: 12 months
measure: Change from baseline in Hemoglobin A1C
timeFrame: 12 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Bhumirajanagarindra Kidney Institute
Study officials:
affiliation: Bhumirajanagarindra Kidney Institute
name: Kotcharat Vipattawat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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