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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Diabetic Nephropathy
• Interventions: Behavioral: Community-based Integrated CKD Care

• Registration Number: NCT02194790
• Lead Sponsor: Bhumirajanagarindra Kidney Institute, Thailand

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 .

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Last Update Submitted: 2014-07-17
• Study First Posted: 2014-07-18
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
community-based Integrated CKD care	Community-based Integrated CKD Care	Standard CKD care + multidisciplinary team and home visit by community care team

Primary Outcome Measures

Name	Time	Method
The difference of rate of estimated glomerular filtration(eGFR) decline	12 months	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

Name	Time	Method
Change from baseline in low density lipoproteins(LDL)	12 months
Change from baseline in Random Urine Albumin to Creatinine Ratio	12 months
Change from baseline in waist circumference	12 months
Change from baseline in Hemoglobin A1C	12 months
Change from baseline in systolic blood pressure	12 months

Trial Locations

Locations (1)

Bhumirajanagarindra Kidney Institute; 🇹🇭 Bangkok, Thailand