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

B

Bhumirajanagarindra Kidney Institute, Thailand

Status

Completed

Conditions

Diabetic Nephropathy
Chronic Kidney Disease

Treatments

Behavioral: Community-based Integrated CKD Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02194790
CICC program

Details and patient eligibility

About

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.

Full 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 .

Enrollment

238 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

238 participants in 2 patient groups

community-based Integrated CKD care
Experimental group
Description:
Standard CKD care + multidisciplinary team and home visit by community care team
Treatment:
Behavioral: Community-based Integrated CKD Care
Conventional CKD care
No Intervention group
Description:
standard CKD care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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