Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- The difference of rate of estimated glomerular filtration(eGFR) decline
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Conventional CKD care
standard CKD care
community-based Integrated CKD care
Standard CKD care + multidisciplinary team and home visit by community care team
Intervention: Community-based Integrated CKD Care (Behavioral)
Outcomes
Primary Outcomes
The difference of rate of estimated glomerular filtration(eGFR) decline
Time Frame: 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 Outcomes
- 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)