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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02194790
Enrollment
238
Registered
2014-07-18
Start date
2012-12-31
Completion date
2013-12-31
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Diabetic Nephropathy

Keywords

Chronic Kidney Disease, Diabetic Nephropathy, Integrated Chronic Kidney Disease Care

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 .

Interventions

BEHAVIORALCommunity-based Integrated CKD Care

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

Sponsors

Ministry of Health, Thailand
CollaboratorOTHER_GOV
Bhumirajanagarindra Kidney Institute, Thailand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
The difference of rate of estimated glomerular filtration(eGFR) decline12 monthsWe compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.

Secondary

MeasureTime frame
Change from baseline in Random Urine Albumin to Creatinine Ratio12 months
Change from baseline in waist circumference12 months
Change from baseline in low density lipoproteins(LDL)12 months
Change from baseline in systolic blood pressure12 months
Change from baseline in Hemoglobin A1C12 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026