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OpenTrials
Completed

NCT Number: NCT02194790

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

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.

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Community-based Integrated CKD Care

Behavioral

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

Other names: Multidisciplnary clinic + home visit team

Primary outcomes

  1. 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

  1. Change from baseline in Random Urine Albumin to Creatinine Ratio

    Time frame: 12 months

  2. Change from baseline in waist circumference

    Time frame: 12 months

  3. Change from baseline in low density lipoproteins(LDL)

    Time frame: 12 months

  4. Change from baseline in systolic blood pressure

    Time frame: 12 months

  5. Change from baseline in Hemoglobin A1C

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bhumirajanagarindra Kidney Institute, Thailand

Other

Collaborators

  • Ministry of Health, Thailand

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2014
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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