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

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ClinicalTrials.gov Identifier: NCT02194790
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Bhumirajanagarindra Kidney Institute, Thailand

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Diabetic Nephropathy Behavioral: Community-based Integrated CKD Care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: community-based Integrated CKD care
Standard CKD care + multidisciplinary team and home visit by community care team
 Behavioral: Community-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
Other Name: Multidisciplnary clinic + home visit team
No Intervention: Conventional CKD care
standard CKD care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194790


Locations
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Thailand
Bhumirajanagarindra Kidney Institute
Bangkok, Thailand, 10400
Sponsors and Collaborators
Bhumirajanagarindra Kidney Institute, Thailand
Ministry of Health, Thailand
Investigators
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Principal Investigator: Kotcharat Vipattawat, M.D. Bhumirajanagarindra Kidney Institute
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Bhumirajanagarindra Kidney Institute, Thailand
ClinicalTrials.gov Identifier: NCT02194790    
Other Study ID Numbers: CICC program
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Keywords provided by Bhumirajanagarindra Kidney Institute, Thailand:
Chronic Kidney Disease
Diabetic Nephropathy
Integrated Chronic Kidney Disease Care
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Urologic Diseases
 Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases