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

NCT02194790 | Completed DMC

• 1 other identifier: CICC program
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Diabetic Nephropathy

Keywords

Chronic Kidney Disease; Diabetic Nephropathy; Integrated Chronic Kidney Disease Care

Outcome Measures

Primary Outcomes (1)

• The difference of rate of estimated glomerular filtration(eGFR) decline

  We compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.

  12 months

Secondary Outcomes (5)

• Change from baseline in Random Urine Albumin to Creatinine Ratio

  12 months

• Change from baseline in waist circumference

  12 months

• Change from baseline in low density lipoproteins(LDL)

  12 months

• Change from baseline in systolic blood pressure

  12 months

• Change from baseline in Hemoglobin A1C

  12 months

Study Arms (2)

community-based Integrated CKD care

EXPERIMENTAL

Standard CKD care + multidisciplinary team and home visit by community care team

Behavioral: Community-based Integrated CKD Care

Conventional CKD care

NO INTERVENTION

standard CKD care

Interventions

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

Also known as: Multidisciplnary clinic + home visit team

community-based Integrated CKD care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients with eGFR are equal or more than 60 ml/min/1.73m2 estimated twice at 3 months.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bhumirajanagarindra Kidney Institute, Thailand: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Bhumirajanagarindra Kidney Institute

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (12)

• KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.

  PMID: 17276798 BACKGROUND

• American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.

  PMID: 22187469 BACKGROUND

• Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.

  PMID: 21712852 BACKGROUND

• Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter T, Levey AS, Panteghini M, Welch M, Eckfeldt JH; National Kidney Disease Education Program Laboratory Working Group. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006 Jan;52(1):5-18. doi: 10.1373/clinchem.2005.0525144. Epub 2005 Dec 6.

  PMID: 16332993 BACKGROUND

• Black C, Sharma P, Scotland G, McCullough K, McGurn D, Robertson L, Fluck N, MacLeod A, McNamee P, Prescott G, Smith C. Early referral strategies for management of people with markers of renal disease: a systematic review of the evidence of clinical effectiveness, cost-effectiveness and economic analysis. Health Technol Assess. 2010 Apr;14(21):1-184. doi: 10.3310/hta14210.

  PMID: 20441712 BACKGROUND

• Cueto-Manzano AM, Martinez-Ramirez HR, Cortes-Sanabria L. Comparison of primary health-care models in the management of chronic kidney disease. Kidney Int Suppl (2011). 2013 May;3(2):210-214. doi: 10.1038/kisup.2013.16.

  PMID: 25018986 BACKGROUND

• Bayliss EA, Bhardwaja B, Ross C, Beck A, Lanese DM. Multidisciplinary team care may slow the rate of decline in renal function. Clin J Am Soc Nephrol. 2011 Apr;6(4):704-10. doi: 10.2215/CJN.06610810. Epub 2011 Jan 27.

  PMID: 21273376 BACKGROUND

• Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

  PMID: 12748199 BACKGROUND

• Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27.

  PMID: 20037182 RESULT

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 RESULT

• Kidney Disease Outcomes Quality Initiative (K/DOQI). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004 May;43(5 Suppl 1):S1-290. No abstract available.

  PMID: 15114537 RESULT

• National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.

  PMID: 23067652 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Kotcharat Vipattawat, M.D.

  Bhumirajanagarindra Kidney Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

TH (1)