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

NCT ID: NCT02194790

Last Updated: 2014-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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 .

Conditions

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Chronic Kidney Disease Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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community-based Integrated CKD care

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

Group Type EXPERIMENTAL

Community-based Integrated CKD Care

Intervention Type 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

Conventional CKD care

standard CKD care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Multidisciplnary clinic + home visit team

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

Bhumirajanagarindra Kidney Institute, Thailand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kotcharat Vipattawat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bhumirajanagarindra Kidney Institute

Locations

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Bhumirajanagarindra Kidney Institute

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 17276798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22187469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21712852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16332993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20441712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25018986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21273376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12748199 (View on PubMed)

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.

Reference Type RESULT
PMID: 20037182 (View on PubMed)

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.

Reference Type RESULT
PMID: 19414839 (View on PubMed)

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.

Reference Type RESULT
PMID: 15114537 (View on PubMed)

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.

Reference Type RESULT
PMID: 23067652 (View on PubMed)

Other Identifiers

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CICC program

Identifier Type: -

Identifier Source: org_study_id

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