- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978951
Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT)
Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background The unique characteristic of community-health care in Thailand is a system of primary- health care officers and Village Health Volunteers (VHVs) providing basic health care to more than 90% of Thai population. Should these allied personnel be trained on how to render proper chronic kidney disease (CKD) care, it would be interesting to study whether their role play care will result in better quality of CKD care.
Design This study is a community-based cluster randomized controlled trial to be conducted in 2 districts of Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. About 300 stage 3-4 CKD patients will be enrolled to each of the 2 treatment groups. Patients in both groups will be treated according to The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines. The District 1 (control group) patients will be provided a conventional CKD care. For the District 2 (intervention group) patients, an integrated CKD care program will be provided by the multidisciplinary team of district hospital in conjunction with the community CKD care networks (i.e. primary-health care officers and VHVs). The key activities of integrated CKD care program are live demonstration about treatment and optimal diets for CKD patients which will be provided during each hospital visit and quarterly home visits. Clinical and laboratory parameters of all cases will be assessed every 3 months. Duration of the study is 24 months. The primary outcome of this study is the rate of eGFR decline. The secondary outcomes are time of initiation of dialysis, cardiovascular mortality, and all-cause mortality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand, 10400
- Bhumirajanagarindra Kidney Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages 18-70 years and known to have diabetes and/or hypertension.
- eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
Exclusion Criteria:
- unstable/advanced cardiovascular disease
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Integrated Chronic Kidney Disease care
standard guidelines of CKD treatment + Integrated CKD care consisting of multidisciplinary team care and home visit by community care network
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Activities of integrated CKD care program, which will be provided during each hospital visit and quarterly home visits, are live demonstration about treatment and optimal diets for CKD patients, monitor drug compliance.
Other Names:
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ACTIVE_COMPARATOR: Conventional CKD care
standard guidelines of CKD treatment
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group counselling about optimal diets for CKD patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of rate of estimated glomerular filtration rate (eGFR) decline
Time Frame: 30 months
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We compare the difference of rate of estimated glomerular filtration rate (eGFR) decline between intervention group and control group from baseline to the end of the study.
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30 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Morbidity or Event
Time Frame: 24 months
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The definitions of cardiovascular event in this study are the numbers of myocardial infarction, stroke including ischemic and hemorrhagic event.
|
24 months
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Incidence of Initiation of Renal Replacement Therapy
Time Frame: 24 months
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Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation.
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24 months
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Hospitalization
Time Frame: 24 months
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The definitions of hospitalization in the study are any medical problem that relevant to cardiovascular disease and kidney problem which physician decide to admit the patients.
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24 months
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Change from baseline in Systolic Blood Pressure at 24 months
Time Frame: 24 months
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Blood pressure will be recorded twice with a sphygmomanometer with a 15-minute rest interval during each hospital visit of both groups
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24 months
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Change from baseline in amount of proteinuria at 24 months
Time Frame: 24 months
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Changes in amount of proteinuria which is measured by using urine protein-creatinine ratio.
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24 months
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Change from Baseline in Hemoglobin A1C at 24 months
Time Frame: 24 months
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We compare the difference of hemoglobin A1C of diabetic patients between intervention and control group.
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24 months
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Change from baseline in 24 hour urine sodium at 24 months
Time Frame: 24 months
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To evaluate amount of sodium intake, we compare the difference of 24 hour urine sodium between intervention group and control group.
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24 months
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Change from baseline in Protein Intake at 24 months
Time Frame: 24 months
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We compare the amount of protein intake by using normalized Protein Nitrogen Appearance, which will be calculated from 24 hour urine urea and ideal body weight.
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24 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Teerayuth Jiamjariyaporn, M.D., Bhumirajanagarindra Kidney Institute
Publications and helpful links
General Publications
- National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- 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. Erratum In: JAMA. 2003 Jul 9;290(2):197.
- 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. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.
- 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.
- Rastogi A, Linden A, Nissenson AR. Disease management in chronic kidney disease. Adv Chronic Kidney Dis. 2008 Jan;15(1):19-28. doi: 10.1053/j.ackd.2007.10.011.
- Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2.
- Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.
- 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.
- WHO, Role of Village Health Volunteers in Avian Influenza Surveillance in Thailand, WHO SEARO 2007
- WHO, Role of health volunteers in strengthening community action for health, Report of an Intercountry Consultation, Yangon 20-24 February 1995, WHO SEARO (SEA/HSD/198-1996)
- Kahssay, MH, Taylor, ME and Berman, PA, Community health workers: the way forward, WHO Geneva, 1998
- Witmer A, Seifer SD, Finocchio L, Leslie J, O'Neil EH. Community health workers: integral members of the health care work force. Am J Public Health. 1995 Aug;85(8 Pt 1):1055-8. doi: 10.2105/ajph.85.8_pt_1.1055.
- Rossing P, Rossing K, Gaede P, Pedersen O, Parving HH. Monitoring kidney function in type 2 diabetic patients with incipient and overt diabetic nephropathy. Diabetes Care. 2006 May;29(5):1024-30. doi: 10.2337/diacare.2951024.
- 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.
- Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
- Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.
- 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.
- 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.
- Kidney Disease Outcomes Quality Initiative (K/DOQI) Group. K/DOQI clinical practice guidelines for management of dyslipidemias in patients with kidney disease. Am J Kidney Dis. 2003 Apr;41(4 Suppl 3):I-IV, S1-91. No abstract available.
- Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S17-S104. doi: 10.1053/ajkd.2000.v35.aajkd03517. No abstract available. Erratum In: Am J Kidney Dis 2001 Oct;38(4):917.
- Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130. doi: 10.1038/ki.2009.188.
- 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.
- Peralta CA, Frigaard M, Rubinsky AD, Rolon L, Lo L, Voora S, Seal K, Tuot D, Chao S, Lui K, Chiao P, Powe N, Shlipak M. Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans. BMC Nephrol. 2017 Apr 12;18(1):132. doi: 10.1186/s12882-017-0541-6.
- Jiamjariyapon T, Ingsathit A, Pongpirul K, Vipattawat K, Kanchanakorn S, Saetie A, Kanistanon D, Wongprompitak P, Leesmidt V, Watcharasaksilp W, Wang W, Chandraker AK, Tungsanga K. Effectiveness of Integrated Care on Delaying Progression of stage 3-4 Chronic Kidney Disease in Rural Communities of Thailand (ESCORT study): a cluster randomized controlled trial. BMC Nephrol. 2017 Mar 2;18(1):83. doi: 10.1186/s12882-016-0414-4.
- Jiamjariyaporn T, Ingsathit A, Tungsanga K, Banchuin C, Vipattawat K, Kanchanakorn S, Leesmidt V, Watcharasaksilp W, Saetie A, Pachotikarn C, Taechangam S, Teerapornlertratt T, Chantarojsiri T, Sitprija V. Effectiveness of integrated care on delaying chronic kidney disease progression in rural communities of Thailand (ESCORT study): rationale and design of the study [NCT01978951]. BMC Nephrol. 2014 Jun 25;15:99. doi: 10.1186/1471-2369-15-99.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #07-004
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