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

Teerayuth Jiamjariyapon, Atiporn Ingsathit, Krit Pongpirul, Kotcharat Vipattawat, Suphattra Kanchanakorn, Akhathai Saetie, Duangjit Kanistanon, Patimaporn Wongprompitak, Vinai Leesmidt, Watcharapong Watcharasaksilp, Wei Wang, Anil K Chandraker, Kriang Tungsanga, Teerayuth Jiamjariyapon, Atiporn Ingsathit, Krit Pongpirul, Kotcharat Vipattawat, Suphattra Kanchanakorn, Akhathai Saetie, Duangjit Kanistanon, Patimaporn Wongprompitak, Vinai Leesmidt, Watcharapong Watcharasaksilp, Wei Wang, Anil K Chandraker, Kriang Tungsanga

Abstract

Background: In developing countries, renal specialists are scarce and physician-to-patient contact time is limited. While conventional hospital-based, physician-oriented approach has been the main focus of chronic kidney disease (CKD) care, a comprehensive multidisciplinary health care program (Integrated CKD Care) has been introduced as an alternate intervention to delay CKD progression in a community population. The main objective is to assess effectiveness of Integrated CKD Care in delaying CKD progression.

Methods: We carried out a community-based, cluster randomized controlled trial. Four hundred forty-two stage 3-4 CKD patients were enrolled. In addition to the standard treatments provided to both groups, the patients in the intervention group also received "Integrated CKD Care". This was delivered by a multidisciplinary team of hospital staff in conjunction with a community CKD care network (subdistrict healthcare officers and village health volunteers) to provide group counseling during each hospital visit and quarterly home visits to monitor compliance with the treatment. Duration of the study was 2 years. The primary outcome was difference of mean eGFR between the intervention and the control groups over the study period.

Results: The mean difference of eGFR over time in the intervention group was significantly lower than the control group by 2.74 ml/min/1.73 m2 (95%CI 0.60-4.50, p = 0.009). Seventy composite clinical endpoints were reported during the study period with significantly different incidences between the control and the intervention groups (119.1 versus 69.4 per 1000 person-years; hazard ratio (HR) 0.59, 95% CI 0.4-0.9, p = 0.03).

Conclusion: Integrated CKD Care can delay CKD progression in resource-limited settings.

Trial registration: ( NCT01978951 ). Prospectively registered as of December 8, 2012.

Keywords: Chronic Kidney Disease; Integrated CKD care; Village health volunteers.

Figures

Fig. 1
Fig. 1
Flow chart of participants. Abbreviation: ESRD, End-stage renal disease
Fig. 2
Fig. 2
Changes in eGFR during the follow-up period (Primary outcome). GEE analyses were used to determine mean differences over time of estimated Glomerular Filtration Rate (eGFR) between intervention group and control group during the follow-up period
Fig. 3
Fig. 3
Changes in clinical and laboratory parameters during the follow-up period. GEE analyses were used to determine mean differences over time of clinical outcomes and laboratory parameters between the two groups. Change in systolic BP (a), diastolic BP (b), hemoglobin A1C (c), serum bicarbonate (d), serum triglyceride (e), urine protein-creatinine ratio (f), 24-h urine normalized protein nitrogen appearance (g), 24-h urine sodium (h) between intervention group and control group during the follow-up period

References

    1. Couser WG, Remuzzi G, Mendis S, Tonelli M. The contribution of chronic kidney disease to the global burden of major noncommunicable diseases. Kidney Int. 2011;80:1258–1270. doi: 10.1038/ki.2011.368.
    1. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic Kidney Disease and the Risks of Death, Cardiovascular Events, and Hospitalization. N Engl J Med. 2004;351:1296–1305. doi: 10.1056/NEJMoa041031.
    1. Tonelli M, Wiebe N, Culleton B, et al. Chronic Kidney Disease and Mortality Risk: A Systematic Review. J Am Soc Nephrol. 2006;17:2034–2047. doi: 10.1681/ASN.2005101085.
    1. Perkovic V, Cass A, Patel AA, et al. High prevalence of chronic kidney disease in Thailand. Kidney Int. 2008;73(4):473–479. doi: 10.1038/sj.ki.5002701.
    1. Ingsathit A, Thakkinstian A, Chaiprasert A, et al. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010;25:1567–1575. doi: 10.1093/ndt/gfp669.
    1. Rucker D, Hemmelgarn BR, Lin M, et al. Quality of care and mortality are worse in chronic kidney disease patients living in remote areas. Kidney Int. 2011;79:210–217. doi: 10.1038/ki.2010.376.
    1. Gæde P, Vedel P, Larsen N, Jensen GVH, Parving HH, Pedersen O. Multifactorial Intervention and Cardiovascular Disease in Patients with Type 2 Diabetes. N Engl J Med. 2003;348:383–393. doi: 10.1056/NEJMoa021778.
    1. Peeters JM, van Zuilen AD, van den Brand JA, et al. Nurse Practitioner Care Improves Renal Outcome in Patients with CKD. J Am Soc Nephrol. 2014;25(2):390–398. doi: 10.1681/ASN.2012121222.
    1. Wu IW, Wang SY, Hsu KH, et al. 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;24(11):3426–3433. doi: 10.1093/ndt/gfp259.
    1. Witmer A, Seifer S, Finocchio L, Leslie J, O’Neil EH. Community health workers: Integral members of the health care work force. Am J Public Health. 1995;85:1055–1058. doi: 10.2105/AJPH.85.8_Pt_1.1055.
    1. Kunaratanaprul S, Hanshaoworakul W, Peerapakorn S. Role of Village Health Volunteers in Avian Influenza Surveillance in Thailand. New Delhi: WHO Regional Office for South-East Asia; 2007.
    1. Getpreechaswas J, Boontorterm N, Yospol P. A model of health services for hypertension in primary care unit in Patumthani Province. J Med Assoc Thai. 2007;90(1):129–136.
    1. Migasena P. Role of village volunteers in a Food and Nutrition Monitoring System. J Med Assoc Thai. 1982;65(7):399–401.
    1. Jiamjariyaporn T, Ingsathit A, Tungsanga K, et al. Effectiveness of integrated care on delaying chronic kidney disease progression in rural commnunities of Thailand (ESCORT study) BMC Nephrol. 2014;15:99. doi: 10.1186/1471-2369-15-99.
    1. National Kidney Foundation, USA. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39:S1–246.
    1. Saetie A, Pachotikarn C, Taechangam S. The relative validation of easy dietary assessment tool using urine sodium and normalized protein nitrogen appearance as biomarkers. Ann Nutr Metab. 2013;63(suppl 1):1–1960.
    1. Myers GL, Miller WG, Coresh J, et al. 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;52:5–18. doi: 10.1373/clinchem.2005.0525144.
    1. Levey AS, Stevens LA, Schmid CH, et al. CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A New Equation to Estimate Glomerular Filtration Rate. Ann Intern Med. 2009;150:604–612. doi: 10.7326/0003-4819-150-9-200905050-00006.
    1. Lynette L, Seubsman S, Sleigh A. Thai SF-36 health survey: tests of data quality, scaling assumptions, reliability and validity in healthy men and women. Health Qual Life Outcomes. 2008;6:52. doi: 10.1186/1477-7525-6-52.
    1. Twisk JWR, de Vente W. Attrition in longitudinal studies. How to deal with missing data. J Clin Epidemiol. 2002;55:329–337. doi: 10.1016/S0895-4356(01)00476-0.
    1. Campbell K, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5561.
    1. Klahr S, Levey AS, Beck GJ, et al. The effects of dietary protein restriction and blood-pressure control on the progression of chronic renal disease. Modification of Diet in Renal Disease Study Group. N Engl J Med. 1994;330:877–884. doi: 10.1056/NEJM199403313301301.
    1. Slagman MC, Waanders F, Hemmelder MH, et al. Moderate dietary sodium restriction added to angiotensin converting enzyme inhibition compared with dual blockade in lowering proteinuria and blood pressure: randomised controlled trial. BMJ. 2011;343:d4366. doi: 10.1136/bmj.d4366.
    1. UK Prospective Diabetes Study (UKPDS) Group Intensive blood-glucose control with sulphonylureas or insulin compared with conventionaltreatment and risk of complications in patients with type 2 diabetes (UKPDS 33) Lancet. 1998;352:837–853. doi: 10.1016/S0140-6736(98)07019-6.
    1. Phisitkul S, Khanna A, Simoni J, et al. Amelioration of metabolic acidosis in patients with low GFR reduced kidney endothelin production and kidney injury, and better preserved GFR. Kidney Int. 2010;77:617–623. doi: 10.1038/ki.2009.519.
    1. Goraya N, Simoni J, Jo CH, et al. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014;86:1031–1038. doi: 10.1038/ki.2014.83.
    1. Keech A, Simes RJ, Barter P, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366:1849–1861. doi: 10.1016/S0140-6736(05)67667-2.
    1. Rosenstock IM. The health belief model and preventive health behavior. Health Educ Monogr. 1974;2:329–386.
    1. Mahidol Population Gazette, Institute for Population and Social Research, Mahidol University . Population of Thailand, Vol. 21. 2012.
    1. Lehmann U, Sanders D. Community health workers: What do we know about them? Geneva: Evidence and Information for Policy, Department of Human Resources for Health, World Health Organization; 2007.
    1. Barrett BJ, Garg AX, Goeree R, et al. 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;6:1241–1247. doi: 10.2215/CJN.07160810.
    1. Williams JR. The Declaration of Helsinki and public health. Bull World Health Organ. 2008;86(8):650–652. doi: 10.2471/BLT.08.050955.

Source: PubMed

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