Effectiveness of integrated care on delaying chronic kidney disease progression in rural communities of Thailand (ESCORT study): rationale and design of the study [NCT01978951]

Teerayuth Jiamjariyaporn, Atiporn Ingsathit, Kriang Tungsanga, Chatri Banchuin, Kotcharat Vipattawat, Suphattra Kanchanakorn, Vinai Leesmidt, Watcharapong Watcharasaksilp, Akhathai Saetie, Chanida Pachotikarn, Sunard Taechangam, Tanyarat Teerapornlertratt, Teerachai Chantarojsiri, Visith Sitprija, Teerayuth Jiamjariyaporn, Atiporn Ingsathit, Kriang Tungsanga, Chatri Banchuin, Kotcharat Vipattawat, Suphattra Kanchanakorn, Vinai Leesmidt, Watcharapong Watcharasaksilp, Akhathai Saetie, Chanida Pachotikarn, Sunard Taechangam, Tanyarat Teerapornlertratt, Teerachai Chantarojsiri, Visith Sitprija

Abstract

Background: In developing countries, accessibility to specialists, and physician to patient contact time is limited. In Thailand, A unique community health service is provided by subdistrict health care officers and Village Health Volunteers (VHVs). If the personnel were trained on proper chronic kidney disease (CKD) care, CKD progression would be delayed.

Methods/design: We conducted a community-based, cluster randomized controlled trial at Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. Two out of eleven districts of the province were randomly selected. Approximatly 500 stage 3-4 CKD patients from 2 districts were enrolled. Patients in both groups will be treated with standard guidelines. The patients in intervention group were provided the additional treatments by multidisciplinary team in conjunction with community CKD care network (subdistrict health care officers and VHVs) which will provide group counseling during each hospital visit and quarterly home visits to monitor dietary protein and sodium intake, blood pressure measurement and drug compliance. Duration of the study is 2 years. The primary outcome is the difference of rate of eGFR decline. The secondary outcomes are laboratory parameters and incidence of clinical endpoints such as mortality rate and cardiovascular events, end-stage renal disease (ESRD), etc.

Discussion: Insights of this study may set forth a new standard of community-based CKD care.

Trial registration: NCT01978951.

Figures

Figure 1
Figure 1
Map of Thailand.
Figure 2
Figure 2
Map of Kamphaeng Phet Province. The numbers represent respective districts of the Province. District No.5 and No.8 denote Khlong Khlung District (Intervention group) and Sai Thong Wattana District (Control group), respectively.
Figure 3
Figure 3
Design of the study.

References

    1. Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh A. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010;25:1567–1575.
    1. Rastogi A, Linden A, Nissenson AR. Disease management in chronic kidney disease. Adv Chronic Kidney Dis. 2008;15:19–28.
    1. 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;24(11):3426–3433.
    1. Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Sokora S, Ayers D, Parfrey P. 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.
    1. Role of village health volunteers in avian influenza surveillance in Thailand. WHO Annual Report. WHO Regional Office for South-East Asia (New Delhi); 2007.
    1. Witmer A, Seifer S, Finocchio L, Leslie J, O’Neil E. Community health workers: Integral members of the health care work force. Am J Public Health. 1995;85:1055–1058.
    1. Williams JR. The Declaration of Helsinki and public health. Bull World Health Organ. 2008;86(8):650–652.
    1. 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;150:604–612.
    1. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39:S1–S246.
    1. American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2010;33(Suppl 1):S11.
    1. Rossing P, Pedersen O, Parving HH, Rossing K, Gaede P. Monitoring kidney function in type 2 diabetic patients with incipient and overt diabetic nephropathy. Diabetes Care. 2006;29:1024–1030.
    1. Dupont WD, Plummer WD. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998;19:589–601.
    1. Saetie A, Pachotikarn C, Taechangam S, Jiamjariyaporn T, Cherdrungsi Y, Vuttisinaksara S, Pongreuk W. 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, 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;52:5–18.
    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.
    1. Twisk JWR, de Vente W. Attrition in longitudinal studies. How to deal with missing data. J Clin Epidemiol. 2002;55:329–337.
    1. Mahidol Population Gazette. Institute for Population and Social Research, Mahidol University, Volume 21. Bangkok: Population of Thailand; 2012.
    1. Rosenstock IM. The health belief model and preventive health behavior. Health Educ Monogr. 1974;2:329–386.

Source: PubMed

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