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泰国农村社区综合护理对延缓慢性肾脏病进展的效果(ESCORT 研究):研究的原理和设计 [NCT01978951]。

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

机构信息

Bhumirajanagarindra Kidney Institute, Bangkok, Thailand.

出版信息

BMC Nephrol. 2014 Jun 25;15:99. doi: 10.1186/1471-2369-15-99.

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.

摘要

背景

在发展中国家,专科医生的可及性以及医患接触时间有限。在泰国,由区卫生保健官员和乡村卫生志愿者(VHV)提供独特的社区卫生服务。如果对这些人员进行适当的慢性肾脏病(CKD)护理培训,CKD 的进展将会延缓。

方法/设计:我们在位于曼谷以北约 400 公里的堪府府开展了一项以社区为基础的、集群随机对照试验。该省的 11 个区中随机选择了两个区。大约 500 名来自 2 个区的 3-4 期 CKD 患者被纳入研究。两组患者都将接受标准指南治疗。干预组患者将由多学科团队提供额外的治疗,并结合社区 CKD 护理网络(区卫生保健官员和 VHV)进行治疗,该网络将在每次就诊时提供小组咨询,并每季度进行家访,以监测饮食中蛋白质和钠的摄入量、血压测量和药物依从性。研究的持续时间为 2 年。主要结局是 eGFR 下降率的差异。次要结局是实验室参数和临床终点(如死亡率和心血管事件、终末期肾病(ESRD)等)的发生率。

讨论

这项研究的结果可能为社区为基础的 CKD 护理制定新的标准。

试验注册

NCT01978951。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7055/4079913/4366af7ce492/1471-2369-15-99-1.jpg

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