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Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial

机译:EMPOWER-PAR干预在改善初级保健中2型糖尿病临床疗效方面的有效性:一项实用的集群随机对照试验

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Background The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. Methods This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1?year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c?Results A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. control: 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. control: ?4.1%, P Conclusions This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Trial registration Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.
机译:背景技术在发达国家,慢性病护理模式已被证明可有效改善糖尿病的临床结局。但是,发展中国家缺乏证据。这项研究的目的是使用马来西亚公共初级保健机构中可用的资源,评估EMPOWER-PAR干预(基于慢性护理模型)在改善2型糖尿病临床疗效方面的有效性。方法这是一项在马来西亚的10家公共初级保健诊所进行的,采用参与性行动研究方法的实用,成簇随机,平行,配对,对照试验。随机选择五家诊所提供EMPOWER-PAR干预1年,另外五家诊所继续常规护理。每个诊所在2周的时间内招募符合标准的患者。强制性干预的组成部分是根据慢性护理模型的四个要素设计的,即医疗保健组织,交付系统设计,自我管理支持和决策支持。主要结果是达到HbA1c的患者比例的改变。结果在基线时共招募888位2型糖尿病患者(干预:471 vs.对照组:417)。在1年时,干预组和对照组的96.6%和97.8%的患者分别完成了研究。两组的基线人口统计学和临床​​特征具有可比性。与对照组相比,干预组中达到HbA1c目标的患者比例变化显着更高(干预:3.0%vs.对照组:?4.1%,P结论)该研究表明,EMPOWER-PAR干预可有效改善HbA1c目标。马来西亚公共初级保健机构中2型糖尿病的主要结局。试验注册在以下网站注册:ClinicalTrials.gov .: NCT01545401。注册日期:2012年3月1日。

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