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A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial

机译:基于移动和基于网络的临床决策支持和监控系统,用于初级保健中的糖尿病患者:一项随机对照试验的研究方案

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Physicians’ guideline use rates for diagnosis, treatment and monitoring of diabetes mellitus (DM) is very low. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support and monitoring systems (CDSMS) provides an effective solution to these problems. The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for the screening, diagnosis, treatment, and monitoring of DM diseases which is used by physicians and patients in primary care and to determine the effectiveness of the system. The CDSMS will be based on evidence-based guidelines for DM disease. A web and mobile-based application will be developed in which the physician will remotely monitor patient data through mobile applications in real time. The developed CDSMS will be tested in two stages. In the first stage, the usability, understandability, and adequacy of the application will be determined. Five primary care physicians will use the developed application for at least 16 DM patients. Necessary improvements will be made according to physician feedback. In the second phase, a parallel, single-blind, randomized controlled trial will be implemented. DM diagnosed patients will be recruited for the CDSMS trial by their primary care physicians. Ten physicians and their 439 patients will be involved in the study. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p?
机译:医师诊断,治疗和监测糖尿病(DM)的准则使用率非常低。时间限制,患者人数过多以及复杂的准则要求实时监测患者的替代解决方案。迅速发展的电子医疗技术与临床决策支持和监视系统(CDSMS)相结合,为这些问题提供了有效的解决方案。该研究的目的是开发一种用户友好,全面,完全集成的基于Web和移动设备的临床决策支持和监控系统(CDSMS),用于筛查,诊断,治疗和监测DM疾病,供医师和医生使用。并确定患者在初级保健系统中的有效性。 CDSMS将基于针对DM疾病的循证指南。将开发基于Web和移动的应用程序,医生将在其中通过移动应用程序实时远程监视患者数据。所开发的CDSMS将分两个阶段进行测试。在第一阶段,将确定应用程序的可用性,可理解性和适当性。五名初级保健医生将为至少16名DM患者使用开发的应用程序。根据医生的反馈将进行必要的改进。在第二阶段,将进行平行,单盲,随机对照试验。 DM诊断的患者将由其初级保健医生招募参加CDSMS试验。这项研究将涉及10名医师及其439名患者。合格的参与者将通过简单的随机分配被分配到干预组和对照组。显着性水平将被接受为p≤0.05。在干预组中,系统将提出有关患者监测,诊断和治疗的建议。这些建议将由医生酌情实施。对照组的患者将根据当前的糖尿病治疗标准由医生治疗。两组患者均需监测6个月。将在研究的第0个月至第6个月之间比较患者数据。 。临床和实验室结果将亲自进行评估,而其他结果将在线进行自我评估。所开发的系统将是同类系统中第一个利用循证指南为DM患者提供健康服务的系统。 ClinicalTrials.gov NCT02917226。 2016年9月28日。

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