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针对2型糖尿病患者的、与医院信息系统集成的电子糖尿病日记的开发与测试:一项混合方法研究的方案

Development and Testing of an Electronic Diabetes Diary Integrated With a Hospital Information System for Individuals With Type 2 Diabetes Mellitus: Protocol for a Mixed Methods Study.

作者信息

Skaria Geena, Reshmi Bhageerathy, K M Sabu, Shetty Sahana, Lakshmi R Vani

机构信息

Department of Health Information Management, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India.

Department of Endocrinology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India.

出版信息

JMIR Res Protoc. 2024 Jan 23;13:e50732. doi: 10.2196/50732.

Abstract

BACKGROUND

Type 2 diabetes mellitus (T2DM) is one of the leading noncommunicable diseases that require diabetes self-management (DSM) practices. This study proposes to develop a customized mobile health (mHealth) app integrated with a hospital information system (HIS) to enable real-time, two-way transfer of information between the patient and physician. The captured information in the electronic health record will facilitate physicians to have a chronological account of the patient's diabetes history and enable tweaking of the treatment.

OBJECTIVE

The objectives of the study are (1) to develop the HIS-integrated Electronic Diabetes Diary (EDDy) per the end-user expectations at a tertiary care hospital in a south Indian state with a high prevalence of T2DM and (2) to evaluate and test adherence to EDDy in the management of T2DM.

METHODS

The study will be carried out in 3 phases. Phase 1 involved in-depth interviews with primary end users to gather information regarding their expectations from the hospital-based EDDy. Phase 2 will use this information to develop a customized mHealth app using an iterative model of software development. Phase 3 will involve a pre- and posttest design; the developed app will be tested among consenting patients, where physicians will receive the patients' data through the HIS-integrated mHealth app. The pre- and posttest values will be analyzed for adherence leading to improvement in patients' self-management of blood glucose, user experience, glycemic control, and clinical utility.

RESULTS

Phase 1 was completed on November 28, 2023. Phase 2 commenced in December 2023 and will end in May 2025. Phase 3 will follow afterward.

CONCLUSIONS

The proposed app will include a convenient and simple alert system that enables the patient to test glucose values at self-selected intervals, provide grading options to enter diabetic-related complications, enhance patients' knowledge of tracking and managing the complications of diabetes, and help in maintaining the visual representation of glucose values and complications. The simplicity and usability of the modules are its novelty, which may motivate the patients to keep track of their glucose values and help them attain better health outcomes.

TRIAL REGISTRATION

Clinical Trial Registry India CTRI/2023/03/051077; http://tinyurl.com/4tau4ndb.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50732.

摘要

背景

2型糖尿病(T2DM)是需要糖尿病自我管理(DSM)措施的主要非传染性疾病之一。本研究提议开发一款与医院信息系统(HIS)集成的定制移动健康(mHealth)应用程序,以实现患者与医生之间信息的实时双向传输。电子健康记录中捕获的信息将有助于医生按时间顺序了解患者的糖尿病病史,并对治疗进行调整。

目的

本研究的目的是(1)根据印度南部一个T2DM高流行率邦的三级医疗医院终端用户的期望,开发与HIS集成的电子糖尿病日记(EDDy),以及(2)评估和测试在T2DM管理中对EDDy的依从性。

方法

本研究将分三个阶段进行。第1阶段包括对主要终端用户进行深入访谈,以收集他们对基于医院的EDDy的期望信息。第2阶段将利用这些信息,采用迭代软件开发模型开发一款定制的mHealth应用程序。第3阶段将采用前后测试设计;开发的应用程序将在同意参与的患者中进行测试,医生将通过与HIS集成的mHealth应用程序接收患者的数据。将分析前后测试值,以评估依从性,从而改善患者的血糖自我管理、用户体验、血糖控制和临床效用。

结果

第1阶段于2023年11月28日完成。第2阶段于2023年12月开始,将于2025年5月结束。随后将进行第3阶段。

结论

拟议的应用程序将包括一个方便简单的警报系统,使患者能够按自己选择的间隔测试血糖值,提供分级选项以输入糖尿病相关并发症,增强患者对跟踪和管理糖尿病并发症的认识,并有助于保持血糖值和并发症的直观呈现。这些模块的简单性和易用性是其新颖之处,这可能会促使患者跟踪自己的血糖值,并帮助他们获得更好的健康结果。

试验注册

印度临床试验注册中心CTRI/2023/03/051077;http://tinyurl.com/4tau4ndb。

国际注册报告识别码(IRRID):PRR1-10.2196/50732。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0cd9/10848138/478934c9792b/resprot_v13i1e50732_fig1.jpg

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