Health Information Management Research Center, Kashan University of Medical Sciences, Kashan, Iran.
Department of Health Information Management & Technology, Kashan University of Medical Sciences, Kashan, Iran.
BMC Med Inform Decis Mak. 2022 Nov 11;22(1):292. doi: 10.1186/s12911-022-02033-y.
Stroke is the main leading cause of long-term disabilities in the world. This protocol will be implemented for a study to evaluate the effects of an Android-based self-care application on patients with stroke.
The first stage will include the development of an android-based application using JAVA programming language for developing the user interface and ASP.NET Core for developing Web server. The second stage will be conducted using triple blinded randomized clinical trial (RCT). The sample size will include 60 patients with recent stroke and partial paralysis of limbs, who will be divided into two groups of intervention and control through permuted block randomization method. Patients in both groups will receive usual medical care, but those in the intervention group will also use an Android-based application for a period of two months. Outcomes will be assessed using valid and reliable questionnaires.
The assessed outcomes will include stroke severity using National Institute of Health Stroke Scale (NIHSS) score, ability to perform activities of daily living using Barthel Index (BI) score, depression rate using Beck Depression Inventory (BDI-II) score, quality of life using EQ-5D-3L score, medication adherence using Modified Morisky Medication Adherence Scale (MMAS-8) score, patient satisfaction using Patient Satisfaction Questionnaire (PSQ) score and the number and type of complications in patients in two groups. These outcomes will be assessed at baseline, after two months and after three months from the beginning of the intervention. Intervention effects on the measured variables will also be evaluated using appropriate statistical tests based on the type of variable distribution. Potential consequences of the study might be the improvement of the measured variables in the intervention group compared to that of the control group. The expected results are that the intervention may significantly improve the status of the measured variables in the intervention group compared to that of the control group. If the outcomes of the intervention group do not change significantly compared to those of the control group, it can be due to different reasons. However, this can most likely be attributed to incorrect or insufficient use of the application by patients.
This protocol is registered in the Iranian registration of clinical trial (IRCT) on November 7, 2020 with the code IRCT20201015049037N1. URL: https://irct.ir/trial/51674.
中风是全球导致长期残疾的主要原因。本研究旨在评估基于安卓的自我护理应用对中风患者的影响，将实施此方案。
第一阶段将使用 JAVA 编程语言开发基于安卓的应用程序，用于开发用户界面，以及使用 ASP.NET Core 开发 Web 服务器。第二阶段将采用三盲随机临床试验（RCT）进行。样本量包括 60 名近期中风且四肢部分瘫痪的患者，将通过区组随机化方法分为干预组和对照组。两组患者均接受常规医疗护理，但干预组还将在两个月的时间内使用基于安卓的应用程序。使用有效且可靠的问卷评估结果。
评估结果将包括使用国立卫生研究院中风量表（NIHSS）评分评估中风严重程度、使用巴氏指数（BI）评分评估日常生活活动能力、使用贝克抑郁量表第二版（BDI-II）评分评估抑郁程度、使用 EQ-5D-3L 评分评估生活质量、使用修正莫斯里服药依从性量表（MMAS-8）评分评估药物依从性、使用患者满意度问卷（PSQ）评分评估患者满意度以及两组患者的并发症数量和类型。这些结果将在基线、干预两个月后和三个月后进行评估。还将根据变量分布类型，使用适当的统计检验评估干预对测量变量的影响。研究的潜在后果可能是干预组测量变量的改善与对照组相比。预期结果是，与对照组相比，干预组的测量变量可能会显著改善。如果干预组的结果与对照组相比没有明显变化，则可能是由于患者对应用程序的使用不正确或不充分所致。
本方案于 2020 年 11 月 7 日在伊朗临床试验注册中心（IRCT）注册，注册号为 IRCT20201015049037N1。网址：https://irct.ir/trial/51674。
