首页> 外文期刊>Contemporary Clinical Trials Communications >The use of text messaging for improving adherence to anti-diabetic regimen and glycaemic control in low-resource settings of South Africa: A study protocol for a randomised controlled trial
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The use of text messaging for improving adherence to anti-diabetic regimen and glycaemic control in low-resource settings of South Africa: A study protocol for a randomised controlled trial

机译:在南非的资源贫乏地区使用文本消息改善对抗糖尿病方案和血糖控制的依从性:一项随机对照试验的研究方案

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BackgroundDespite the various innovations and treatment modalities, diabetes treatment outcomes remain sub-optimal globally and in South Africa. This places significant strain on the healthcare system. Text messaging is a cost-effective measure for promoting health. Yet, its effectiveness in improving diabetes treatment outcomes has not been documented in South Africa, especially in the resource-restrained settings. This study aims as determining the effectiveness, feasibility and acceptability of text messaging in improving diabetes outcomes in low-resource settings of the Eastern Cape Province of South Africa.Methods and analysisThis is a multi-centre, two-arm, parallel, randomised controlled trial which will compare the use of text messaging in addition to diabetes standard care to standard care alone in promoting diabetes outcomes for six months. The study will be conducted at six primary healthcare centres in two selected districts in Eastern Cape, South Africa. The study requires 216 participants if an attrition rate of 20% is anticipated. Data will be collected at baseline and six months. Randomisation will follow baseline data collection using simple randomisation, with an allocation ratio of 1:1, after removing any identifying information. The primary outcome measure is a change in mean morning random blood sugar. Secondary outcomes include change in diabetes knowledge, medication adherence, self-management, health-related quality of life, mean blood pressure, weight and clinic attendance. Data will be obtained through self-reporting using validated measures, review of clinical records and objective measurements. Data collection and measurements will follow standard procedure. Data analysis will be based on the principle of Intention-to-treat.Trial registrationThis trial was registered in the Pan African Clinical Trial Registry, trial number: PACTR201810599931422.
机译:背景尽管有各种创新和治疗方式,但糖尿病治疗的结果在全球和南非仍然不理想。这给医疗保健系统带来了很大的压力。短信是一种促进健康的经济有效措施。但是,在南非,尤其是在资源紧张的地区,其改善糖尿病治疗效果的有效性尚未见文献记载。这项研究旨在确定在南非东开普省低资源环境中短信改善糖尿病结局的有效性,可行性和可接受性。方法与分析这是一项多中心,两臂,平行,随机对照试验它将在六个月内将除了糖尿病标准治疗之外的短信使用与仅标准治疗相比,单独用于标准治疗。该研究将在南非东开普的两个选定地区的六个主要医疗中心进行。如果预期损耗率为20%,则该研究需要216名参与者。数据将在基线和六个月时收集。在除去任何识别信息后,将使用简单的随机化方法以基线数据收集方式进行随机化,分配比率为1:1。主要结果指标是早晨平均血糖的变化。次要结果包括糖尿病知识,药物依从性,自我管理,与健康相关的生活质量,平均血压,体重和门诊量的变化。数据将通过使用有效量度的自我报告,临床记录的回顾和客观测量来获得。数据收集和测量将遵循标准程序。数据分析将基于意向性治疗的原则进行试验注册该试验已在泛非临床试验注册中心进行了注册,试验编号为PACTR201810599931422。

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