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e-Monitoring of Asthma Therapy to Improve Compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol

机译:使用实时药物监测系统(RTMM)对哮喘治疗进行电子监测以提高儿童的依从性:e-MATIC研究方案

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Background Many children with asthma do not have sufficient asthma control, which leads to increased healthcare costs and productivity loss of parents. One of the causative factors are adherence problems. Effective interventions improving medication adherence may therefore improve asthma control and reduce costs. A promising solution is sending real time text-messages via the mobile phone network, when a medicine is about to be forgotten. As the effect of real time text-messages in children with asthma is unknown, the primary aim of this study is to determine the effect of a Real Time Medication Monitoring system (RTMM) with text-messages on adherence to inhaled corticosteroids (ICS). The secondary objective is to study the effects of RTMM on asthma control, quality of life and cost-effectiveness of treatment. Methods A multicenter, randomized controlled trial involving 220 children (4–11?years) using ICS for asthma. All children receive an RTMM-device for one year, which registers time and date of ICS doses. Children in the intervention group also receive tailored text-messages, sent only when a dose is at risk of omission. Primary outcome measure is the proportion of ICS dosages taken within the individually predefined time-interval. Secondary outcome measures include asthma control (monthly Asthma Control Tests), asthma exacerbations, healthcare use (collected from hospital records, patient reports and pharmacy record data), and disease-specific quality of life (PAQLQ questionnaire). Parental and children’s acceptance of RTMM is evaluated with online focus groups and patient questionnaires. An economic evaluation is performed adopting a societal perspective, including relevant healthcare costs and parental productivity loss. Furthermore, a decision-analytic model is developed in which different levels of adherence are associated with clinical and financial outcomes. Also, sensitivity analyses are carried out on different price levels for RTMM. Discussion If RTMM with tailored text-message reminders proves to be effective, this technique can be used in daily practice, which would support children with suboptimal adherence in their asthma (self)management and in achieving better asthma control and better quality of life. Trial registration Netherlands Trial Register NTR2583 .
机译:背景技术许多哮喘儿童没有足够的哮喘控制能力,这导致医疗费用增加和父母的生产力损失。原因之一是依从性问题。因此,改善药物依从性的有效干预措施可能会改善哮喘控制并降低成本。一种有前途的解决方案是,当一种药物即将被遗忘时,通过手机网络发送实时文本消息。由于尚不清楚实时短信对哮喘儿童的影响,因此本研究的主要目的是确定带有短信的实时药物监测系统(RTMM)对吸入性糖皮质激素(ICS)依从性的影响。次要目标是研究RTMM对哮喘控制,生活质量和治疗成本效益的影响。方法一项多中心,随机对照试验,涉及使用ICS治疗哮喘的220名儿童(4-11岁)。所有儿童都将接受RTMM设备一年的服务,该设备记录ICS剂量的时间和日期。干预组中的儿童还收到量身定制的短信,仅在有遗漏剂量的危险时才发送。主要结果指标是在单独预定义的时间间隔内服用ICS剂量的比例。次要结果指标包括哮喘控制(每月哮喘控制测试),哮喘急性发作,医疗保健(从医院记录,患者报告和药房记录数据收集)以及特定疾病的生活质量(PAQLQ调查表)。父母和孩子对RTMM的接受程度通过在线焦点小组和患者问卷进行评估。从社会角度进行经济评估,包括相关的医疗保健费用和父母的生产力损失。此外,开发了决策分析模型,其中不同水平的依从性与临床和财务结果相关。此外,针对RTMM在不同的价格水平上进行敏感性分析。讨论如果RTMM带有量身定制的短信提醒功能被证明是有效的,则该技术可以用于日常实践中,这将支持哮喘(自我)管理欠佳的儿童,并更好地控制哮喘和改善生活质量。试用注册荷兰试用注册NTR2583。

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