Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania
Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania
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DOI：
10.1186/s12874-016-0245-9
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发表时间：
2016-10-18
影响因子：
4
通讯作者：
Makani, Julie
中科院分区：
文献类型：
--
作者：
Makubi, Abel;Sasi, Philip;Makani, Julie
背景资料：已证明，羟基脲（HU）可有效减少镰状细胞性贫血（SCA）患者的并发症，但粘附性差是一个障碍。直接观察治疗（DOT）已被证明可以提高各种慢性疾病的依从性，但在成年人SCA.Methods和设计的数据有限：检查移动直接观察治疗（mDOT）对坚持HU（mDOT-HuA）在坦桑尼亚Muhimbili国家医院SCA的成年人的影响。mDOT-HuA研究是一项单中心、前瞻性、随机、开放标签临床试验。将纳入100名患有SCA且血红蛋白SS基因型、年龄≥ 18岁、居住在达累斯萨拉姆、能够并愿意以电子方式录制和提交视频的个人。受试者将被分为两个治疗组;标准监测（SM）组中的50名受试者将接受移动的电话和固定剂量HU治疗以及标准监测; mDOT组中的50名受试者将接受移动的电话、固定剂量HU治疗以及标准监测和移动的直接观察的基于网络的药物依从性监测系统。主要结局是通过3个月治疗结束时的药物持有率评估的两组之间实现>= 80%HU依从性的参与者比例。REDCap是一种开源软件应用程序，将用于使用临床研究表格收集数据。将通过Fisher精确检验比较两组的依从性比例。结果的分析将进行意向治疗和按协议的methods.Discussion：如果这项研究成为sucessful，它将有潜力的发展新的战略，提高HU坚持SCA。
Background: Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA) but poor adherence is a barrier. Directly Observed Therapy (DOT) has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA.Methods and design: To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged >= 18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM) arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving >= 80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher's exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods.Discussion: Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA.