结核病治疗支持工具交互式移动应用程序和对结核病治疗结果的直接依从性监测 (TB-TST)
2024年4月17日 更新者：Institute for Clinical Effectiveness and Health Policy
结核病治疗支持工具：交互式移动应用程序的改进和评估以及对结核病治疗结果的直接依从性监测
本研究的总体目标是进行随机临床试验 (RCT) 以评估结核病治疗支持工具 (TB-TST)、使用以用户为中心的设计原则开发的手机应用程序和纸质药物代谢物尿液试纸修改为家庭使用，用于测试尿液中异烟肼药物代谢物的存在，以直接监测治疗的依从性，以改善接受自我管理治疗 (SAT) 的结核病患者的治疗结果。
结核病治疗方案的药物依从性差，以及监测患者和让他们重返治疗的挑战，是导致不良结果和耐药性发展的重要因素。 随着移动技术平台的进步和扩散，人们对可能使用移动健康 (mHealth) 干预措施来应对这些挑战产生了浓厚的兴趣。 在正在研究的用于 TB 依从性监测的 mHealth 方法中，药物代谢物检测已被确定为最有前途、合乎道德、最准确，与其他移动解决方案相比侵入性和污名化最少的策略，但其潜力在很大程度上仍未被开发。 此外，移动应用程序 (app) 可以提供个性化的治疗监督，增加患者的自我管理，并通过为患者支持和监测提供更高级的功能来改善患者与提供者的沟通。
现有版本的 TB-TST 应用程序提供有关结核病及其治疗的教育、与护理协调员的沟通、跟踪治疗依从性（通过自我报告和直接代谢物试纸图像）、自我报告治疗副作用，以及保留患者的“日记”笔记。 该提案建立在以下初步工作的基础上：1) 根据试点研究结果改进 TB-TST 干预并应用以用户为中心的设计原则； 2) 与常规护理相比，评估 TB-TST 对治疗结果的影响； 3) 评估患者和提供者对实施 TB-TST 的促进者和障碍的看法，并综合利益相关者和政策制定者的经验教训。 主要结果将是治疗成功。 次要结果将包括：治疗违约率、自我报告的依从性、技术使用和可用性。 研究结果不仅对结核病依从性有更广泛的影响，而且对更普遍的疾病管理具有更广泛的意义，并将提高我们对如何支持面临挑战性治疗方案的患者的理解
研究概览
详细说明
尽管结核病在很大程度上可以治愈，但它仍然是全球十大死亡原因之一。
患者在坚持治疗方面面临许多挑战，而移动健康 (mHealth) 干预措施可以解决这些挑战并支持患者完成治疗。
我们将根据患者和结核病专家的综合意见改进交互式干预，并在随机临床试验中评估干预对治疗结果的影响。
研究结果不仅对结核病依从性有更广泛的意义，而且对更普遍的疾病管理具有更广泛的意义，并将提高我们对如何支持患者接受具有挑战性的治疗方案的理解。
研究类型
介入性
注册 (实际的)
555
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fernando A Rubinstein, MD MPH
- 电话号码：+54 11 47778767
- 邮箱：frubinstein@iecs.org.ar
研究联系人备份
- 姓名：Sarah Iribarren, RN PhD
- 电话号码：206 543 5211
- 邮箱：sjiribar@uw.edu
学习地点
-
-
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Buenos Aires、阿根廷、1414
- IECS
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 65年 (孩子、成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 参与者必须年满 16 岁，
- 新诊断为药物敏感结核病，
- 第一次治疗
- 可以经常使用智能手机，并且
- 能够操作电话或有人能够协助。
排除标准：
- 15 岁以下的儿童
- 重新治疗（默认或先前治疗失败）
- 病情严重的患者（即需要住院治疗）
- 与另一名研究参与者住在同一家庭的患者
- 无法操作智能手机
- 文盲（无法读写）
- 已知耐药的患者
- 已知同时感染 HIV 的患者将被排除在外，因为他们的护理是分开管理的。
- 筛选后不符合研究资格的患者将特定筛选数据（包括性别、年龄和排除原因）输入研究数据库，以检查排除原因和入组标准的可行性。
病例定义：至少 16 岁的结核病患者，痰涂片阳性或根据放射学发现和临床体征和症状诊断为肺结核，但痰涂片阴性。 可以通过其他方法确认诊断，例如 MGIT960、BACTEC 9000 或 MB Bact、核酸扩增 (PCR) 或 ELISA。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：干预：结核病治疗助理
患者收到使用电话应用程序的说明
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支持自我管理治疗和监测依从性的手机应用程序
其他名称：
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无干预：控制
接受常规护理自我管理治疗说明的患者
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
治疗成功
大体时间：6个月
|
完成治疗和/或治愈
|
6个月
|
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治疗违约
大体时间：6个月
|
放弃治疗至少2个月
|
6个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Fernando A Rubinstein, MD MPH、Institute for Clinical Effectiveness and Health Policy
- 首席研究员：Sarah Iribarren, RN PhD、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年11月17日
初级完成 (实际的)
2023年12月31日
研究完成 (估计的)
2024年6月1日
研究注册日期
首次提交
2020年1月6日
首先提交符合 QC 标准的
2020年1月6日
首次发布 (实际的)
2020年1月9日
研究记录更新
最后更新发布 (实际的)
2024年4月18日
上次提交的符合 QC 标准的更新
2024年4月17日
最后验证
2024年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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