Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial.
Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial.
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移动结核病治疗支持工具，以提高阿根廷结核病患者的治疗成功率：随机对照试验方案。
DOI：
10.2196/28094
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发表时间：
2021-06-21
影响因子：
1.7
通讯作者：
Rubinstein F
中科院分区：
文献类型：
--
作者：
Iribarren S;Milligan H;Goodwin K;Aguilar Vidrio OA;Chirico C;Telles H;Morelli D;Lutz B;Sprecher J;Rubinstein F
结核病是一个紧迫的全球健康威胁，也是世界上最致命的传染病，尽管它基本上是可以治愈的。一个关键的挑战是确保患者坚持全程治疗，以防止疾病的继续传播和耐药疾病的发展。流动卫生干预有望提供必要的坚持支持，以改善结核病治疗结果。本研究旨在评估结核病治疗支持工具(TB-TSTs)干预对治疗结果(成功和默认)的有效性，并评估患者和提供者对促进者和实施TB-TSTs的障碍的看法。TB-TSTs研究是一项开放标签的随机对照试验，有两组平行试验，其中400名新诊断为结核病的成年患者将被随机分配到接受常规护理或常规护理加TB-TSTs。参与者将从阿根廷的4个临床地点滚动招募。干预措施包括一个智能手机进步网络应用程序，一个治疗支持者(例如，结核病护士、医生或社会工作者)，以及一个专为家庭使用而设计的直接依从性测试试纸。干预组参与者将报告治疗进展，并使用APP和代谢物尿检纸条与治疗支持者互动。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。我们将评估患者和提供者对实施障碍的看法，并综合经验教训。我们假设，TB-TSTS干预将更加有效，因为它允许患者和结核病支持者实时监测和解决问题，并提供量身定制的支持。我们将与利益相关者和政策制定者分享结果。招生于2020年11月开始，由于新冠肺炎疫情推迟了开始，预计大约在2022年7月完成招生。数据收集和随访预计在最后一名患者入选后6个月完成。基于主要终点的分析结果预计将在数据收集完成后一年内提交出版。据我们所知，这项随机对照试验将是第一次使用移动工具和家庭直接药物代谢物测试来评估以患者为中心的远程治疗支持策略的研究。这一结果将为移动卫生工具的有效性、实施和采用提供强有力的科学证据。这些发现不仅对结核病的坚持有更广泛的影响，而且对慢性病管理也有更广泛的影响，并将提高我们对如何支持面临挑战的治疗方案的患者的理解。ClinicalTrials.gov NCT04221789；https://clinicaltrials.gov/ct2/show/NCT04221789.DERR1-10.2196/28094
Tuberculosis (TB) is an urgent global health threat and the world’s deadliest infectious disease despite being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of the disease and development of drug-resistant disease. Mobile health interventions hold promise to provide the required adherence support to improve TB treatment outcomes. This study aims to evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success and default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TSTs implementation. The TB-TSTs study is an open-label, randomized controlled trial with 2 parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Participants will be recruited on a rolling basis from 4 clinical sites in Argentina. The intervention consists of a smartphone progressive web app, a treatment supporter (eg, TB nurse, physician, or social worker), and a direct adherence test strip engineered for home use. Intervention group participants will report treatment progress and interact with a treatment supporter using the app and metabolite urine test strip. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patients’ and providers’ perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share the results with stakeholders and policy makers. Enrollment began in November 2020, with a delayed start due to the COVID-19 pandemic, and complete enrollment is expected by approximately July 2022. Data collection and follow-up are expected to be completed 6 months after the last patient is enrolled. Results from the analyses based on the primary end points are expected to be submitted for publication within a year of data collection completion. To our knowledge, this randomized controlled trial will be the first study to evaluate a patient-centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on the effectiveness, implementation, and adoption of mobile health tools. The findings have broader implications not only for TB adherence but also more generally for chronic disease management and will improve our understanding of how to support patients facing challenging treatment regimens. ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789. DERR1-10.2196/28094
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影响因子：
5
作者：
Iribarren SJ;Schnall R;Stone PW;Carballo-Diéguez A
通讯作者：
Carballo-Diéguez A
影响因子：
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作者：
Iribarren SJ;Rubinstein F;Discacciati V;Pearce PF
通讯作者：
Pearce PF
影响因子：
5.5
作者：
Hoffman, Jeffrey A.;Cunningham, Janice R.;Hunt-Glassman, Jonathan
通讯作者：
Hunt-Glassman, Jonathan
影响因子：
3.7
作者：
Belknap R;Weis S;Brookens A;Au-Yeung KY;Moon G;DiCarlo L;Reves R
通讯作者：
Reves R
影响因子：
4.5
作者：
Hirpa S;Medhin G;Girma B;Melese M;Mekonen A;Suarez P;Ameni G
通讯作者：
Ameni G