Mobile Phone-Based Video Directly Observed Therapy for Tuberculosis

结核病手机视频直观治疗

• 批准号: 7878280
• 负责人: Richard S Garfein
• 金额: $ 23.47万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7878280
• 关键词: Address; Adherence; Advisory Committees; Antitubercular Agents; Area; Behavioral Research; Car Phone; Cellular Phone; Cessation of life; Cities; Client satisfaction; Communities; Developing Countries; Development; Directly Observed Therapy; Dose; Drug resistance; Focus Groups; Goals; Health; Health Personnel; Incidence; Individual; International; Intervention; Life; Location; Methods; Mexico; Mutation; Mycobacterium tuberculosis; Patients; Persons; Pharmaceutical Preparations; Population; Provider; Randomized Controlled Trials; Recommendation; Resources; Series; System; Testing; Time; Treatment Protocols; Tuberculosis; bacterial resistance; base; comparative efficacy; cost; cost effectiveness; efficacy testing; experience; flexibility; improved; novel; programs; public health relevance; research study; treatment adherence; treatment duration; tuberculosis drugs; tuberculosis treatment

DESCRIPTION (provided by applicant): An estimated one-third of the world's population is infected with M. tuberculosis, resulting in 9.2 million cases of tuberculosis (TB) and 2.2 million deaths annually. Without good compliance with treatment regimens lasting =6 months, illness progresses, patients remain contagious, and mutations form rendering the bacteria resistant to anti-TB medications. So great are the individual and community level impacts of poor adherence that health agencies worldwide recommend that, whenever feasible, patients should be observed taking each dose of medication, referred to as directly observed therapy (DOT). However, DOT is resource intensive, restrictive to patients, and unavailable to patients who live far from DOT providers. The purpose of this study is to develop and pilot test a flexible and cost-effective method of providing remote DOT via video cellular phones, which patients will use to video themselves taking their medications and transfer the videos to DOT workers for review. Advantages of video cell phone DOT (VCP-DOT) include the fact that videos can be taken from any location at any time and DOT workers can manage larger case loads by reviewing videos at their convenience. Our long term goal is to provide TB control programs in developed and developing countries with improved methods of effectively treating TB. The aims of this Exploratory/Developmental R21 research study are to; 1) identify modifiable barriers and facilitators to VCP-DOT delivery among patients and providers; 2) determine the acceptability and feasibility of VCP-DOT and estimate treatment adherence rates compared to in-person DOT; and 3) characterize patient experiences with VCP-DOT to identify program components that could impact adherence and patient satisfaction. We hypothesize that VCP-DOT is acceptable to patients and achieves greater treatment adherence at a lower cost than in-person DOT. To address these aims we will conduct a series of focus groups to identify facilitators and barriers to VCP-DOT elicited from TB healthcare providers and patients. Focus groups will first be conducted in San Diego to identify major themes, and then in Tijuana to identify cultural and setting-specific differences. This information will be used to fine-tune the intervention before it is pilot tested among 40 patients in San Diego and 10 patients in Tijuana to assess its feasibility, acceptability, cost and potential efficacy compared to existing DOT programs. The pilot might also reveal technical strengths and weaknesses of the intervention. Findings will be used to propose a sufficiently powered randomized controlled trial to test the efficacy and cost-effectiveness of VCP-DOT in international settings. This study will take place in the US/Mexico border cities of San Diego and Tijuana, because their high TB incidence rates and close proximity allow us to cost-effectively develop and pilot test VCP-DOT in two areas with vastly different TB control systems. If effective, VCP-DOT could dramatically reduce the burden and cost of TB treatment to patients and their providers, thereby increasing treatment adherence and expanding treatment options globally including among patients who live beyond the reach of in-person DOT. PUBLIC HEALTH RELEVANCE: Until TB treatment duration is significantly reduced from the current 6-plus months, novel methods are needed to cost-effectively assure high levels of treatment adherence to cure the patient and avoid development of anti- TB drug resistance. This Exploratory/Developmental study will evaluate the use of video-camera cell phones to deliver directly observed TB therapy. This study is responsive to the U.S. Federal TB Task Force's recommendation for "identifying alternatives and adjuncts to currently used treatment protocols through behavioral research to improve adherence to therapy (domestic and international)".

描述（由申请人提供）：估计世界人口的三分之一感染了结核分枝杆菌，每年有920万例结核病病例（TB）和220万例死亡。如果没有良好的治疗方案持续= 6个月，疾病进展，患者仍然具有传染性，并形成突变，从而使细菌具有抗抗TB药物的抗性。个人和社区水平的依从性较差的影响如此之大，以至于全球卫生机构建议，每当服用每种药物剂量的药物时，应观察到患者，被称为直接观察到的治疗（DOT）。但是，DOT是资源密集的，对患者的限制，并且对远离DOT提供者的患者无法使用。这项研究的目的是开发和试点测试一种通过视频蜂窝电话提供远程点的灵活且具有成本效益的方法，该方法将使用该方法来视频视频，并将视频转移到DOT工人中进行审查。视频手机点（VCP点）的优点包括一个事实，即可以随时从任何位置拍摄视频，而点工人可以通过方便地查看视频来管理更大的案例负载。我们的长期目标是在发达国家和发展中国家提供有效治疗结核病的方法。这项探索性/发展性R21研究的目的是； 1）确定可修改的障碍和促进因素，以使患者和提供者之间的VCP点输送； 2）确定与面对面点相比，VCP点和估计治疗依从性的可接受性和可行性； 3）表征患者使用VCP点的体验，以识别可能影响依从性和患者满意度的程序组件。我们假设患者可以接受VCP点，并且以比亲自点更低的成本获得更高的治疗依从性。为了解决这些目标，我们将进行一系列焦点小组，以识别TB医疗保健提供者和患者引起的VCP点的促进者和障碍。焦点小组将首先在圣地亚哥进行，以识别主要主题，然后在蒂华纳（Tijuana）识别文化和环境特定的差异。与现有的DOT计划相比，该信息将用于在圣地亚哥的40名患者和蒂华纳的10名患者中进行试点测试，以评估其可行性，可接受性，成本和潜在疗效，以调整干预措施。飞行员还可能揭示干预的技术优势和劣势。调查结果将用于提出一项足够动力的随机对照试验，以测试VCP点在国际环境中的功效和成本效益。这项研究将在美国/墨西哥边境城市的圣地亚哥和蒂华纳边境城市进行，因为它们的高结核病发生率和近距离接近，使我们能够在具有不同TB控制系统的两个领域进行成本效益开发和试点测试VCP点。如果有效，VCP点可能会大大减轻患者及其提供者的结核病治疗负担和成本，从而增加治疗依从性并在全球范围内扩大治疗方案，包括在超越亲自点触及的患者中。 公共卫生相关性：直到目前6个以上的结核病治疗持续时间大大减少之前，需要采用新颖的方法来成本效率地确保高水平的治疗依从性以治愈患者并避免发展抗TB耐药性。这项探索性/发展研究将评估视频相机手机的使用直接观察到的结核病治疗。这项研究对美国联邦结核病工作组的建议敏感，以“确定目前通过行为研究使用治疗方案来提高对治疗（国内和国际）的依从性的建议”。