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）：估计世界上三分之一的人口感染结核分枝杆菌，每年导致 920 万例结核病 (TB) 病例和 220 万人死亡。如果没有良好地遵守持续 6 个月的治疗方案，疾病就会进展，患者仍然具有传染性，并且会形成突变，使细菌对抗结核药物产生耐药性。依从性差对个人和社区层面的影响如此之大，以至于世界各地的卫生机构建议，只要可行，就应观察患者服用每剂药物的情况，称为直接观察治疗（DOT）。然而，DOT 是资源密集型的，对患者有限制，并且对于居住地远离 DOT 提供者的患者来说无法使用。本研究的目的是开发并试点测试一种灵活且经济高效的方法，通过视频手机提供远程 DOT，患者将使用该方法拍摄自己服用药物的视频，并将视频传输给 DOT 工作人员进行审查。视频手机 DOT (VCP-DOT) 的优点包括可以随时随地拍摄视频，并且 DOT 工作人员可以通过在方便时查看视频来管理更大的案件量。我们的长期目标是为发达国家和发展中国家的结核病控制项目提供有效治疗结核病的改进方法。这项探索性/发展性 R21 研究的目的是： 1) 确定患者和提供者之间 VCP-DOT 交付的可改变的障碍和促进因素； 2) 确定 VCP-DOT 的可接受性和可行性，并估计与面对面 DOT 相比的治疗依从率； 3) 描述患者使用 VCP-DOT 的体验，以确定可能影响依从性和患者满意度的计划组成部分。我们假设 VCP-DOT 是患者可以接受的，并且比面对面 DOT 更能以更低的成本实现更高的治疗依从性。为了实现这些目标，我们将开展一系列焦点小组活动，以确定结核病医疗保健提供者和患者对 VCP-DOT 的促进因素和障碍。焦点小组将首先在圣地亚哥进行，以确定主要主题，然后在蒂华纳进行，以确定文化和特定环境的差异。这些信息将用于微调干预措施，然后在圣地亚哥的 40 名患者和蒂华纳的 10 名患者中进行试点测试，以评估其与现有 DOT 计划相比的可行性、可接受性、成本和潜在功效。试点还可能揭示干预措施的技术优势和劣势。研究结果将用于提出一项足够有力的随机对照试验，以测试 VCP-DOT 在国际环境中的功效和成本效益。这项研究将在美国/墨西哥边境城市圣地亚哥和蒂华纳进行，因为这两个城市的结核病发病率高且距离近，使我们能够在结核病控制系统截然不同的两个地区经济有效地开发和试点测试 VCP-DOT。如果有效，VCP-DOT 可以显着减轻患者及其提供者的结核病治疗负担和费用，从而提高治疗依从性并扩大全球治疗选择，包括那些无法亲自接受 DOT 治疗的患者。 公共卫生相关性：在结核病治疗持续时间从目前的 6 个多月大幅缩短之前，需要新的方法来经济有效地确保高水平的治疗依从性，以治愈患者并避免产生抗结核药物耐药性。这项探索性/发展性研究将评估使用可摄像手机提供直接观察的结核病治疗。这项研究响应了美国联邦结核病工作组的建议，即“通过行为研究确定当前使用的治疗方案的替代方案和辅助手段，以提高对治疗的依从性（国内和国际）”。