TB PuRe : Pulmonary rehabilitation to reduce post-tuberculosis morbidity

TB PuRe ：肺康复可降低结核病后发病率

• 批准号: 10586385
• 负责人: JONATHAN E. GOLUB
• 金额: $ 68.24万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586385
• 关键词: Address; Adherence; Adoption; Adult; Aerobic; Behavioral; Characteristics; Chronic; Chronic lung disease; Client; Clinic; Clinic Visits; Clinical; Controlled Clinical Trials; Counseling; Data; Development; Disease; Education; Eligibility Determination; Enrollment; Ensure; Epidemiology; Excess Mortality; Funding; Geography; Goals; Health; Health system; Home; Impairment; India; Individual; Infrastructure; Intervention; Interview; Lung; Lung diseases; Measures; Monitor; Morbidity - disease rate; Natural History; Nature; Nutritional; Outcome Assessment; Participant; Patient-Focused Outcomes; Patients; Population; Process; Public Health; Pulmonary Tuberculosis; Randomized; Research; Resistance; Resource-limited setting; Resources; Site; Survivors; Target Populations; Testing; Training; Tuberculosis; United States National Institutes of Health; Walking; arm; budget impact; comparative effectiveness; cost; cost comparison; cost effective intervention; cost effectiveness; design; drug-sensitive; effective intervention; effectiveness evaluation; effectiveness measure; effectiveness outcome; effectiveness study; exercise capacity; functional disability; functional status; health care service utilization; health related quality of life; impaired functional status; implementation/effectiveness; improved; intervention delivery; lung health; lung injury; mortality risk; multidisciplinary; prevent; primary outcome; programs; pulmonary function; pulmonary rehabilitation; rehabilitation strategy; respiratory health; respiratory morbidity; scale up; secondary outcome; service delivery; service organization; societal costs; standard of care; success; telephone coaching; three-arm study; tuberculosis treatment

ABSTRACT The overarching goal of the Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PuRe) project is to measure the effectiveness, feasibility, and cost-effectiveness of a pulmonary rehabilitation (PR) program to prevent post-tuberculosis (TB) respiratory morbidity in India. TB is associated with lung impairment which can persist despite successful completion of TB treatment. There are an estimated 155 million TB survivors globally, yet there are no routinely implemented interventions for addressing post-TB respiratory morbidity. PR is a key component of the management plan for chronic lung diseases and is an effective intervention to improve patient- centered outcomes. However, the clinical benefit of PR, administered during TB treatment, in preventing post- TB respiratory morbidity has not been investigated. Furthermore, despite the long natural history of TB disease and its disproportionate impact in resource limited settings, the feasibility of a home-based PR program for TB patients is unclear. Therefore, the aims of TB PuRe are: a) to measure the comparative-effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity; b) to describe the intersection between clinic-level service organization, coach intervention delivery fidelity, and client behavioral action for these two PR programs; c) to compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program. To achieve these aims, 690 adult drug- sensitive pulmonary TB patients with functional impairment at TB treatment initiation will be enrolled at three geographically and epidemiologically diverse study sites in India. Participants will be randomized in 1:1:1 ratio into one of the following three study arms: a) 2 months of home-based PR during TB treatment (short PR arm); b) 2 months of home-based PR during TB treatment followed by 4 additional months of home-based PR for participants with persistent functional impairment despite 2 months of PR (extended PR arm); c) standard TB treatment without specific PR (standard-of-care arm). The primary outcome will be the 6-minute walk test distance compared between short and extended PR arms, and the standard-of-care arm at 12 months after randomization. We will assess the PR interventions' acceptability to inform adoption of the PR strategies in a programmatic setting by using the Theoretical Framework for Acceptability. Furthermore, we will empirically assess societal costs of the two PR programs at the patient-level, factoring the resource-use in the process of development of programmatic infrastructure, implementation, service delivery, and patient costs. Cost- effectiveness of the two programs will be assessed based on Health-related Quality of Life (HrQOL) outcomes assessment. Our study, if significant, will generate the strongest evidence to date to support routine implementation of a systematic PR program to reduce post-TB respiratory morbidity. Our multidisciplinary team with distinct, yet complementary, expertise and a strong track record of conducting NIH funded TB research in India will ensure the successful execution of the TB PuRe project.

摘要 肺康复以减少结核病后发病率项目的总体目标 是衡量肺康复（PR）计划的有效性、可行性和成本效益， 在印度预防结核病后呼吸道疾病。结核病与肺损伤有关， 尽管成功完成了结核病治疗，但仍持续存在。全球估计有1.55亿结核病幸存者， 然而，没有常规实施的干预措施来解决结核病后呼吸道疾病的发病率。PR是关键 是慢性肺部疾病管理计划的组成部分，是改善患者 以结果为中心。然而，在结核病治疗期间给予PR在预防结核病后复发方面的临床益处， 肺结核呼吸道疾病的发病率尚未调查。此外，尽管结核病的自然史很长， 及其在资源有限的环境中不成比例的影响，以家庭为基础的结核病公关计划的可行性 患者不清楚。因此，TB PuRe的目的是：a）衡量两种药物的比较有效性 在结核病治疗期间实施以家庭为基础的PR计划，以预防结核病后呼吸道疾病; B） 描述诊所级服务组织、教练干预交付保真度和客户之间的交叉点 这两个公关计划的行为行动; c）比较成本，成本效益和预算影响， 这两种不同的公关策略作为一个例行程序实施。为了实现这些目标，690名成人毒品- 在TB治疗开始时有功能损害的敏感性肺TB患者将在3个月后入组。 在印度的地理和流行病学上多样化的研究地点。参与者将以1：1：1的比例随机分配 a）在TB治疗期间进行2个月的基于家庭的PR（短PR组）; B）结核病治疗期间2个月的家庭PR，随后4个月的家庭PR， 尽管PR持续2个月，但仍有持续性功能障碍的参与者（延长PR组）; c）标准TB 无特异性PR的治疗（标准治疗组）。主要结果将是6分钟步行测试 短PR组和长PR组之间的距离比较，以及标准治疗组在术后12个月时的距离 随机化我们将评估公共关系干预措施的可接受性，以便为公共关系战略的采用提供信息， 通过使用可接受性的理论框架进行编程设置。此外，我们将根据经验 在患者层面评估这两个PR项目的社会成本，将资源使用因素考虑在内， 方案基础设施的开发、实施、服务交付和患者成本。费用- 将根据健康相关生活质量（HrQOL）结果评估这两个项目的有效性 考核我们的研究，如果重要的话，将产生迄今为止最有力的证据来支持常规治疗。 实施系统的公共关系方案，以减少结核病后呼吸道疾病的发病率。我们的多学科团队 具有独特但互补的专业知识和进行NIH资助的结核病研究的良好记录， 印度将确保结核病纯净项目的成功执行。