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.

抽象的 降低结核病后发病率的肺康复 (TB PuRe) 项目的总体目标 旨在衡量肺康复 (PR) 计划的有效性、可行性和成本效益 预防印度结核病后呼吸道疾病。结核病与肺损伤有关，可 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，尚无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。公关是关键 慢性肺病管理计划的组成部分，是改善患者健康状况的有效干预措施 以结果为中心。然而，在结核病治疗期间进行 PR 在预防结核病后复发方面具有临床益处。 结核病呼吸道发病率尚未进行调查。此外，尽管结核病自然史很长 及其在资源有限环境中的不成比例的影响，结核病家庭公关计划的可行性 患者不清楚。因此，TB PuRe 的目标是： a) 衡量两种药物的比较有效性 在结核病治疗期间实施的家庭 PR 计划，以预防结核病后呼吸道疾病的发病； b) 到 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 作为常规计划实施的两种不同的公关策略。第 690 章 结核病治疗开始时有功能障碍的敏感肺结核患者将在三点入组 印度具有地理和流行病学多样性的研究地点。参与者将以 1:1:1 的比例随机分配 分为以下三个研究组之一： a) 结核病治疗期间 2 个月的家庭 PR（短期 PR 组）； b) 结核病治疗期间进行 2 个月的家庭 PR，随后再进行 4 个月的家庭 PR 尽管进行了 2 个月的 PR（延长 PR 臂），但仍存在持续功能障碍的参与者； c) 标准结核病 没有特定 PR 的治疗（标准护理组）。主要结果是 6 分钟步行测试 术后 12 个月时短 PR 臂和长 PR 臂之间的距离以及标准护理臂之间的距离比较 随机化。我们将评估公关干预措施的可接受性，以便为公关策略的采用提供信息 通过使用可接受性理论框架进行编程设置。此外，我们将根据经验 评估两个 PR 项目在患者层面的社会成本，考虑过程中的资源使用 规划基础设施的开发、实施、服务提供和患者成本。成本- 这两个计划的有效性将根据健康相关的生活质量 (HrQOL) 结果进行评估 评估。我们的研究如果有意义的话，将产生迄今为止最有力的证据来支持常规 实施系统性 PR 计划以减少结核病后呼吸道疾病发病率。我们的多学科团队 拥有独特但互补的专业知识，并在 NIH 资助的结核病研究方面拥有良好的记录 印度将确保TB PuRe项目的成功实施。