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