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Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial

机译:慢性阻塞性肺疾病中基于家庭的肺部康复的收益和成本-一项多中心随机对照试验

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Background Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease (COPD) to improve exercise capacity, symptoms and quality of life, however only a minority of individuals with COPD are able to participate. Travel and transport are frequently cited as barriers to uptake of centre-based programs. Other models of pulmonary rehabilitation, including home-based programs, have been proposed in order to improve access to this important treatment. Previous studies of home-based pulmonary rehabilitation in COPD have demonstrated improvement in exercise capacity and quality of life, but not all elements of the program were conducted in the home environment. It is uncertain whether a pulmonary rehabilitation program delivered in its entirety at home is cost effective and equally capable of producing benefits in exercise capacity, symptoms and quality of life as a hospital-based program. The aim of this study is to compare the costs and benefits of home-based and hospital-based pulmonary rehabilitation for people with COPD. Methods/Design This randomised, controlled, equivalence trial conducted at two centres will recruit 166 individuals with spirometrically confirmed COPD. Participants will be randomly allocated to hospital-based or home-based pulmonary rehabilitation. Hospital programs will follow the traditional outpatient model consisting of twice weekly supervised exercise training and education for eight weeks. Home-based programs will involve one home visit followed by seven weekly telephone calls, using a motivational interviewing approach to enhance exercise participation and facilitate self management. The primary outcome is change in 6-minute walk distance immediately following intervention. Measurements of exercise capacity, physical activity, symptoms and quality of life will be taken at baseline, immediately following the intervention and at 12 months, by a blinded assessor. Completion rates will be compared between programs. Direct healthcare costs and indirect (patient-related) costs will be measured to compare the cost-effectiveness of each program. Discussion This trial will identify whether home-based pulmonary rehabilitation can deliver equivalent benefits to centre-based pulmonary rehabilitation in a cost effective manner. The results of this study will contribute new knowledge regarding alternative models of pulmonary rehabilitation and will inform pulmonary rehabilitation guidelines for COPD. Trial registration ClinicalTrials.gov: NCT01423227 .
机译:背景技术慢性阻塞性肺疾病(COPD)的患者广泛倡导肺康复,以改善运动能力,症状和生活质量,但是只有少数COPD患者能够参加。人们经常提到旅行和运输是采用中心课程的障碍。为了改善获得这种重要治疗方法的可能性,已经提出了其他的肺康复模型,包括基于家庭的计划。先前对COPD进行的基于家庭的肺部康复的研究表明,运动能力和生活质量得到改善,但并非该计划的所有要素都在家庭环境中进行。尚不确定在家中全面实施的肺康复计划是否具有成本效益,是否有能力像医院计划一样在运动能力,症状和生活质量方面产生益处。这项研究的目的是比较COPD患者在家和医院进行肺部康复的成本和收益。方法/设计这项在两个中心进行的随机,对照,当量试验将招募166名经肺活量测定证实为COPD的患者。参与者将被随机分配到医院或家庭进行的肺部康复。医院计划将遵循传统的门诊模式,包括每周两次的监督运动训练和为期八周的教育。以家庭为基础的计划将包括一次家访,然后每周进行七个电话通话,采用激励性访谈方法来增强锻炼参与度并促进自我管理。主要结果是干预后6分钟步行距离发生变化。运动能力,身体活动,症状和生活质量的测量将在基线时,干预后立即进行,并在12个月时由盲人评估者进行。完成率将在程序之间进行比较。将衡量直接医疗保健成本和间接(与患者相关的)成本,以比较每个计划的成本效益。讨论该试验将确定以家庭为基础的肺部康复是否可以以成本有效的方式与以中心为基础的肺部康复等效。这项研究的结果将为有关肺康复的替代模型提供新知识,并将为COPD的肺康复指南提供依据。试用注册ClinicalTrials.gov:NCT01423227。

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