Lung Health Research Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi
UCL GOS Institute of Child Health, University College London, London, UK.
BMJ Open. 2022 Jan 31;12(1):e057538. doi: 10.1136/bmjopen-2021-057538.
INTRODUCTION: Malawi has a substantial burden of chronic respiratory diseases (CRDs) which cause significant morbidity and loss of economic productivity, affecting patients, families and health systems. Pulmonary rehabilitation (PR) is a highly recommended non-pharmacological intervention in the clinical management of people with CRDs. However, Malawi lacks published evidence on the implementation of PR for people with CRDs. This trial will test the feasibility and acceptability of implementing a culturally appropriate hospital-based PR programme among adults with functionally limiting CRDs at Queen Elizabeth Central Hospital in Blantyre, Malawi. METHODS AND ANALYSIS: This is a single-centre mixed-methods pre-post single-arm feasibility trial. Ten patients aged ≥18 years, with a spirometry confirmed diagnosis of a CRD and breathlessness of ≥2 on the modified Medical Research Council dyspnoea scale, will be consecutively recruited. Their baseline lung function, exercise tolerance and health status will be assessed; including spirometry, Incremental Shuttle Walk Test and Chronic Obstructive Pulmonary Disease Assessment Test, respectively. Pretrial semistructured in-depth interviews will explore their experiences of living with CRD and potential enablers and barriers to their PR uptake. Along with international PR guidelines, these data will inform culturally appropriate delivery of PR. We initially propose a 6-week, twice-weekly, supervised centre-based PR programme, with an additional weekly home-based non-supervised session. Using combination of researcher observation, interaction with the participants, field notes and informal interviews with the participants, we will assess the feasibility of running the programme in the following areas: participants' recruitment, retention, engagement and protocol adherence. Following programme completion (after 6 weeks), repeat assessments of lung function, exercise tolerance and health status will be conducted. Quantitative changes in clinical outcomes will be described in relation to published minimal clinically important differences. Post-trial semistructured interviews will capture participants' perceived impact of the PR programme on their quality of life, enablers, and barriers to fully engaging with the programme, and allow iteration of its design. ETHICS AND DISSEMINATION: Ethical approval for this trial was obtained from University of Malawi College of Medicine Research and Ethics Committee (COMREC), Blantyre, Malawi (protocol number: P.07/19/2752) and University of Leicester Research Ethics Committee, Leicester, UK (ethics reference: 31574). The results of the trial will be disseminated through oral presentations at local and international scientific conferences or seminars and publication in a peer-reviewed journal. We will also engage the participants who complete the PR trial and the Science Communication Department at Malawi-Liverpool-Wellcome Trust Clinical Research Programme to organise community outreach activities within Blantyre to educate communities about CRDs and PR. We will also broadcast our trial results through national radio station programmes such as the weekly "Thanzi la Onse" (Health of All) programme by Times Radio Malawi. We will formally present our trial results to Blantyre District Health Office and Malawi Ministry of Health. TRIAL REGISTRATION NUMBER: ISRCTN13836793.
简介:马拉维有大量的慢性呼吸道疾病(CRD)负担,这些疾病导致了相当大的发病率和经济生产力的丧失,影响了患者、家庭和卫生系统。肺康复(PR)是临床管理 CRD 患者的一种高度推荐的非药物干预措施。然而,马拉维缺乏关于在马拉维布兰太尔伊丽莎白女王中央医院为 CRD 患者实施 PR 的实施情况的已发表证据。本试验将测试在马拉维布兰太尔伊丽莎白女王中央医院对功能受限的 CRD 成人实施文化上适当的基于医院的 PR 方案的可行性和可接受性。
方法和分析:这是一项单中心混合方法前后单臂可行性试验。将连续招募 10 名年龄≥18 岁、经肺量计确诊为 CRD 和改良医学研究委员会呼吸困难量表呼吸困难程度≥2 的患者。将评估他们的基线肺功能、运动耐量和健康状况;包括肺量计、递增穿梭步行试验和慢性阻塞性肺疾病评估测试。术前半结构深入访谈将探讨他们与 CRD 共存的经验以及他们接受 PR 的潜在促进因素和障碍。根据国际 PR 指南,这些数据将为 PR 的文化适应性提供信息。我们最初提出了一个 6 周、每周两次、监督的基于中心的 PR 方案,外加每周一次的非监督家庭方案。我们将使用研究人员观察、与参与者互动、现场记录和对参与者的非正式访谈相结合,评估以下方面的方案运行可行性:参与者的招募、保留、参与和方案依从性。在方案完成后(6 周后),将重复进行肺功能、运动耐量和健康状况评估。将描述临床结局的定量变化与已发表的最小临床重要差异相关。术后半结构访谈将捕获参与者对 PR 方案对其生活质量的感知影响、促进因素以及充分参与方案的障碍,并允许对其设计进行迭代。
伦理和传播:该试验的伦理批准获得了马拉维大学医学院研究和伦理委员会(COMREC)、布兰太尔(批准号:P.07/19/2752)和莱斯特大学伦理委员会的批准,英国(伦理参考:31574)。试验结果将通过在当地和国际科学会议上的口头报告或研讨会以及在同行评议的期刊上发表来传播。我们还将与完成 PR 试验的参与者以及马拉维-利物浦-惠康信托临床研究计划的科学传播部门合作,在布兰太尔组织社区外展活动,向社区宣传 CRD 和 PR。我们还将通过国家广播电台节目,如 Times Radio Malawi 的每周“Thanzi la Onse”(全民健康)节目,播放我们的试验结果。我们将正式向布兰太尔地区卫生办公室和马拉维卫生部提交我们的试验结果。
试验注册:ISRCTN84055437。
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