Reilly Charles C, Maddocks Matthew, Chalder Trudie, Bristowe Katherine, Higginson Irene J
Department of Physiotherapy, King's College Hospital, London, UK.
Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, UK.
ERJ Open Res. 2023 Apr 11;9(2). doi: 10.1183/23120541.00508-2022. eCollection 2023 Mar.
SELF-BREATHE is a complex, transdiagnostic, supportive, digital breathlessness intervention co-developed with patients. SELF-BREATHE seeks to build capacity and resilience within health services by improving the lives of people with chronic breathlessness using nonpharmacological, self-management approaches. This study aimed to determine whether SELF-BREATHE is feasible to deliver and acceptable to patients living with chronic breathlessness.
A parallel, two-arm, single-blind, single-centre, randomised controlled, mixed-methods feasibility trial with participants allocated to 1) intervention group (SELF-BREATHE) or 2) control group (usual National Health Service (NHS) care). The setting was a large multisite NHS foundation trust in south-east London, UK. The participants were patients living with chronic breathlessness due to advanced malignant or nonmalignant disease(s). Participants were randomly allocated (1:1) to an online, self-guided, breathlessness supportive intervention (SELF-BREATHE) and usual care or usual care alone, over 6 weeks. The progression criteria were ≥30% of eligible patients given an information sheet consented to participate; ≥60% of participants logged on and accessed SELF-BREATHE within 2 weeks; and ≥70% of patients reported the methodology and intervention as acceptable.
Between January 2021 and January 2022, 52 (47%) out of 110 eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19 (73%) out of 26 logged on and used SELF-BREATHE for a mean±sd (range) 9±8 (1-33) times over 6 weeks. 36 (70%) of the 52 randomised participants completed and returned the end-of-study postal questionnaires. SELF-BREATHE users reported it to be acceptable. Post-intervention qualitative interviews demonstrated that SELF-BREATHE was acceptable and valued by users, improving breathlessness during daily life and at points of breathlessness crisis.
These data support the feasibility of moving to a fully powered, randomised controlled efficacy trial with minor modifications to minimise missing data ( multiple methods of data collection: face-to-face, telephone, video assessment and by post).
SELF-BREATHE是一项与患者共同开发的复杂的、跨诊断的、支持性的数字呼吸困难干预措施。SELF-BREATHE旨在通过采用非药物自我管理方法改善慢性呼吸困难患者的生活,从而增强医疗服务体系的能力和恢复力。本研究旨在确定SELF-BREATHE对于慢性呼吸困难患者是否可行且患者是否能够接受。
这是一项平行双臂、单盲、单中心随机对照混合方法可行性试验,参与者被分配至1)干预组(SELF-BREATHE)或2)对照组(英国国家医疗服务体系(NHS)常规护理)。研究地点为英国伦敦东南部一家大型多院区NHS基金会信托机构。参与者为因晚期恶性或非恶性疾病导致慢性呼吸困难的患者。参与者被随机分配(1:1)接受为期6周的在线自我引导呼吸困难支持干预(SELF-BREATHE)及常规护理或仅接受常规护理。纳入标准为:≥30%的符合条件且收到信息表的患者同意参与;≥60%的参与者在2周内登录并使用SELF-BREATHE;≥70%的患者认为该方法和干预措施可接受。
2021年1月至2022年1月期间,110名符合条件的患者中有52名(47%)同意参与并被随机分组。在被随机分配至SELF-BREATHE组的26名患者中,有19名(73%)在6周内登录并使用了SELF-BREATHE,平均使用次数±标准差(范围)为9±8(1 - 33)次。52名随机分组的参与者中有36名(70%)完成并返还了研究结束时的邮寄问卷。SELF-BREATHE的使用者表示该干预措施可接受。干预后的定性访谈表明,SELF-BREATHE被使用者接受并重视,改善了日常生活中的呼吸困难以及呼吸困难危机时刻的症状。
这些数据支持开展一项全面的随机对照疗效试验的可行性,只需进行微小修改以尽量减少数据缺失(采用多种数据收集方法:面对面、电话、视频评估和邮寄)。