Ennis Stuart, Heine Peter, Sandhu Harbinder, Sheehan Bart, Yeung Joyce, McWilliams David, Jones Christina, Abraham Charles, Underwood Martin, Bruce Julie, Seers Kate, McGregor Gordon
Clinical Trials Unit, University of Warwick, Coventry, UK.
Cardiopulmonary Rehabilitation, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.
NIHR Open Res. 2023 Jul 14;3:10. doi: 10.3310/nihropenres.13371.2. eCollection 2023.
Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge.
Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions.
The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos.
The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID.
International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.
感染新冠病毒而住院的患者中,多达一半的人报告称出现了各种持续症状,这些症状在出院后数月甚至数年都影响着他们的生活质量(即长期新冠症状)。我们描述了一种在线团体运动和行为支持干预措施的开发过程,该干预措施针对出院后三个多月仍持续存在此类身体和/或情绪健康问题的人群。
干预措施的开发参考了医学研究理事会关于复杂干预措施的框架。我们由学者、临床医生和患有长期新冠症状的人员组成的多学科团队,在复杂干预措施的开发和测试方面拥有集体专业知识。我们借鉴了针对长期健康状况的康复文献以及前期预试验研究的经验,整合了生物 - 心理 - 社会护理模式。为完善该干预措施召开了多次利益相关者会议,该干预措施旨在英国国家医疗服务体系内实施。我们遵循TIDieR指南,以透明且明确的方式报告远程医疗干预措施。
最终的REGAIN在线运动和行为支持干预措施包括与一名经过培训的从业者进行初始一对一咨询,随后是八次在线团体运动课程以及六次为期八周的团体支持课程。参与者还可以访问一个包含按需提供的运动和支持视频的在线图书馆。
最终的REGAIN干预措施将运动和行为支持相结合,已完全形成手册,具有清晰的实施和执行路径。目前正在一项随机对照试验中进行测试。该干预措施在患者和利益相关者的广泛参与下开发而成,如果被证明对患有长期新冠症状的人具有临床和成本效益,可纳入现有的英国国家医疗服务体系康复计划。
国际标准随机对照试验编号(ISRCTN)11466448:新冠病毒感染后的康复运动和心理支持:REGAIN