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改善身心健康的新冠后最佳健康计划:一项可行性随机对照试验

Long COVID Optimal Health Programme to Enhance Mental and Physical Health: A Feasibility Randomised Controlled Trial.

作者信息

Al-Jabr Hiyam, Castle David J, Thompson David R, Windle Karen, Belcher John, Valenzuela Mónica M De Icaza, Helliwell Toby, Ski Chantal F

机构信息

School of Medicine, Keele University, Staffordshire, UK.

Department of Research and Innovation, Midlands Partnership University NHS Foundation Trust, Stafford, UK.

出版信息

Health Expect. 2025 Aug;28(4):e70399. doi: 10.1111/hex.70399.

DOI:10.1111/hex.70399
PMID:40836768
Abstract

INTRODUCTION

Long COVID (LC) is characterised by fatigue, muscle weakness and impaired concentration among other symptoms. No standardised diagnostic or treatment pathway is yet available, though a holistic, person-centred approach to symptom management is recommended. The LC Optimal Health Programme (LC-OHP) is a psychoeducational programme designed to support the mental and physical health of people with LC. This study aimed to examine the feasibility of delivering the LC-OHP to people with LC.

METHODS

This was a feasibility randomised controlled trial of the LC-OHP conducted across the UK. Adults diagnosed with LC were recruited and randomised to control (usual care) or to intervention (LC-OHP) groups; follow-up questionnaires were completed at three- and 6-months (December 2021 to May 2023).

RESULTS

Sixty participants were recruited with a completion rate of 83% (n = 50). Most participants in the LC-OHP group completed programme sessions (n = 19, 68%), rated the programme positively (n = 23, 87%); and felt that it had potential to improve health outcomes (n = 42, 70%). Initial findings demonstrate improvements across all variables at 3- and 6-months, and more so for the LC-OHP group than the control group in the short-term.

CONCLUSION

Findings support the feasibility of delivering the LC-OHP to people with LC. Further, initial data demonstrate potential for the programme to improve most outcomes at three and 6 months. Data from this feasibility trial will be used as an evidence base to support a fully powered RCT of the LC-OHP on patients with LC.

PATIENT OR PUBLIC CONTRIBUTION

The LC-OHP programme was adapted from the original OHP. Taking into account the various symptoms that people with LC experience, including fatigue and brain fog, public members were not directly involved in the design of the study; however, several approaches were considered to obtain ongoing support from public members while conducting the study, to suit people with LC. This included consulting with practitioners who care for people with LC and implementing their feedback, implementing prior feedback from patients with other chronic health conditions who used the OHP in previous studies, and collecting and implementing feedback from participants receiving this programme in this study. Additionally, two public members with lived LC experience were members of the data management committee that overviewed the study progress and provided continuous support. Public members and practitioners provided advice and guidance on different aspects related to the LC-OHP programme and to the process of delivering it to study participants. This included making the programme concise, visual, colourful, and more user-friendly, and adjusting and adapting the mode and timing of delivering the programme sessions (i.e., reduce the session duration, use convenient delivery methods) as preferred by study participants.

TRIAL REGISTRATION

ISRCTN trial register: registration number 38746119, https://doi.org/10.1186/ISRCTN38746119.

摘要

引言

长新冠(LC)的特征包括疲劳、肌肉无力和注意力不集中等症状。目前尚无标准化的诊断或治疗途径,不过建议采用整体的、以患者为中心的症状管理方法。长新冠优化健康计划(LC-OHP)是一项心理教育计划,旨在支持长新冠患者的身心健康。本研究旨在探讨向长新冠患者提供LC-OHP的可行性。

方法

这是一项在英国进行的关于LC-OHP的可行性随机对照试验。招募被诊断为长新冠的成年人,并将其随机分为对照组(常规护理)或干预组(LC-OHP);在3个月和6个月时(2021年12月至2023年5月)完成随访问卷。

结果

招募了60名参与者,完成率为83%(n = 50)。LC-OHP组的大多数参与者完成了课程(n = 19,68%),对该计划给予了积极评价(n = 23,87%);并认为该计划有改善健康结果的潜力(n = 42,70%)。初步研究结果表明,在3个月和6个月时,所有变量均有改善,且短期内LC-OHP组的改善程度大于对照组。

结论

研究结果支持向长新冠患者提供LC-OHP的可行性。此外,初步数据表明该计划在3个月和6个月时改善大多数结果的潜力。该可行性试验的数据将用作证据基础,以支持对长新冠患者进行的LC-OHP的充分有力的随机对照试验。

患者或公众贡献

LC-OHP计划改编自原始的OHP。考虑到长新冠患者经历的各种症状,包括疲劳和脑雾,公众成员未直接参与研究设计;然而,在开展研究时考虑了几种方法以获得公众成员的持续支持,以适应长新冠患者。这包括咨询照顾长新冠患者的从业者并实施他们的反馈,实施先前使用OHP的其他慢性健康状况患者的反馈,以及收集和实施本研究中接受该计划的参与者的反馈。此外,两名有长新冠亲身经历的公众成员是数据管理委员会的成员,该委员会负责监督研究进展并提供持续支持。公众成员和从业者就与LC-OHP计划及其向研究参与者提供的过程相关的不同方面提供了建议和指导。这包括使计划简洁、直观、丰富多彩且更便于用户使用,并根据研究参与者的偏好调整和适应课程提供的方式和时间(即缩短课程时长,使用便捷的提供方式)。

试验注册

ISRCTN试验注册库:注册号38746119,https://doi.org/10.1186/ISRCTN38746119 。

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