Effectiveness of a personalised self-management intervention for people living with long covid (Listen trial): pragmatic, multicentre, parallel group, randomised controlled trial.

BMJ medicine Pub Date : 2025-01-31 eCollection Date: 2025-01-01 DOI:10.1136/bmjmed-2024-001068
Monica Busse, Philip Pallmann, Muhammad Riaz, Claire Potter, Fiona J Leggat, Shaun Harris, Andrea Jane Longman, Rachel Lowe, Adrian Edwards, Aloysius Niroshan Siriwardena, Nick Sevdalis, Jackie McRae, Jessica Fish, Bernadette Sewell, Fiona Jones
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Abstract

Objective: To evaluate the effectiveness of Listen, a self-management support intervention, for people living with long covid who were not in hospital.

Design: Pragmatic, multicentre, parallel group, randomised controlled trial.

Setting: Twenty four sites in England and Wales.

Participants: Identified from long covid clinic waiting lists, word of mouth, and adverts/social media self-referred to the trial, 554 adults with long covid were randomised to receive either the Listen trial intervention or NHS usual care.

Interventions: The Listen intervention involved up to six one-to-one personalised sessions with trained healthcare practitioners and an accompanying handbook co-designed by people with lived experience and health professionals. Usual NHS care was variable, ranging from no access, access to mobile applications and resources, and to specialist long covid clinics.

Main outcome measures: The primary outcome was the Oxford participation and activities questionnaire (Ox-PAQ) routine activities scale score at three months assessed in the intention-to-treat population. Secondary outcomes included Ox-PAQ emotional wellbeing and social engagement scale scores, the Short Form-12 (SF-12) health survey, the fatigue impact scale, and the generalised self-efficacy scale at three months. The EuroQol five-dimension five-level (EQ-5D-5L) assessed health utility. Serious adverse events were recorded.

Results: Between 27 May 2022 and 15 September 2023, 554 people with long covid (mean age 50 (standard deviation 12.3) years; 394 (72.4%) women) were randomly assigned. At three months, participants assigned to the intervention group reported small non-significant improvements in the primary outcome of capacity for daily activities as assessed by Ox-PAQ routine activities scale score (adjusted mean difference -2.68 (95% confidence interval (CI) -5.38 to 0.02), P=0.052) compared with usual NHS care. For the secondary outcomes, people receiving the intervention also reported significant improvements in mental health (Ox-PAQ emotional wellbeing -5.29 (95% CI -8.37 to -2.20), P=0.001; SF-12 2.36 (95% CI 0.77 to 3.96), P=0.004), reductions in fatigue (fatigue impact score -7.93 (95% CI -11.97 to -3.88), P<0.001), and increases in self-efficacy (generalised self-efficacy scale 2.63 (95% CI 1.50 to 3.75), P<0.001). No differences were found in social engagement (-2.07 (95% CI -5.36 to 1.22), P=0.218) or SF-12 physical health (0.32 (95% CI -0.93 to 1.57), P=0.612). No intervention related serious adverse events were reported.

Conclusions: The personalised self-management support intervention of the Listen trial resulted in non-significant short term improvements in routine activities when compared with usual care. Improvements in emotional wellbeing, fatigue, quality of life, and self-efficacy for people living with long covid were also reported. Physical health and social engagement were not affected by the trial intervention. The limited understanding of how much change is clinically meaningful in this population along with the unblinded design, the use of self-referral as a recruitment method and variable usual care may have introduced unintended bias and thus limits robust conclusions about this intervention. Further research is required to fully establish the impact of the intervention.

Trial registration number: ISRCTN36407216, ISRCTN registry, registered 27 January 2022.

个性化自我管理干预对长期covid患者的有效性(Listen试验):务实、多中心、平行组、随机对照试验。
目的:评价自我管理支持干预Listen对长期住院的新冠肺炎患者的效果。设计:实用、多中心、平行组、随机对照试验。地点:英格兰和威尔士的24个地点。参与者:从长冠状病毒临床等待名单、口口相传和广告/社交媒体自我引用的试验中确定,554名长冠状病毒的成年人被随机分配,接受Listen试验干预或NHS常规护理。干预措施:聆听干预包括多达六次一对一的个性化会议,由训练有素的医疗保健从业人员和一本由有生活经验的人和卫生专业人员共同设计的手册。通常的NHS护理是可变的,从没有访问,访问移动应用程序和资源,以及专科长期covid诊所。主要结局指标:主要结局指标为牛津参与和活动问卷(Ox-PAQ)常规活动量表评分,在意向治疗人群中评估三个月。次要结果包括Ox-PAQ情绪健康和社会参与量表得分、短表格12 (SF-12)健康调查、疲劳影响量表和三个月时的广义自我效能量表。EuroQol五维五级(EQ-5D-5L)评估健康效用。严重不良事件均有记录。结果:在2022年5月27日至2023年9月15日期间,554例长冠状病毒感染者(平均年龄50岁(标准差12.3);394名(72.4%)女性被随机分配。在3个月时,被分配到干预组的参与者报告了日常活动能力的主要结局,由Ox-PAQ常规活动量表评分评估(调整平均差-2.68(95%置信区间(CI) -5.38至0.02),P=0.052),与常规NHS护理相比,有轻微的无显著改善。对于次要结果,接受干预的人也报告了心理健康的显著改善(Ox-PAQ情绪健康-5.29 (95% CI -8.37至-2.20),P=0.001;SF-12 2.36 (95% CI 0.77至3.96),P=0.004),疲劳减少(疲劳影响评分-7.93 (95% CI -11.97至-3.88),P结论:与常规护理相比,Listen试验的个性化自我管理支持干预导致日常活动的短期改善不显著。据报道,长期感染新冠病毒的人在情绪健康、疲劳、生活质量和自我效能方面都有所改善。身体健康和社会参与没有受到试验干预的影响。对该人群中有多少变化具有临床意义的有限理解以及非盲法设计,使用自我转诊作为招募方法和可变常规护理可能会引入意想不到的偏差,从而限制了对该干预措施的可靠结论。需要进一步的研究来充分确定干预措施的影响。试验注册号:ISRCTN36407216, ISRCTN注册,注册日期为2022年1月27日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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