Effectiveness of a personalised self-management intervention for people living with Long Covid: the LISTEN randomised controlled trial

Busse-Morris, Monica ORCID: https://orcid.org/0000-0002-5331-5909, Pallmann, Philip ORCID: https://orcid.org/0000-0001-8274-9696, Riaz, Muhammad ORCID: https://orcid.org/0000-0002-5512-1745, Potter, Claire, Leggat, Fiona, Harris, Shaun, Longman, Andrea, Lowe, Rachel, Edwards, Adrian ORCID: https://orcid.org/0000-0002-6228-4446, Siriwardenaf, Aloysius Niroshan, Sevdalis, Nick, McRae, Jackie, Fish, Jessica, Sewell, Bernadette and Sewell, Bernadette 2024. Effectiveness of a personalised self-management intervention for people living with Long Covid: the LISTEN randomised controlled trial. BMJ Medicine

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Abstract

Objective. To evaluate the effectiveness of LISTEN, a self-management support intervention, for non-hospitalised people living with Long Covid. Design. Pragmatic, multi-centre, parallel group, superiority randomised controlled trial. Setting. Twenty-four sites in England and Wales. Participants. Five hundred and fifty-four adults with Long Covid, identified from long covid clinic waiting lists, word of mouth and adverts/social media self-referred to the trial and 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 co-designed handbook. Usual NHS care was variable ranging from no access, to access to mobile applications and resources, to specialist Long Covid clinics. Main outcome measures. The primary outcome was the Oxford Participation and Activities Questionnaire (Ox-PAQ) routine activities scale score (RASS) at three months. Secondary outcomes included Ox-PAQ emotional wellbeing (EWSS) and social engagement (SESS) scale scores, the Short Form-12 (SF-12) Health Survey, the Fatigue Impact Scale (FIS), and the Generalised Self-Efficacy Scale (GSES). Serious adverse events were recorded. The EuroQol five-dimension five-level (EQ-5D-5L) assessed health utility. Results. Between June 2022 and November 2023, 554 people with Long Covid (mean (SD) age 50 (12.3) years; 394 (72.4%) female) were randomised. At three months, LISTEN intervention arm participants reported small non-significant improvements in capacity for daily activities as assessed by Ox-PAQ RASS (adjusted mean difference (95% confidence interval) -2.68 (-5.38, 0.02), p=0.052) compared to usual NHS care. Those receiving the intervention also reported significant improvements in mental health (Ox-PAQ EWSS -5.29 (-8.37, -2.20), p=0.001; SF-12 2.36 (0.77, 3.96), p=0.004), reductions in fatigue impact (FIS -7.93 (-11.97, -3.88), p<0.001), and increases in self-efficacy (GSES 2.63 (1.50, 3.75), p<0.001). No differences were found in social engagement (SESS -2.07 (-5.36, 1.22), p=0.218) or SF-12 physical health 0.32 (-0.93, 1.57), p=0.612). There were no intervention-related serious adverse events. Conclusions. The LISTEN personalised self-management support intervention resulted in non-significant short-term improvements in routine activities when compared to 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 impacted on 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.

Item Type:	Article
Status:	In Press
Schools:	Centre for Trials Research (CNTRR) Medicine
Publisher:	BMJ Publishing Group
Funders:	National Institute of Health Research
Date of First Compliant Deposit:	21 November 2024
Date of Acceptance:	20 November 2024
Last Modified:	21 Nov 2024 10:30
URI:	https://orca.cardiff.ac.uk/id/eprint/174193

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