OA33 A randomised controlled trial to assess the feasibility and acceptability of remote psychosocial and exercise interventions for people with lupus: the ADAPT feasibility trial

Abstract

Background/Aims Limited support is available to help people adapt to living with lupus despite the highly reduced quality of life, and almost 50% of lupus patients having experienced suicidal thoughts. Reducing the high burden of symptoms through psychosocial and exercise interventions could lead to significant savings in healthcare costs, in addition to being life-improving for patients. The aim of this study was to assess the acceptability, feasibility and indications of effectiveness of psychosocial and exercise interventions to inform a large-scale definitive trial. Methods This study was a pre-registered randomised controlled trial (ISRCTN:72406488). Participants were SLE patients (N = 124). Participants were randomised to either a control arm or one of three interventions delivered remotely over 8-12 weeks: 1) The Wren project (providing listening support), 2) Pilates classes, and 3) supportive and educational texts/videos. Feasibility, acceptability, and effectiveness measures were collected through online surveys (at Baseline, 12 and 26 weeks) and qualitative interviews. Validated instruments included: depression (PHQ-8), fatigue (FACIT-F), resilience (CD-RISC) and our co-designed “ADAPT” measure. Progression criteria to a definitive trial were pre-defined. Hedge’s g and linear regression were used to estimate within and between-arm differences in effectiveness measures. Qualitative data were analysed using thematic analysis. Results Participants were mostly female (97%) and white (82%). We found high levels of feasibility for all interventions. Pre-defined acceptability criteria of > 75% rating the intervention as acceptable/highly acceptable were met for all interventions. The Pilates intervention had the highest proportion of withdrawals/non-attendance (primarily due to ill health). Satisfaction with Pilates was reported for both physical and mental health: “It was the first time I had the opportunity to engage with others with lupus which made me feel less alone. My body and mind feel stronger, and I have a higher sense of self-worth for taking part” (Ppt 001, 40’s), and The Wren participants particularly valued having a “safe space” to talk. Although the text/video programme was acceptable, feasible, and low cost to deliver, 41% of participants stated that they would rather have received a different intervention. Several areas of improvement for the text/video programme were suggested. This included greater tailoring, particularly to stage of disease journey as what was considered acceptable and helpful to a newly diagnosed participant was often viewed as patronising to more experienced patients. Estimates of effectiveness favoured the interventions compared to control, and there was evidence of improved resilience and depression (all interventions), and fatigue (Pilates). Conclusion All interventions were assessed as feasible and acceptable to progress to a large-scale definitive trial, although the text/video intervention requires improvements. A complex multi-stage intervention is required as individual interventions are unlikely to have a positive effect on all of the diverse areas requiring support for people with lupus and other rheumatological diseases. Disclosure M. Sloan: None. D. D’Cruz: Corporate appointments; Leadership position on the APS charity board. Consultancies; Consultancy/speaker fees from GSK, Eli Lilly, Vifor and UCB. T.A. Pollak: None. W. Diment: None. M. Bosley: None. E. Lever: None. F. Mann: None. B. Sloan: None. S. Morris: None. J. Brimicombe: None. F. Naughton: None.