Online randomised controlled trial to evaluate the clinical and cost-effectiveness of a web-based peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives’ Education And Coping Toolkit (REACT)

Lobban, Fiona and Jones, Steven and Robinson, Heather and Sellwood, Bill (2019) Online randomised controlled trial to evaluate the clinical and cost-effectiveness of a web-based peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives’ Education And Coping Toolkit (REACT). Health Technology Assessment. ISSN 1366-5278 (In Press)

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Abstract

Background Relatives caring for people with severe mental health problems find information and emotional support hard to access. Online support for self-management offers a potential solution. Objective To determine the clinical and cost-effectiveness of an online supported self-management tool for relatives, the Relatives’ Education And Coping Toolkit (REACT). Design A primarily online, single-blind, randomised controlled trial, comparing REACT plus a resource directory (RD) and treatment as usual (TAU), against the RD and TAU only, by measuring user distress and other wellbeing measures at start, 12 and 24 weeks. Participants 800 relatives across UK, aged 16 or over, with high levels of distress, access to Internet, and actively seeking help. Intervention REACT comprised 12 psychoeducation modules, peer support through a group forum, confidential messaging, and a comprehensive RD of national support. Trained relatives moderated the forum and responded to messages. Main outcome measure Participants’ distress, measured by the General Health Questionnaire (GHQ-28). Results Recruitment was via study website. Various online and offline strategies including social media directed potential participants to the site. Participants were randomised into two groups: REACT plus RD (n=399) or RD only (n=401). Retention at 24 weeks was 75% (REACT n=292; RD-only n=307). Mean GHQ-28 scores fell substantially across both groups over 24 weeks, from mean 40.2, standard deviation (SD) 14.3 to mean 30.5, SD 15.6, with no significant difference between groups (-1.39, 95% CI -3.60–0.83, p=0.22). At 12 weeks GHQ-28 scores were lower in the REACT arm than in RD-only (-2.08, 95% CI -4.14– -0.03, p=0.027), but of likely limited clinical significance. Accounting for missing data, which was associated with higher distress in the REACT arm (0.33, 95% CI -0.27–0.93, p=0.279), in a longitudinal model, there was no significant difference between groups over 24 weeks (-0.56, 95% CI–2.34–1.22, p=0.51). iv REACT cost £142.95 per participant to design and deliver (£62.27 delivery only) against £0.84 for RD-only. Health economic analysis of NHS, health and personal social services outcomes found REACT to have higher costs of £286.77, slightly better GHQ scores (incremental GHQ adjusted for baseline, age and gender: -1.152, 95% CI -3.370–1.065), and slightly lower QALYs than RD-only; none of these differences was statistically significant. Median time spent online was 50.8 minutes for REACT (IQR 12.4–172.1) with no significant association against outcome. Participants reported finding REACT a safe, confidential environment (96%), and feeling supported by the forum (89%) and REACT supporters (86%). No serious adverse events reported. Limitations Predominantly white British female sample; 25% lost to follow-up; dropout in the REACT group was not random. Conclusions An online self-management support toolkit with moderated group forum is acceptable to relatives and, compared to face-to-face programmes, offers inexpensive, safe delivery of NICE-recommended support to engage relatives as peers in care delivery. However, currently, REACT plus RD is no more effective in reducing relatives’ distress than RD-only. Future work Further research in improving the effectiveness of online carer support interventions. Study registration ISRCTN72019945 Funding source NIHR Health Technology Assessment programme (14/49/34).