Evaluation of an online intervention for improving stroke survivors’ health-related quality of life: A randomised controlled trial

Abstract

Background The aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention—Prevent 2nd Stroke (P2S)—at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up. Methods and findings A prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable ‘stroke event (stroke/transient ischaemic attack/other)’ as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79–9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05–4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06–2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly ‘well’ stroke survivors with limited to no disability. Conclusions The P2S online healthy lifestyle program improved stroke survivors’ self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool to engage and support some stroke survivors. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12617001205325. Ashleigh Guillaumier and colleagues evaluate the effectiveness of an online health behaviour change intervention aimed at improving health-related quality of life amongst stroke survivors. Author summary Why was this study done? Stroke can lead to serious consequences for those who survive in terms of physical and cognitive disability, psychological problems, and lower social participation, affecting quality of life. Improving lifestyle and health risk behaviours (including reducing tobacco and alcohol use, increasing physical activity, improving diet quality, and reducing depression and anxiety) has the potential to significantly improve recovery, enhance quality of life and independent living, and lower risk of recurrent stroke. The prevalence of health risk factors amongst stroke survivors is high. There is a striking lack of information for stroke survivors and their families about effective lifestyle strategies to help them improve recovery and reduce the risk of recurrent stroke. What did the researchers do and find? We developed an online program (Prevent 2nd Stroke) providing easily accessible, interactive, tailored healthy lifestyle and behaviour change information that encouraged users to set goals and monitor progress across 6 core modules: (1) smoking, (2) alcohol, (3) activity, (4) nutrition, (5) feelings and mood, and (6) blood pressure. Adult stroke survivors (n = 399) participated in a randomised controlled trial. Participants completed a telephone survey and then were randomised to the online Prevent 2nd Stroke program arm (participants received access to the online program and were encouraged to use it over a 12-week period) or a control arm (participants were sent a list of generic health information websites). All participants completed a follow-up survey 6 months after their first survey. Participants who had access to the online program rated their overall health and well-being 5 points higher on average than participants who received a generic list of health behaviour information websites. What do these findings mean? Online platforms are a viable and impactful model to address the health information needs and behaviour change challenges of stroke survivors. Future studies should test program adaptations particularly for those with greater stroke-related disability.