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

• Published in: PLoS medicine 2022-04, Vol.19 (4)
• Main Authors: Ashleigh Guillaumier, Neil J. Spratt, Michael Pollack, Amanda Baker, Parker Magin, Alyna Turner, Christopher Oldmeadow, Clare Collins, Robin Callister, Chris Levi, Andrew Searles, Simon Deeming, Brigid Clancy, Billie Bonevski
• Format: Article
• Language: English
• ISSN: 1549-1277; 1549-1676

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 us