Mobile Technology for Primary Stroke Prevention: A Proof-of-Concept Pilot Randomized Controlled Trial

Background and Purpose Feasibility of utilizing the Stroke Riskometer App (App) to improve stroke awareness and modify stroke risk behaviors was assessed to inform a full randomized controlled trial. Methods A parallel, open-label, 2-arm prospective, proof-of-concept pilot randomized controlled trial. Participants were randomized to usual care/control or App intervention group and assessed at baseline, 3, and 6 months. The App measures stroke risk and provides information on management of risk factors. Participants were aged >19 years with at least 2 modifiable stroke risk factors identified, no prior stroke, and owned a smartphone. Results Fifty participants (24 control, 26 App) were recruited from 148 eligible participants. Retention in the trial was 87%. Mean cardiovascular health (Life's Simple 7) improved by 0.36 (95% CI, -2.10 to 1.38) in the App group compared with 0.01 (95% CI, -1.34 to 1.32) in controls (P=0.6733). Conclusions These findings support a full randomized controlled trial to test the effectiveness of the Stroke Riskometer for primary stroke prevention. Clinical Trial Registration URL: www.anzctr.org.au. Unique Identifier: ACTRN12616000376448.