Randomized Controlled Trial Testing the Efficacy of an mHealth Application to Reduce Risk Factors for the Primary Prevention of Stroke.

BACKGROUND

We evaluated the efficacy of the Stroke Riskometer mobile phone application to change the Life's Simple 7 risk factor score in a primary prevention population at 6 months postrandomization.

METHODS

This phase III, prospective, outcome assessor-blinded, 2-arm randomized controlled trial in Australia and New Zealand recruited participants from August 2021 to January 2024. Inclusion criteria: age ≥35 and ≤75 years; ≥2 risk factors; smartphone ownership; and no cardiovascular disease history. The intervention group was given access to the application; the usual care group received one email with generic risk factor information. The primary outcome was the mean between-group difference in Life's Simple 7 (score 0 [poor] to 14 [ideal], comprising blood pressure, cholesterol, glucose, body mass index, smoking, and physical activity and diet) from baseline to 6 months postrandomization. Secondary outcomes were between-group changes in individual Life's Simple 7 items. Analyses were performed using intention-to-treat principles with ANCOVA and linear mixed models to examine differences between groups, with prespecified per-protocol and subgroup analyses.

RESULTS

We randomized 862 participants (mean±SD age, 58±11 years; 63% women; 74% White). At 6 months postrandomization in intention-to-treat analyses, the mean difference between usual care (n=433) and intervention (n=429) groups in the change in Life's Simple 7 score from baseline was 0.03 ([95% CI, -0.19 to 0.25]; P=0.788). Per-protocol analyses (n=320 usual care; n=276 intervention) were similar (mean difference in change, 0.20 [95% CI, -0.04 to 0.43]; P=0.106). Compared with usual care in intention-to-treat analyses, the intervention group had a nonsignificant increase in metabolic equivalent of task (metabolic equivalent of task) minutes per week of physical activity (313.42 [95% CI, -2.80 to 629.65]; P=0.052), with no differences in other Life's Simple 7 items.

CONCLUSIONS

Among a general population aged 35 years to 75 years with ≥2 stroke risk factors, there was no evidence that having access to the application changed overall Life's Simple 7 scores at 6-month follow-up. Participants in the intervention group did have a nonsignificant increase in physical activity, compared with the usual care group, after 6 months, but not in other individual risk factors.

REGISTRATION: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12621000211864.