← Back
NeuroTrials.ai
Neurology Clinical Trial Database

PERKS-International

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

Share Share Copied! Compare

Year of Publication: 2026

Authors: Gall SL, Feigin VL, Chappell K, ..., Krishnamurthi RV

Journal: Stroke

Citation: Stroke. 2026;57:2254-2264. DOI: 10.1161/STROKEAHA.125.054001

Link: https://doi.org/10.1161/STROKEAHA.125.054001

Clinical Question

Does access to the Stroke Riskometer mHealth application improve Life's Simple 7 cardiovascular risk factor scores at 6 months compared with usual care in adults with multiple stroke risk factors?

Bottom Line

Access to the Stroke Riskometer mobile application did not significantly improve overall Life's Simple 7 cardiovascular risk factor scores at 6 months in a primary prevention population compared with usual care, though a nonsignificant trend toward increased physical activity was observed.

Major Points

  • No significant between-group difference in Life's Simple 7 score change at 6 months (mean difference 0.03; P=0.788)
  • Per-protocol analysis also failed to show significant benefit (mean difference 0.20; P=0.106)
  • Nonsignificant trend toward increased physical activity in intervention group (+313.42 MET-min/week; P=0.052)
  • No differences in blood pressure, cholesterol, glucose, BMI, smoking, or diet between groups
  • Study conducted in a general primary prevention population aged 35-75 with ≥2 risk factors
  • Results suggest passive access to an mHealth app alone is insufficient to change risk factor profiles

Design

Study Type: Phase III, prospective, pragmatic, open-label, single-blinded end point, 2-arm randomized controlled trial

Randomization: 1

Blinding: Outcome assessor-blinded (single-blind); block randomization stratified by site

Allocation: 1:1 to intervention vs usual care via pregenerated allocation table using Research Electronic Data Capture

Enrollment Period: August 2021 to January 2024

Follow-up Duration: 12 months (primary outcome at 6 months)

Centers: 5

Countries: Australia, New Zealand

Sample Size: 862

Analyzed: 862

Analysis: Intention-to-treat using ANCOVA and linear mixed models, with prespecified per-protocol and subgroup analyses

Power Calculation: 790 participants (395 per arm) provided 80% power (2-sided α=0.05) assuming 10% drop-out and 10% drop-in rates

Registration: ACTRN12621000211864 (Australian and New Zealand Clinical Trials Registry)

Inclusion Criteria

  • Age ≥35 and ≤75 years
  • ≥2 poor Life's Simple 7 risk factors (self-reported in online screening)
  • No cognitive impairment (Montreal Cognitive Assessment score ≥26)
  • Owns a smartphone
  • Able to speak and understand English

Exclusion Criteria

  • History of stroke
  • History of myocardial infarction
  • Terminal illness
  • Currently participating in another RCT
  • Family/household members of existing participants

Baseline Characteristics

Overall:

  • Mean Age: 58±11 years
  • Female: 63%
  • White: 74%

Arms

FieldIntervention (Stroke Riskometer App)Control
N429433
InterventionAccess to Stroke Riskometer mHealth application with instructions via email, technical support, and reminders at 1 and 3 months post-randomizationSingle email summary of Life's Simple 7 risk factors from baseline measurements with links to online evidence-based stroke prevention information
Duration6 months (primary outcome); 12 months total follow-up6 months (primary outcome); 12 months total follow-up

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Mean between-group difference in Life's Simple 7 score (0=poor to 14=ideal; comprising blood pressure, cholesterol, glucose, BMI, smoking, physical activity, and diet) from baseline to 6 monthsPrimaryUsual care (n=433)App access (n=429)Mean difference in change: 0.03 (ITT); 0.20 (per-protocol)0.788 (ITT); 0.106 (per-protocol)
Change in physical activity (MET-minutes per week)Secondary313.42 MET-min/week increase in intervention group0.052
Change in individual Life's Simple 7 items (blood pressure, cholesterol, glucose, BMI, smoking, diet)SecondaryNo significant differences between groups
Self-reported hospitalizations for cardiovascular disease with medical record adjudicationSafetyNotes: Few harms expected as app is not deemed a medical device per Therapeutic Goods Administration of Australia

Subgroup Analysis

Prespecified subgroup analyses were performed (results not detailed in available text)

Criticisms

  • Open-label design with limited contact between participants and study staff may reflect real-world engagement patterns but limits fidelity assessment
  • App fidelity data limited because App stores data only on individual devices and sharing required additional consent
  • Per-protocol analysis suggests some potential benefit but did not reach significance
  • Passive intervention (app access without active coaching) may explain lack of effect
  • Predominantly White population (74%) may limit generalizability

Funding

Synergies to Prevent Stroke overarching grant

Based on: PERKS-International (Stroke, 2026)

Authors: Gall SL, Feigin VL, Chappell K, ..., Krishnamurthi RV

Citation: Stroke. 2026;57:2254-2264. DOI: 10.1161/STROKEAHA.125.054001

Content summarized and formatted by NeuroTrials.ai.