Effect of a mobile health intervention optimised with artificial intelligence on blood pressure and other cardiovascular risk factors in adults with high blood pressure: rationale and design of My Intelligent Cardiac Assistant (MICArdiac) randomised controlled trial
Clinical Snapshot
PICO Framework
| P — Population | Adults aged 35 years and above with high blood pressure recruited from primary care, hospital clinics, and community settings in Western Sydney, ACT, NSW, and Victoria |
| I — Intervention | MICArdiac programme: 6-month mobile health intervention with BP/activity tracking, personalised messaging, medical review for medication titration, and cardiovascular behavioural change support |
| C — Comparator | Text-message cardiovascular education programme (active control) |
| O — Outcomes | Primary: mean daytime systolic BP by 24-hour ABPM at 6 months. Secondary outcomes not fully detailed in this protocol paper |
Bottom Line
The MICArdiac trial protocol describes a well-designed randomised controlled trial comparing a comprehensive mobile health intervention with personalised messaging to standard text-message education for hypertension management. The study's strength lies in using 24-hour ambulatory BP monitoring as the primary outcome and recruiting across multiple Australian states. However, the open-label design introduces performance bias, and being a protocol paper, actual effectiveness cannot yet be assessed. The intervention's complexity may limit real-world implementation, particularly in populations with limited digital literacy. While the approach is promising and builds on evidence supporting home BP monitoring and text messaging, clinicians should await the full results before considering implementation. The study addresses an important clinical need, as hypertension control remains suboptimal globally, and mobile health interventions offer potential for scalable, personalised care delivery in the Australian healthcare context.
Key Findings
P Value: Not yet available - protocol paper
Effect Size: Not yet available - protocol paper
Primary Outcome: Mean daytime systolic BP by 24-hour ABPM at 6 months
Nnt Or Sensitivity: Not yet available - protocol paper
Confidence Interval: Not yet available - protocol paper
Clinical Application
Requires smartphone access and digital literacy; may be challenging in older or socioeconomically disadvantaged populations Highly relevant to Australian healthcare with recruitment across multiple states; aligns with RACGP hypertension guidelines emphasising self-monitoring and lifestyle modification Australian adults ≥35 years with hypertension in primary care and hospital settings
Abstract
INTRODUCTION: Control of blood pressure (BP) continues to be a challenge globally. Clinical trials have shown home BP monitoring and text-message interventions to lower BP. Integrating these to personalise supportive messaging in response to changing BP and activity through leveraging artificial intelligence (AI) could improve BP control. The aim of this trial is to examine the impact on BP, compared with a text-message only programme, of the My Intelligent Cardiac Assistant (MICArdiac) programme. MICArdiac is a 6-month programme comprising tracking of BP, physical activity and heart rate informing a content stream of AI-driven personalised messages to encourage BP self-management, as-necessary medical review to up-titrate medicines and cardiovascular preventative behavioural change. METHODS AND ANALYSIS: MICArdiac is a prospective randomised open-blinded endpoint randomised controlled trial with 1:1 (intervention:control) allocation and active control. Individuals aged 35 years old or above with high BP are randomised to the MICArdiac programme or to a text-message cardiovascular education programme. Recruitment started in primary care and hospital clinics in Western Sydney and moved to decentralised direct-to-community recruitment in the Australian Capital Territory, New South Wales and Victoria. Randomisation and allocation concealment occur via a secure web-based system. The primary outcome is mean daytime systolic BP measured by 24-hour Ambulatory Blood Pressure Monitoring at 6 months. Primary analysis will follow intention-to-treat principles; data analysts will be blinded. Process evaluation will be conducted. ETHICS AND DISSEMINATION: Ethics approval was obtained from Western Sydney Local Health District Human Ethics Research Committee (2021/ETH11379). TRIAL REGISTRATION NUMBER: ACTRN12622000091707.
References
- 1.Laranjo, L., O'Hagan, E. T., Klimis, H., Marschner, S., & Chow, C. K. (2026). Effect of a mobile health intervention optimised with artificial intelligence on blood pressure and other cardiovascular risk factors in adults with high blood pressure: rationale and design of My Intelligent Cardiac Assistant (MICArdiac) randomised controlled trial. Open Heart, 13(1). https://doi.org/10.1136/openhrt-2025-003819
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