Effect of a mobile health intervention optimised with artificial intelligence on cardiovascular risk reduction: The My Intelligent Cardiac Assistant (MICArdiac) Study

Not Applicable

• Conditions: Hypertension; Dyslipidaemia; Cardiovascular - Hypertension; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12622000091707
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Participants are eligible if they meet all 3 of the following criteria and have no exclusion criteria.
1.Adults 35 years and over
2.Own a compatible smartphone – iPhone 5 onwards (iOS 10 and higher) or Android (6.0 and higher).
3.Uncontrolled hypertension/high blood pressure (1 of the following):
a)Known hypertension AND at least one recorded measure of SBP equal or above to 140mmHg and/or DBP equal or above to 90 mmHg in the last 12 months; OR
b)At least one recorded measure of SBP equal or above to 160mmHg and/or DBP equal or above to 100 mmHg in the last 12 months; OR
c)At least two recorded measures of SBP equal or above to 140mmHg and/or DBP equal or above to 90 mmHg in the last 12 months.

Exclusion Criteria

•History of cardiovascular disease, including peripheral artery disease, heart failure, coronary heart disease, stroke
•Have a pacemaker, defibrillator or other electrical implant not suited for use with provided wireless monitoring devices.
•Unable to use wearable/wireless monitoring devices provided
•Unable to complete the study procedures or follow-up
•Unable to understand sufficient written English to provide informed consent
•Unable to provide informed consent
•Any condition that in the opinion of the responsible physician or investigator renders the patient unsuitable for the study (e.g. severe disability or significant memory or behavioural disorder)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean Systolic Blood Pressure (SBP) at 6 months between intervention and control groups [average daytime SBP measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)][Baseline and 6 months post-randomisation.]