Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000091707
Ethics application status
Approved
Date submitted
30/11/2021
Date registered
24/01/2022
Date last updated
27/03/2023
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a mobile health intervention optimised with artificial intelligence on cardiovascular risk reduction: The My Intelligent Cardiac Assistant (MICArdiac) Study
Scientific title
Effect of a mobile health program optimised with artificial intelligence (My Intelligent Cardiac Assistant—MICArdiac) on Systolic Blood Pressure and other cardiovascular risk factors in adults with high blood pressure: a multi-centre randomised controlled trial
Secondary ID [1] 305135 0
None
Universal Trial Number (UTN)
U1111-1269-0506
Trial acronym
MICArdiac
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 324716 0
Dyslipidaemia 324717 0
Condition category
Condition code
Cardiovascular 320946 320946 0 0
Hypertension
Cardiovascular 322428 322428 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are randomised to the intervention group of the study will receive the MICArdiac mobile health program for 6 months, consisting of the MICArdiac smartphone application (app) connected to two wireless monitoring devices (a blood pressure monitor and a physical activity tracker). The MICArdiac app delivers health messages via in-app notifications, utilising data collected by the wireless monitoring devices to customise messages and using a machine learning algorithm and natural language processing (artificial intelligence) to optimise the content and sequencing of the messages to promote participant engagement with the intervention. The MICArdiac mobile health program aims to improve cardiovascular risk factors in individuals with high blood pressure and high LDL cholesterol. The program was co-designed with researchers, clinicians (GP and Cardiologists) and consumers, and developed in collaboration with the Sydney Informatic Hub (SIH).

MICArdiac app:
The MICArdiac app will deliver the messages and display data collected from the wireless monitoring devices (step counts, exercise duration, blood pressure, heart rate). The MICArdiac app securely collects the participant’s blood pressure measures and physical activity measures from the participant’s GoogleFit app and Apple Healthkit app.

Wireless monitoring devices:
Devices will include a wireless blood pressure monitor and a physical activity tracker (wearable bracelet) with heart rate monitoring ability. Participants will be encouraged to wear the activity tracker at all times, removing the bracelet only when required to charge it. Participants will be instructed to measure their blood pressure using the wireless blood pressure device up to three times a week, with a minimum of one blood pressure recording per week. Participants will be encouraged to measure their blood pressure at different times of the day.

Messages:
The frequency of messages will vary between 4 and 7 messages per week. Messages will be of three main types: 1) educational messages customised using three baseline variables (smoking, vegetarian diet, health literacy) to encourage behaviour change and self-management; 2) weekly adaptive step goals based on data from the physical activity tracker; 3) messages triggered by thresholds in monitored health parameters (blood pressure, heart rate, exercise duration).
1) Educational messages will be drawn from a message bank from 5 topic streams (general cardiovascular health, diet, physical activity, smoking, and medication adherence). The content and sequence of these messages will be optimised by a machine learning algorithm to reduce repetitiveness (message tone and intent, sematic similarity, lexical similarity, message readability) and promote participant engagement with the intervention. The algorithm was developed based on natural language processing analysis of messages and responses from our previous RCTs.
2) Messages containing weekly adaptive step goals will be based on an adaptive algorithm, which first monitors the participant’s step count for one week at baseline then it generates a goal based on this. The algorithm then generates a new goal each week based on the participant’s actual step count and their ability to achieve the previous week’s goal. The aim is to gradually increase participants’ step goals in achievable increments.
3) Threshold-based messages will be of three types: 1) indicating values of health parameters (exercise duration, blood pressure, heart rate) are within the normal/recommended range and encouraging maintenance of health behaviours and management; 2) indicating values are out of the normal/recommended range and encouraging improvement of health behaviours; 3) reminding participants to use wireless monitoring devices, triggered by a lack of data received in the previous week. Extreme values of blood pressure and heart rate will trigger a phone call from a health counsellor.
Intervention usage metrics will be automatically collected via an electronic log recording the time messages are sent and the status of the delivery (i.e. delivered or not delivered). A log of responses received from participants and when participants contact the study team, including the reason for contact and the method used will also be kept. At the 6-month follow up, Intervention participants will be asked to complete a structured questionnaire and explore participants’ acceptability of the program (what percentage of messages did they read, which messages they remember, liked or disliked, what they did with the message, i.e. kept or deleted, whether messages were shown to family/friends and/or forwarded, whether the messages prompted some sort of action or behaviour change, whether messages were well understood or confusing). Use of the devices will be monitored using a rule-based threshold approach. If no data is received in the week period, a message reminding the participants to use the device will be sent. Finally, the log history of the devices digital user dashboard will be used to measure overall engagement in the intervention group.
Intervention code [1] 321543 0
Prevention
Intervention code [2] 321544 0
Treatment: Other
Intervention code [3] 321545 0
Behaviour
Comparator / control treatment
The control arm will receive a standard text message program for 6 months. This message program will be similar to our previous TEXTME and TextMe2 trials, which demonstrated efficacy in improving modifiable cardiovascular disease (CVD) risk factors. Messages will be randomly selected from 5 topic streams (general cardiovascular health, diet, physical activity, smoking, and medication adherence) and will be semi-customised using two baseline variables (smoking status and vegetarian diet). Unlike the intervention group, the customisation will be based on a fixed algorithm. Four messages will be sent per week and delivered as a text-message (i.e. Short Message Service, SMS). Four messages will be sent per week and will provide education, support and motivation to modify risk factors. Unlike the intervention group, the messages will be based on a fixed algorithm. Messages will be sent at random times between 9 am and 5 pm during weekdays. Control usage metrics will be automatically collected via an electronic log recording the time messages are sent and the status of the delivery (i.e. delivered or not delivered). Additionally, a log will be kept of responses received from participants and when participants contact the study team, including the reason for contact and the method used.
Control group
Active

Outcomes
Primary outcome [1] 328727 0
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)]
Timepoint [1] 328727 0
Baseline and 6 months post-randomisation.
Secondary outcome [1] 400141 0
Total Cholesterol, LDL Cholesterol, HDL Cholesterol,, Triglycerides (mmol/L) measured by blood sample.
Timepoint [1] 400141 0
Baseline and 6 months post-randomisation.
Secondary outcome [2] 403664 0
Body mass index measured by digital scales and height according to national standards.
Timepoint [2] 403664 0
Baseline and 6 months post-randomisation.
Secondary outcome [3] 403665 0
Servings of vegetables and fruit consumed each day (self-reported) over the last 7 days, using a study-specific 3-item questionnaire.
Timepoint [3] 403665 0
Baseline and 6 months post-randomisation.
Secondary outcome [4] 403666 0
Validated single-item physical activity question (Bauman AE, Richards JA. Understanding of the Single-Item Physical Activity Question for Population Surveillance. Journal of Physical Activity and Health. 2022 Sep 19;19(10):681-6.)
Timepoint [4] 403666 0
Baseline and 6 months post-randomisation.
Secondary outcome [5] 403667 0
Self-reported smoking status and quit attempts for those who were identified as current smokers at baseline using a study specific questionnaire.
Timepoint [5] 403667 0
Baseline and 6 months post-randomisation.
Secondary outcome [6] 403668 0
Quality of life as assessed by the EQ-5D-5L Health Survey
Timepoint [6] 403668 0
Baseline and 6 months post-randomisation.
Secondary outcome [7] 403669 0
Hypertension knowledge - measured by study specific questionnaire (proportion of correct answers)
Timepoint [7] 403669 0
Baseline and 6 months post-randomisation.
Secondary outcome [8] 403670 0
Health care utilisation: primary care visits, specialist visits, cardiovascular emergency department presentations and unplanned cardiovascular hospitalisations (self-reported in past 6 months at baseline and at 6 months post-randomisation)
Timepoint [8] 403670 0
Baseline and 6 months post-randomisation.
Secondary outcome [9] 420108 0
24h average Systolic Blood Pressure (SBP) measured by ABPM
Timepoint [9] 420108 0
Baseline and 6 months post-randomisation
Secondary outcome [10] 420109 0
Alcohol intake measured using a study specific questionnaire
Timepoint [10] 420109 0
Baseline and 6 months post-randomisation
Secondary outcome [11] 420110 0
24h average Diastolic Blood Pressure (DBP) measured by ABPM
Timepoint [11] 420110 0
Baseline and 6 months post-randomisation
Secondary outcome [12] 420111 0
First SBP measured by ABPM (equating to office BP)
Timepoint [12] 420111 0
Baseline and 6 months post-randomisation
Secondary outcome [13] 420112 0
First DBP measured by ABPM (equating to office BP)
Timepoint [13] 420112 0
Baseline and 6 months post-randomisation
Secondary outcome [14] 420113 0
Daytime average DBP measured by ABPM
Timepoint [14] 420113 0
Baseline and 6 months post-randomisation
Secondary outcome [15] 420114 0
Night time average SBP measured by ABPM
Timepoint [15] 420114 0
Baseline and 6 months post-randomisation.
Secondary outcome [16] 420115 0
Night time average DBP measured by ABPM
Timepoint [16] 420115 0
Baseline and 6 months post-randomisation

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Baseline data (including objective measures and surveys) will be collected prior to randomisation. A researcher will manage participant randomization withinRedCap as they are recruited. The software will automatically allocate participants to the intervention or control group, according to the randomisation sequence generated in R (using the randomiseR package) and uploaded to RedCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated in R (using the randomiseR package) and uploaded to RedCap.
Eligible participants will be randomised into either the intervention arm (MICArdiac digital health program) or control arm (standard text message program) in a 1:1 intervention:control allocation ratio, stratified by two variables: whether or not patients are taking blood pressure lowering medication, and by recruitment site at primary care/community or secondary care facility.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 500 participants in a 1:1 ratio (250:250) would give us 96% power to detect a between-group difference in ambulatory daytime average SBP of 4 mmHg (SD 11 mmHg)(19) using a 5% level of significance and accounting for a drop-out rate of ~20%.

Our primary analysis will follow the principles of intention-to-treat to compare participants in the intervention group to that in the control group. We will also report results from analysis per-protocol. T-tests using analysis of covariance will be used to compare mean changes in the primary outcome. For secondary analyses, regression models will be used to compare the treatment groups using the appropriate model for the type of outcome variables, adjusting for baseline variables if relevant. Log binomial models will be used for dichotomous variables and regression models for continuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20349 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 35111 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 309526 0
Charities/Societies/Foundations
Name [1] 309526 0
Tides Foundation
Country [1] 309526 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
83-117 Missenden Rd Camperdown NSW 2050 Australia Postal Address: PO Box M201 Missenden Rd NSW 2050 Australia 2145
Country
Australia
Secondary sponsor category [1] 310513 0
None
Name [1] 310513 0
Address [1] 310513 0
Country [1] 310513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309307 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309307 0
Research Office Level 2 REN Building Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 309307 0
Australia
Date submitted for ethics approval [1] 309307 0
30/08/2021
Approval date [1] 309307 0
08/11/2021
Ethics approval number [1] 309307 0
2021/PID02564/ETH11379

Summary
Brief summary
MICArdiac study is a 6-month multi-centre randomised controlled trial to determine whether an adaptive mobile health program optimised with artificial intelligence can improve cardiovascular risk factors in a primary prevention cohort, compared to a standard text-message program. The study population will be participants who have high blood pressure, with no prior history of cardiovascular disease. Participants must be over 35 years of age and own a compatible smartphone. Potential participants will be identified through cardiometabolic clinics, primary care and the community.
Patients will be randomised to MICArdiac intervention or standard-text care in a 1:1 allocation ratio. The intervention group will receive MICArdiac mobile health program comprised of the MICArdiac smartphone app, messages delivered via in-app notifications, and two wireless monitoring devices (blood pressure monitor and physical activity tracker). The primary outcome is the mean change in systolic blood pressure between intervention and control at 6 months. The MICArdiac mobile health program was co-designed with researchers, clinicians (GP and Cardiologists) and consumers, and developed in collaboration with the Sydney Informatic Hub (SIH), being downloadable via the Apple and Google app stores. This study was funded through the Tides foundation and Australian Stroke and Heart Research Accelerator (ASHRA) and aims to recruit a total of 500 patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113710 0
Prof Clara Chow
Address 113710 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre. Level 6, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 113710 0
Australia
Phone 113710 0
+61 2 86273580
Fax 113710 0
Email 113710 0
[email protected]
Contact person for public queries
Name 113711 0
Dr Liliana Laranjo
Address 113711 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre. Level 6, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 113711 0
Australia
Phone 113711 0
+61 413461852
Fax 113711 0
Email 113711 0
[email protected]
Contact person for scientific queries
Name 113712 0
Dr Liliana Laranjo
Address 113712 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre. Level 6, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 113712 0
Australia
Phone 113712 0
+61 413461852
Fax 113712 0
Email 113712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.