Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000869370
Ethics application status
Approved
Date submitted
5/06/2017
Date registered
15/06/2017
Date last updated
14/07/2022
Date data sharing statement initially provided
14/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
"Apps for health following a heart event: MyHeartMate”
Scientific title
Effect of a smartphone app My Heart Mate on cardiovascular disease (CVD) risk factor behaviours and outcomes in coronary heart disease patients: a pilot study
Secondary ID [1] 291976 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 303332 0
Condition category
Condition code
Cardiovascular 302766 302766 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- All participants will receive ongoing standard care for their cardiovascular health, including medications and secondary prevention advice from their doctors and referral to cardiac rehabilitation (CR) program.
A free copy of the patient information booklet: “Managing My Heart Health” from the Heart Foundation (NSW Division) will be supplied.

- The MyHeartMate app applies several successful game techniques, including point systems, built-in challenges and tracking of achievements
- Participants select short and long-term missions to undertake, which earn them points that they use to care for their virtual heart.
- ‘Missions’ include short- and long-term (up to 7 days) healthy lifestyle activities such as-
* healthy eating choices
* physical activity
* not smoking
* talking to their doctor and family about their feelings (psychological health)
* taking their medications
* engaging in behaviours to improve blood glucose and cholesterol levels.
Points earned are used to purchase heart care items such as food, exercise, relaxation and medications, which when spent, improve the visible health of their virtual heart.
- They can share their achievements (points) via a community leaderboard and invite their friends (other known players) to share their leaderboard.
- Fun games such as block movers and word guessing are included to enhance engagement with the game.
- Patients track their real-world achievement by entering their current levels of exercise (daily) and blood pressure and weight (weekly).
The My Heart Mate interventional arm will receive:
- an instructional video about the purpose and way to use the MyHeartMate app (https://www.youtube.com/watch?v=mpf-Vs06aRU),
- the MyHeartMate app as a free download on their smart phone or tablet,
- an invitation to participate in the MyHeartMate Facebook community (closed group),
- a follow-up email at approximately two weeks from the research team to check they have successfully downloaded and are using the app,
- weekly notification from the app if they do not use the app for a week (three times only), - automated emails generated via the app when they have met particular goals (“missions”) and/or challenges.

The participants are expected (but not required) to spend a short amount of time (up to 30 minutes) per day engaging with the app.

Participants will be followed up at 6 months when all primary and secondary outcome measurements will be repeated as per baseline.

Participants will be allocated to the intervention or control group following registration with the study coordinator based at the University.
The study coordinator will use an online web-based random assignment tool (https://www.randomizer.org/) to generate the randomisation schedule.
Allocation will be recorded by the study coordinator and the research assistant informed and actioned.
Baseline data will be collected at the hospital and a Fitbit will be applied on discharge date by the Research Assistant (Registered Nurse with 20 years experience).
Fitbits will be required to be worn for 4 continuous days (2 weekdays and 2 week-end days) at baseline and 6 months.
Patients will be provided with a Fitbit Flex to wear on their wrist and instructions on wearing for the measurement period and provided with a stamped self-addressed envelope for returning.
Fitbit Flex does not have a user interface/screen so participants cannot check their step count to meet any self-imposed or subconscious goal – this aims to reduce behaviour change that may occur simply as a result of monitoring.

Participants in the interventional arm will be contacted 1 week after discharge from hospital to confirm usage of the app and to determine if there are any difficulties experienced with usage.
Participants will be contacted at 3 months and will receive a text message as a reminder of the study and the follow-up due at 6 months
Intervention code [1] 298105 0
Rehabilitation
Intervention code [2] 298280 0
Lifestyle
Comparator / control treatment
The control arm will receive ongoing standard care for their cardiovascular health, including medications and secondary prevention advice from their doctors and referral to cardiac rehabilitation (CR) program.
A free copy of the patient information booklet: “Managing My Heart Health” from the Heart Foundation (NSW Division) will be supplied.

Participants will be contacted at 3 months and will receive a text message as a reminder of the study and the follow-up due at 6 months
Control group
Active

Outcomes
Primary outcome [1] 302154 0
The primary outcome of the study is change in physical activity as measured in MET minutes/week (activity based calories burned/week measured by blinded Fitbit Flex) for 4 continuous days (2 weekdays and 2 week-end days) at baseline and 6 months. .
Timepoint [1] 302154 0
6 months at follow up
Secondary outcome [1] 334976 0
Blood Pressure (Non-invasive sphygmomanometer)
Systolic blood pressure will be assessed while resting a minimum of 2 readings at intervals of at least 1 minute and the average used. If there is > 5mmHg difference between the first and second readings an additional reading will be taken and the average of these multiple readings used.
Timepoint [1] 334976 0
6 months at follow up
Secondary outcome [2] 335707 0
Total Cholesterol in serum plasma
Timepoint [2] 335707 0
6 months at follow up
Secondary outcome [3] 335708 0
Steps/week counted by Fitbit measured after wearing for 4 continuous days (2 weekdays and 2 week-end days)
Timepoint [3] 335708 0
6 months at follow up
Secondary outcome [4] 335709 0
Waist Circumference - Tape Measure measuring halfway between the lowest rib and iliac crest
Timepoint [4] 335709 0
6 months at follow up
Secondary outcome [5] 335710 0
Body Mass Index - Calculated by dividing weight (in kilograms) by height (in metres squared)
Timepoint [5] 335710 0
6 months at follow up
Secondary outcome [6] 335711 0
Attendance at Cardiac Rehabilitation - Patient interview
Timepoint [6] 335711 0
6 months at follow up
Secondary outcome [7] 335712 0
Composite secondary outcome - Anxiety and Depression symptoms - measured using the Hospital Anxiety and Depression Scale [HADS]
Timepoint [7] 335712 0
6 months at follow up
Secondary outcome [8] 335887 0
Triglycerides in serum plasma
Timepoint [8] 335887 0
6 months
Secondary outcome [9] 335888 0
LDL in serum plasma
Timepoint [9] 335888 0
6 months

Eligibility
Key inclusion criteria
Participants will be recruited from cardiac wards in Northern Sydney Local Health District (Royal North Shore, Ryde, Hornsby Ku-ring-gai and Manly Hospitals), Sydney Local Health District (Royal Prince Alfred Hospital), and Western Sydney Local Health District (Westmead Hospital), and North Shore Private Hospital. They will be eligible for the study if the current hospital admission is due to a diagnosis of coronary artery disease (documented myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or 50% or greater stenosis in at least one major epicardial vessel on coronary angiography), they own a smart phone or tablet, use at least one app on their smart phone or tablet, and understand sufficient English for consent and interaction with the MyHeartMate app.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have a disorder which prevents them being able to interact with the MyHeartMate app or Facebook group, such as a diagnosed neurocognitive disorder or major visual impairment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be allocated to the intervention and control group following registration with the study coordinator based at the University and collection of baseline data (excluding MET-minutes). The study coordinator will use an online web-based random assignment tool (https://www.randomizer.org/) to generate the randomisation schedule. Allocation will be recorded by the study coordinator and the research assistant informed and action.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation using data from a text messaging intervention in cardiac patients22 indicates that in order to detect a difference in physical activity of 345 MET minutes/ week, using ANCOVA, with a pooled standard deviation of 1007.65, assuming 0.5 correlation between baseline and final outcome with a = 0.05 and power (1 - ß) = 0.95, the required sample size is 164 patients per group (total sample size: 328), including an additional 20% for drop out results in a total sample size of 394 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2017
Actual
16/10/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
20/02/2021
Date of last data collection
Anticipated
Actual
20/08/2021
Sample size
Target
394
Accrual to date
Final
394
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8039 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 11076 0
Westmead Hospital - Westmead
Recruitment hospital [3] 22813 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 22814 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 16079 0
2065 - St Leonards
Recruitment postcode(s) [2] 22882 0
2145 - Westmead
Recruitment postcode(s) [3] 38098 0
2065 - St Leonards
Recruitment postcode(s) [4] 38099 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 296485 0
University
Name [1] 296485 0
Charles Perkins Centre Innovator Fund
Country [1] 296485 0
Australia
Funding source category [2] 296505 0
Commercial sector/Industry
Name [2] 296505 0
Ramsay Health Research Fund
Country [2] 296505 0
Australia
Funding source category [3] 296506 0
Charities/Societies/Foundations
Name [3] 296506 0
Heart Foundation Vangard grant
Country [3] 296506 0
Australia
Primary sponsor type
Individual
Name
Professor Gemma Figtree
Address
Royal North Shore Hospital / The Kolling Institute of Medical Research
Reserve Rd
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 295466 0
None
Name [1] 295466 0
Address [1] 295466 0
Country [1] 295466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297707 0
Human Research Ethics Committee of the Northern Sydney Local Health District
Ethics committee address [1] 297707 0
Ethics committee country [1] 297707 0
Australia
Date submitted for ethics approval [1] 297707 0
12/05/2017
Approval date [1] 297707 0
03/07/2017
Ethics approval number [1] 297707 0
HREC/17/HAWKE/63
Ethics committee name [2] 300585 0
North Shore Private Hospital Ethics Committee
Ethics committee address [2] 300585 0
Ethics committee country [2] 300585 0
Australia
Date submitted for ethics approval [2] 300585 0
28/07/2017
Approval date [2] 300585 0
25/09/2017
Ethics approval number [2] 300585 0
NSPHEC 2017-009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74902 0
Prof Gemma Figtree
Address 74902 0
Department of Cardiology, Royal North Shore Hospital
Northern Clinical School, Kolling Institute of Medical Research
The University of Sydney
Royal North Shore Hospital
St Leonards NSW 2065
Country 74902 0
Australia
Phone 74902 0
+61 2 9926 7111
Fax 74902 0
Email 74902 0
gemma.figtree@sydney.edu.au
Contact person for public queries
Name 74903 0
Robyn Gallagher
Address 74903 0
Sydney Nursing School and Charles Perkins Centre, University of Sydney
Rm 2210, Level 2, The Hub D17
The University of Sydney
NSW 2007
Country 74903 0
Australia
Phone 74903 0
+61 2 86270279
Fax 74903 0
Email 74903 0
robyn.gallagher@sydney.edu.au
Contact person for scientific queries
Name 74904 0
Gemma Figtree
Address 74904 0
Department of Cardiology, Royal North Shore Hospital
Northern Clinical School, Kolling Institute of Medical Research
The University of Sydney
Royal North Shore Hospital
St Leonards NSW 2065
Country 74904 0
Australia
Phone 74904 0
+61 2 9926 7111
Fax 74904 0
Email 74904 0
gemma.figtree@sydney.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseDesign and rationale of the MyHeartMate study: A randomised controlled trial of a game-based app to promote behaviour change in patients with cardiovascular disease.2019https://dx.doi.org/10.1136/bmjopen-2018-024269
EmbaseUnderstanding and assessing gamification in digital healthcare interventions for patients with cardiovascular disease.2022https://dx.doi.org/10.1093/eurjcn/zvac048
N.B. These documents automatically identified may not have been verified by the study sponsor.