Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001436763
Ethics application status
Approved
Date submitted
3/11/2022
Date registered
9/11/2022
Date last updated
5/09/2023
Date data sharing statement initially provided
9/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an Avatar App on Knowledge and Behaviour after Heart Attack
Scientific title
Effect of an Avatar-Based Discharge Education Application on Knowledge and Behaviour in People after Acute Coronary Syndrome
Secondary ID [1] 308320 0
None
Universal Trial Number (UTN)
U1111-1284-5063
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 328104 0
Condition category
Condition code
Cardiovascular 325157 325157 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Avatar Cardiac Recovery App was co-designed and tested in a feasibility study of 22 participants by a group led by Dr Ling Zhang at the University of Sydney. https://doi.org/10.1016/j.hlc.2022.06.017

Prior to discharge from hospital, a researcher will approach participants on the ward and provide a link and password for them to download the app to their personal smart phone or tablet. This app contains six modules that provide self-delivered education based on the Australian Heart Foundation's Six Steps to Cardiac Recovery:
1. Explain diagnosis / procedure
2. Highlight risk factors relevant to the patient. Smoking, physical activity, nutrition, weight, alcohol, blood pressure, cholesterol, diabetes and emotional health are discussed.
3. Emphasise importance of cardiac rehabilitation and ensure the patient understands activity and exercise guidelines
4. Promote medication adherence
5. Education on warning signs of a heart attack and managing heart attack symptoms
6. Encourage follow up with a doctor.
The modules contain videos, animations, games and education from an avatar that mimics a real person's voice, facial expressions and gestures. It is anticipated these features may be more suitable and engaging than written information, especially for people with poor literacy skills.
Participants will be encouraged to independently complete all six modules over the three-month study period. Participants will be encouraged to repeat modules that directly relate to their goals or individual risk factors. Each module concludes with questions about users' understanding of the content. Approximately 40 minutes is required to complete all the modules but participants can work through them at their own pace.
Intervention fidelity will be assessed from analytical data built into the app's software including time spent in the app and number of modules completed.
Intervention code [1] 324769 0
Treatment: Other
Comparator / control treatment
The intervention group will be compared to usual care.
Usual care:
Electronic referrals are sent to the cardiac rehabilitation team who contact the patient on the ward prior to discharge and provide a pamphlet about the local rehabilitation service. Additionally, staff screen ward admission lists 1-2 times per week for additional candidates. Participants are encouraged to attend cardiac rehabilitation as part of usual care, which usually commences 1-2 weeks after discharge and continues for up to 12 weeks. Cardiac rehabilitation staff will remain blinded to group allocation.

All participants will be contacted during week three of their enrolment in the study. The usual care group will receive a courtesy message reminding them of their follow up appointment, and participation in the study, and the intervention group will be sent a reminder to engage with the app.
Control group
Active

Outcomes
Primary outcome [1] 332982 0
Change in coronary heart disease knowledge measured using the Coronary Artery Disease Education Questionnaire II.
Timepoint [1] 332982 0
Baseline and three months after randomisation.
Secondary outcome [1] 415412 0
Change in knowledge, attitudes and beliefs about heart attack symptoms and response will be measured using the ACS Response Index.
Timepoint [1] 415412 0
Baseline and three months after randomisation.
Secondary outcome [2] 415413 0
Change in health-related quality of life will be measured using the five level EuroQol five dimension instrument (EQ-5D_5L).
Timepoint [2] 415413 0
Baseline and three months after randomisation.
Secondary outcome [3] 415415 0
Response to heart attack symptoms will be assessed via a study-developed questionnaire based on the Heart Foundation’s Heart Attack Action Plan to "Stop, Talk, Take and Call”.
Timepoint [3] 415415 0
Three months after randomisation.
Secondary outcome [4] 415424 0
Readmissions to the Emergency Department for a cardiovascular event or heart attack symptoms will be collected via self report using a study-specific survey and review of the medical record.
Timepoint [4] 415424 0
Three months after randomisation.
Secondary outcome [5] 415425 0
Cardiovascular-related mortality will be obtained from review of the medical record.
Timepoint [5] 415425 0
Three months after randomisation.
Secondary outcome [6] 415426 0
Attendance and completion of cardiac rehabilitation (including number of sessions attended) will be assessed descriptively by self report using a study-specific survey and cross-checked with their medical record.
Timepoint [6] 415426 0
Three months after randomisation.
Secondary outcome [7] 415427 0
Health care utilisation or health-seeking behaviours targeting cardiovascular risk factors (e.g., regular planned visits to the GP, Chronic Disease Management plan from the GP or enrolment in a health coaching service or weight loss program) - assessed via a study-developed survey and Medicare Benefits Scheme (MBS) data in their medical record.
Timepoint [7] 415427 0
Three months after randomisation.
Secondary outcome [8] 415429 0
Change in medication awareness and adherence will be assessed descriptively by participant self-report using a study-specific survey questioning how many pills they missed in the previous 7 days and calculating the proportion of days covered. This will also be cross referenced with Pharmaceutical Benefits Scheme (PBS) data in their medical record.
Timepoint [8] 415429 0
Baseline and three months after randomisation.
Secondary outcome [9] 415430 0
Change in smoking behaviour will be assessed descriptively by participant self-report of their current smoking status using a study-specific survey.
Timepoint [9] 415430 0
Baseline and three months after randomisation.
Secondary outcome [10] 415431 0
Change in physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ).
Timepoint [10] 415431 0
Baseline and three months after randomisation.
Secondary outcome [11] 415432 0
Participants assigned to the intervention group will be invited to complete a user-survey to determine acceptability and satisfaction with the intervention and any modifications required for ongoing use. Participants will be asked a series of questions using a Likert scale and free responses relating to their use of the app, and how satisfied they are with the content, usability and features of the app.
Timepoint [11] 415432 0
The user-survey has been moved forward and will be completed one month after randomisation only.
Secondary outcome [12] 419648 0
Cumulative time spent in each module, number of log-ins, and number of modules completed for each user: a report will be generated by the research team (based on participants’ unique app ID) using data captured by Google Analytics. Data on use of the app before and after the reminder message will be compared.
Timepoint [12] 419648 0
Three month follow-up

Eligibility
Key inclusion criteria
- Adults admitted to Westmead Hospital under Cardiology or Cardiothoracic Surgery with a diagnosis of ACS (unstable angina, non-ST elevated myocardial infarction (NSTEMI) or ST-elevated myocardial infarction (STEMI)) in the current admission or previous 3 months, including patients returning to hospital for revascularization procedures including Coronary Artery Bypass Grafting (CAGB) or Percutaneous Coronary Intervention (PCI).
- Are being discharged home
- Have access to their personal smart phone or tablet, which has software capable of downloading the app
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Critically unwell
- Severe co-existing medical conditions that would impede or prevent engagement in lifestyle behaviour change e.g. dementia or terminal illness
- Unable to give consent
- Unable to understand, speak or read basic English

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)
A concealed allocation sequence uploaded to REDCap will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
64 participants will be required to detect a between-group difference in CADE-Q II score of 9.5 points (a = 0.05, 80% power), based on a similar study in a cohort of 115 people with ACS comparing wait list controls with comprehensive cardiac rehabilitation. To account for 10% loss to follow-up, the aim is to recruit 72 participants.

For the primary outcome, within-group comparisons will be analysed using paired t-tests. Between-group comparisons and 95% confidence intervals (CIs) will be analysed using analysis of covariance (ANCOVA) with baseline values for each respective outcome entered into the model as a continuous covariate. Continuous secondary outcomes will be analysed similarly. Prescribed medications will be calculated as a proportion of the five preventive pharmacotherapies. If prescribed any of the five preventative pharmacotherapies, medication adherence will be calculated as a proportion of the preventative pharmacotherapies taken in the past 7 days, using ordinal logistic regression, adjusting for the baseline value. For categorical secondary outcomes, within-group comparisons will be analysed using Pearson Chi-Square and between-group comparisons using nominal logistic regression with adjustment for baseline values. Between-group comparisons in hospital readmissions, cardiovascular-related mortality, cardiac rehabilitation attendance and health care utilisation will be analysed using log-binomial regression. Uptake, retention and engagement with the intervention, participant compliance and module completion will be analysed descriptively. Adverse events, time spent supporting participants, and reasons for non-uptake and non-completion of the app will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
26/04/2023
Date of last participant enrolment
Anticipated
26/04/2024
Actual
Date of last data collection
Anticipated
26/07/2024
Actual
Sample size
Target
72
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23485 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 38893 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 312600 0
Hospital
Name [1] 312600 0
Westmead Hospital
Country [1] 312600 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Level 6, Block K,
Cnr Hawkesbury Road and Darcy Road,
Westmead Hospital
Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 314176 0
Hospital
Name [1] 314176 0
Westmead Hospital
Address [1] 314176 0
PO Box 533 Wentworthville NSW 2145
Country [1] 314176 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311891 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311891 0
WSLHD Research and Education Network
Cnr Hawkesbury Road and Darcy Road Westmead NSW 2145
Ethics committee country [1] 311891 0
Australia
Date submitted for ethics approval [1] 311891 0
07/10/2022
Approval date [1] 311891 0
27/02/2023
Ethics approval number [1] 311891 0

Summary
Brief summary
Avatar-delivered education via an app is a novel approach to assist health care workers provide good quality education to adults after heart attack during the hospital admission, and may be more suitable than traditional written materials for adults with poor literacy. The app contains six modules based on the Heart Foundation’s Six Steps to Cardiac Recovery. This study will compare the app to usual care in a randomised, controlled trial. Study outcomes will include change in knowledge, attitude and beliefs around heart disease, change in quality of life, health care utilisation, response to heart attack symptoms and impact on heart disease risk factors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122738 0
Prof Julie Redfern
Address 122738 0
Faculty of Medicine and Health
The University of Sydney
Level 6, Block K
Westmead Hospital, Westmead, NSW 2145
Country 122738 0
Australia
Phone 122738 0
+61 2 8890 6787
Fax 122738 0
Email 122738 0
julie.redfern@sydney.edu.au
Contact person for public queries
Name 122739 0
Mrs Tiffany Ellis
Address 122739 0
Westmead Hospital,
Cnr Hawkesbury Road and Darcy Road
Westmead NSW 2145
PO Box 533, WENTWORTHVILLE NSW 2145
Country 122739 0
Australia
Phone 122739 0
+61 2 8890 6501
Fax 122739 0
Email 122739 0
tiffany.sorial@health.nsw.gov.au
Contact person for scientific queries
Name 122740 0
Mrs Tiffany Ellis
Address 122740 0
Westmead Hospital,
Cnr Hawkesbury Road and Darcy Road
Westmead NSW 2145
PO Box 533, WENTWORTHVILLE NSW 2145
Country 122740 0
Australia
Phone 122740 0
+61 2 8890 6501
Fax 122740 0
Email 122740 0
tiffany.sorial@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, with no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Data access will be subject to approval by the Principal investigator who can be contacted via email: robert.zecchin@health.nsw.gov.au


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.