Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000408583
Ethics application status
Approved
Date submitted
19/03/2024
Date registered
4/04/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Avatar-based discharge education mobile application for Chinese-speaking patients with heart attacks
Scientific title
Efficacy of a culturally adapted avatar-based discharge education mobile application to improve disease knowledge and attendance at cardiac rehabilitation in Chinese-speaking patients after acute coronary syndrome (ACS)
Secondary ID [1] 311769 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular 333273 0
Condition category
Condition code
Cardiovascular 329967 329967 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an self-administered mobile application. This Mandarin version application was culturally adapted from the initial English version application, which is based on the Heart Foundation’s Six Steps to Cardiac Recovery'. During the adaptation process, bilingual clinicians and Chinese-speaking patients were heavily involved to ensure linguistic and cultural appropriateness, particularly, in the process of the storyboard translation and prototype development. For example, a number jokes used in the original English version were removed or replaced as they were not culturally appropriate for the Chinese.
Within the application, a Chinese-speaking avatar nurse talks and leads the patient through six modules of evidence-based essential information the Heart Foundation recommends for heart attack survivors and their families.
These six modules include:
1) understanding diagnosis/procedures,
2) knowing heart disease risk factors,
3) attending cardiac rehabilitation,
4) taking medications,
5) knowing warning signs and actions,
6) following ongoing medical review.
It will take approximately 40 minutes to complete six modules. The mode of training used in the intervention includes interactive activities and short videos.
In a single session of no more than 30 minutes, the researcher will assist participants in the intervention group to download and install the app on their personal smartphone or tablet before discharge and ensure participants are familiar with the app and its functions. Participants will have access to the app during the three months study period in addition to their usual care. Participants will have unlimited access to all the modules as many times as they like. Participants can go through the app in their own pace, which means that they do not need to complete all six modules in one attempt. Participants in the intervention groups are encouraged to contact the researcher if they experience any technical issues with the app during the study period.
Intervention code [1] 328222 0
Rehabilitation
Comparator / control treatment
The control group will receive usual hospital care, which includes usual discharge education, medical follow-up and rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 337728 0
Coronary heart disease knowledge
Timepoint [1] 337728 0
Baseline, one month and three months post-baseline
Primary outcome [2] 337815 0
Knowledge, attitude and belief of acute coronary syndrome
Timepoint [2] 337815 0
Baseline, one-month, three-months post-baseline
Secondary outcome [1] 432998 0
Cardiac-related hospital admission
Timepoint [1] 432998 0
One month and three months post-basedline
Secondary outcome [2] 433377 0
Healthcare utilisation
Timepoint [2] 433377 0
One month and three months post-baseline
Secondary outcome [3] 433378 0
Health-related quality of life
Timepoint [3] 433378 0
Three months post-baseline
Secondary outcome [4] 433379 0
Self-management behaviours
Timepoint [4] 433379 0
Three months post-baseline
Secondary outcome [5] 433382 0
App acceptability
Timepoint [5] 433382 0
One month post-baseline
Secondary outcome [6] 433383 0
App feasibility
Timepoint [6] 433383 0
Three months post-baseline
Secondary outcome [7] 433384 0
Barriers and facilitators of implementation
Timepoint [7] 433384 0
Three months post-baseline
Secondary outcome [8] 433560 0
Cardiac-related mortality
Timepoint [8] 433560 0
One month and three months post-baseline

Eligibility
Key inclusion criteria
Inclusion criteria:
1) >=18 years;
2) admitted to the participating hospitals with a diagnosis of ACS (unstable angina, myocardial infarction);
3) being discharged home;
4) speak Chinese (Mandarin); and
5) have a personal smartphone/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
Exclusion criteria:
1) critically unwell;
2) have severe co-existing medical conditions that would impede or prevent engagement in lifestyle behaviour change e.g. dementia or terminal illness
3) unable to give consent; and
4) unable to understand, speak or read basic Chinese.

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)
central randomisation computer
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316101 0
University
Name [1] 316101 0
University of Sydney - Faculty of Medicine and Health Bright Ideas Grant/China Studies Center Individual Research Project Support Grant
Country [1] 316101 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318269 0
None
Name [1] 318269 0
Address [1] 318269 0
Country [1] 318269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314928 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314928 0
Ethics committee country [1] 314928 0
Australia
Date submitted for ethics approval [1] 314928 0
18/01/2024
Approval date [1] 314928 0
11/03/2024
Ethics approval number [1] 314928 0
2024/ETH00110

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

Contacts
Principal investigator
Name 133162 0
Dr Ling Zhang
Address 133162 0
2W70, Level 2, Building D17, The University of Sydney, NSW, 2006
Country 133162 0
Australia
Phone 133162 0
+61 434209383
Fax 133162 0
Email 133162 0
[email protected]
Contact person for public queries
Name 133163 0
Ling Zhang
Address 133163 0
2W70, Level 2, Building D17, The University of Sydney, NSW, 2006
Country 133163 0
Australia
Phone 133163 0
+61 434209383
Fax 133163 0
Email 133163 0
[email protected]
Contact person for scientific queries
Name 133164 0
Ling Zhang
Address 133164 0
2W70, Level 2, Building D17, The University of Sydney, NSW, 2006
Country 133164 0
Australia
Phone 133164 0
+61 434209383
Fax 133164 0
Email 133164 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21890Study protocol  [email protected]
21891Informed consent form  [email protected]
21892Ethical approval  [email protected]



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.