Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000175673
Ethics application status
Approved
Date submitted
9/02/2023
Date registered
21/02/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
21/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Community-based cardiac rehabilitation for Chinese migrants in Australia
Scientific title
Community-based cardiac rehabilitation for Chinese migrants in Australia: A pilot randomised controlled trial
Secondary ID [1] 308969 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myocardial infarction 328983 0
heart failure 328984 0
coronary artery disease with recent revascularisation with coronary artery bypass graft (CABG) or coronary angioplasty/stenting 328985 0
Condition category
Condition code
Cardiovascular 325967 325967 0 0
Coronary heart disease
Cardiovascular 325968 325968 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given a community-based cardiac rehabilitation program for 24 weeks. This program was co-designed through a qualitative study by our research team, health care practitioners, Tai Chi instructors and patients from Chinese migrants. It includes health education via text messages, programmed Shared Medical Appointment, and online live Tai Chi class.

Participants will receive 4 messages per week (Monday to Friday between 9am to 5pm) for 24 weeks. The text message is semi-personalised, in simplified Chinese and traditional Chinese, covering topics of diet/nutrition, physical activity, smoking cessation, and general cardiac rehabilitation knowledge. Each message will take around 10 seconds to 40 seconds to read. For example, ‘[Preferred Name], research shows eating 2 serves of fruit & 5 serves of veggies reduces your risk of heart disease, stroke, diabetes & some cancers’. The messages will be semi-personalised. For example, only participants who are smokers will receive messages relevant to quitting smoking. The messages will be delivered by TextCare, a text message service developed by Westmead Applied Research Centre, University of Sydney by clinicians and researchers. It is a system that delivers customised messages to participants with their consent and provides a channel for communication, support, and education. The co-design process of the text messages included:
a. Selecting messages in English from an existing text messages bank in TextCare developed based on behaviour change techniques and national cardiac rehabilitation guidelines,
b. Refining messages according to the expert review including academics, clinicians, and Tai Chi instructors,
c. Translating text messages from English into simplified and traditional Chinese,
d. Conducting a community review via survey to collect consumer feedback,
e. Finalising Chinese message based on consumer feedback, and
f. Programming and pilot testing the delivery of text messages.

Participants will attend the one-off Shared Medical Appointment (SMA) group session and one-on-one session, which takes approximately up to 2 to 3 hours in total. The group session lasts 90 minutes. Participants will have 60 minutes with a cardiologist for consultation and 30 minutes with allied health practitioners (a dietitian and a physiotherapist) for general education in a group setting. In addition, participants will have additional one-on-one consultations with the nurse and allied health practitioners outside of the SMA group session. Each session lasts a maximum of 30 minutes. All sessions will be held after regular business hours on weekdays at 6pm (UTC+11) via zoom meetings. The sessions will be delivered in Mandarin (with Cantonese translation if necessary). All healthcare providers are familiar with the study design and be trained with the use of zoom meetings and the SMA approach.

Participants will attend online live Tai Chi class two times per week for 24 weeks. The class will be held on Tuesday and Thursday at 8am (UTC+11) via zoom meetings. Each class lasts 60 minutes. The contents include walking, standing posture, cloud hands and 6-form Chen-style Tai Chi. Class attendance will be recorded by the Tai Chi instructor in each class and reasons for missed sessions will be tracked by phone. Participants will be required to practice in an adequately spacious and safe place (at least 2 square meters) and guided by an experienced Tai Chi instructor with more than 15-year experience and two teaching assistants. Participants will receive instruction in self-monitoring during the practice. Close supervision will also be applied by the Tai Chi instructor and two teaching assistants. Participants are allowed to progress at their own pace, and have a rest when necessary, during the class. Participants are encouraged to practice at least three days outside of group class at home and record home practice in a participant diary. Home practice may take around 10 minutes to one hour daily depending on preference. Participants are encouraged to have a carer or helper nearby when doing Tai Chi practice at home. A WeChat group would be set up for participants in the intervention group to increase social support to participants and ensure timely feedback from the Tai Chi instructor and the teaching assistants to support participants’ home practice.
Intervention code [1] 325413 0
Rehabilitation
Comparator / control treatment
Participants assigned to the waitlist control will receive 2 text messages only – a welcome message after randomization and an exit message at the conclusion of the study thanking them for their involvement and reminder of outcome assessment. Participants in the waitlist control group will be encouraged to keep their normal lifestyle and physical activity. They will receive the same CR program after their 24-week wait period.
Control group
Active

Outcomes
Primary outcome [1] 333811 0
We use a composite of the following to define our feasibility measures:
• Recruitment rate: number of enquiries and number of enrolments per month of active recruitment; number enrolled with 6-month recruitment period; number enrolled divided by number of enquires; number randomised divided by number potentially eligible to the trial. The data will be collected via audit of trial records.
• Retention rate: number of completing the 24-week intervention and outcome measures, divided by the number enrolled. The data will be collected via audit of trial records.
• Adherence rate: number of completing SMA session and its additional one-on-one consultations, and attending at least 36 of 48 Tai Chi classes, divided by the total sessions allocated to the intervention group. The data will be collected via audit of trial records.
• Safety (adverse events): number of adverse events and severe adverse events during the
intervention. Adverse events will be assessed via participant self-report diary, Participants will be required to record any adverse events weekly in the participant diary, such as falls and muscle pain during physical activity or Tai Chi practice.
Timepoint [1] 333811 0
For recruitment rate, the number of enquiries, number of enrolments, time of enrolment, number potentially eligible to the trial, and number randomised will be recorded in the whole process of recruitment and randomisation, and calculated within 1 month after end of study.

For retention rate, number of completing the 24-week intervention and outcome measures will be calculated within 1 month after end of study.

For adherence rate, the number of participants in the intervention group who completed the one-off SMA group session, and its additional one-on-one consultations will be recorded once participant attended the sessions. The attendance of Tai Chi classes will be recorded by the Tai Chi instructor after each class. The retention rate will be calculated within 1 month after end of study.

For safety, participant self-report diary is collected weekly during the study. All adverse events will be recorded from the time a participant consents to join the study until the completion of the final follow-up.
Secondary outcome [1] 418381 0
• Economic appraisal: Chinese version of EQ-5D-5L
Timepoint [1] 418381 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [2] 418382 0
• Self-efficacy: Chinese version of the Cardiac Self-Efficacy Scale
Timepoint [2] 418382 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [3] 418383 0
• Social support: Chinese version of the Medical Outcomes Study Social Support Survey
Timepoint [3] 418383 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [4] 418384 0
• Physical activity: The distance and steps walked will be measured at baseline, week 12 and 24. The physical activity will be tracked for 7 days at each timepoint and monitor the distance and steps participants walked. Activity trackers (FitBit) will be delivered to participants by Australian Post, with a printed user manual in simplified and traditional Chinese. Instruction sessions will be held with participants via kit including an iHealth Connected Blood Pressure Monitor, an iHealth Lite Wireless Scale, and an iHealth wireless PO3M pulse oximeter, will be delivered to each participant by Australian Post, with a printed user manual in simplified and traditional Chinese. The manual is developed by the research team based on the English version of iHealth official manuals, simplified to be user-friendly, and translated into Chinese version. The manual includes how to use the iHealth application to sync the results to iHealth Cloud Database and how to use the devices provided.
Timepoint [4] 418384 0
Baseline, 12 weeks and 24 weeks after commencing treatment. The distance and steps will be tracked for 7 days at each timepoint.
Secondary outcome [5] 418385 0
Fasting plasma glucose and insulin, Hba1c, blood lipids including high density lipoprotein (HDL), low density lipoprotein (LDL), triglyceride (TG), and total cholesterol. Participants will be provided electronic referral letters by researchers to conduct the pathology tests at their local Laverty Pathology.
Timepoint [5] 418385 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [6] 418386 0
Quality of life measured by EQ-5D-5L
Timepoint [6] 418386 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [7] 418387 0
Self-reported health behaviour change (diet, smoking, etc.) measured by participant diary
Timepoint [7] 418387 0
Weekly during the 24-week study treatment period
Secondary outcome [8] 418388 0
Satisfaction: Semi-structured exit interviews will be conducted at the end of the trial to understand the experience of the trial procedure and satisfaction of the cardiac rehabilitation program. All participants will be invited to take part in the interview via Zoom meeting when they completed or withdrew from the study. A trained research assistant will facilitate the interviews. Each one-on-one interview will last around 30 minutes.
Timepoint [8] 418388 0
Within 1 month after end of study
Secondary outcome [9] 418780 0
Stress measured by Chinese version of Depression Anxiety Stress Scale (DASS 21)
Timepoint [9] 418780 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [10] 418781 0
Anxiety measured by Chinese version of Depression Anxiety Stress Scale (DASS 21)
Timepoint [10] 418781 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [11] 418782 0
Depression measured by Chinese version of Depression Anxiety Stress Scale (DASS 21)
Timepoint [11] 418782 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [12] 418783 0
MacNew Heart Disease Health-related Quality of Life Questionnaire
Timepoint [12] 418783 0
Baseline, 12 weeks and 24 weeks after commencing treatment
Secondary outcome [13] 428236 0
The Caregiver Indirect and Informal Care Cost Assessment Questionnaire
Timepoint [13] 428236 0
Baseline, 12 weeks and 24 weeks after commencing treatment

Eligibility
Key inclusion criteria
• Aged 18 years old or above.
• Are an Australian citizen or permanent resident.
• Are of Chinese ancestry, speak Mandarin or Cantonese at home,
and can read Chinese (traditional or simplified).
• Experienced at least one of the following conditions or events:
o myocardial infarction,
o heart failure, or
o coronary artery disease with recent revascularisation with
coronary artery bypass graft (CABG), or coronary
angioplasty/stenting.
• Being discharged home for at least 12 weeks.
• Are willing and able to give written informed consent.
• Have a mobile phone and the capacity to receive and understand
text messages.
• Have access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
• have being diagnosed cognitive impairment or terminal illness by
a medical doctor,
• are regular Tai Chi practitioner or have practiced Tai Chi within 3
months,
• are enrolled in another active research project, or
• new (within the last 8 weeks) symptoms of breathlessness, chest
discomfort, palpitation, syncope, or presyncope, documented
change in resting ECG, uncontrolled resting hypertension (systolic
BP > 180mmHg and/or diastolic BP > 110mmHg);
• have any orthopaedic limitations that would significantly limit
exercise participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation and allocation concealment will be achieved by REDCap. The allocation will be concealed from all study personnel (except the study REDCap programmer), including the investigators and participants. It will not be possible to predict or decipher the next allocation because the sequence will be uploaded to REDCap, accessed and maintained by the REDCap programmer with specific user rights, so that both key study staff and participants would not have access to the sequence and will be blinded to group allocation. The randomisation records will be maintained in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into the treatment group and the waitlist control group at a 1:1 ratio using random number sequence generated by an independent statistician and uploaded to the Research Electronic Data Capture (REDCap) software, a secure, browser-based web application, by the study REDCap programmer. An independent REDCap programmer will set up the randomisation module in REDCap and generate the allocation results.
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
24/02/2023
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
24
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313184 0
University
Name [1] 313184 0
Western Sydney University (Research Support Program Fellowship)
Country [1] 313184 0
Australia
Funding source category [2] 313185 0
University
Name [2] 313185 0
Western Sydney University (Early Career Researcher Fellowship)
Country [2] 313185 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith, NSW 2751
Country
Australia
Secondary sponsor category [1] 314894 0
None
Name [1] 314894 0
Address [1] 314894 0
Country [1] 314894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312419 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 312419 0
Locked Bag 1797, Penrith, NSW 2751
Ethics committee country [1] 312419 0
Australia
Date submitted for ethics approval [1] 312419 0
30/01/2023
Approval date [1] 312419 0
30/01/2023
Ethics approval number [1] 312419 0
H15154

Summary
Brief summary
This is a 24-week pilot randomised controlled trial of a community-based cardiac rehabilitation (CR) program for Chinese migrants in Australia. A total of 24 participants will be randomly allocated in a 1:1 ratio to the intervention or waitlist control group.

People in the intervention group will be offered a CR program virtually in entirety for 24 weeks, including health education via text messages, Shared Medical Appointment (SMA), and online live Tai Chi. Participants in the waitlist control group will be given no intervention during their wait period and will be encouraged to keep their normal lifestyle and physical activity. They will receive the same CR program after their wait period.

The objectives of this project are:
(1) To assess the feasibility of the co-designed community-based CR program for Chinese migrants in Australia of a wider trial by measuring its adoption rate.
(2) To examine the effects of the co-designed CR program on improving health outcomes among cardiac patients from Chinese migrants in Australia.
(3) To explore the cost effectiveness of the community-based co-designed CR program for Chinese migrants in Australia.

The expected outcomes of this pilot randomised controlled trial include:
• This pilot randomised controlled trial will quantify the feasibility, cost-effectiveness, and
effectiveness of the co-designed, culturally sensitive community-based CR program.
• The findings from this pilot trial will be interpreted as indicators of the potential value of a fully powered randomised controlled trial and other implementation and cost-effectiveness studies for CR among Chinese migrants in Australia and other western countries.
Trial website
https://www.westernsydney.edu.au/nicm/research/clinical_trials/cardiac_rehabilitation_program_for_chinese_migrants_in_australia
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124594 0
Dr Guoyan Yang
Address 124594 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith, NSW 2751
Country 124594 0
Australia
Phone 124594 0
+61 2 9685 4732
Fax 124594 0
Email 124594 0
e.yang@westernsydney.edu.au
Contact person for public queries
Name 124595 0
Dr Guoyan Yang
Address 124595 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith, NSW 2751
Country 124595 0
Australia
Phone 124595 0
+61 2 9685 4732
Fax 124595 0
Email 124595 0
e.yang@westernsydney.edu.au
Contact person for scientific queries
Name 124596 0
Dr Guoyan Yang
Address 124596 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith, NSW 2751
Country 124596 0
Australia
Phone 124596 0
+61296854732
Fax 124596 0
Email 124596 0
e.yang@westernsydney.edu.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 underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal, or for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator (e.yang@westernsydney.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18320Ethical approval  e.yang@westernsydney.edu.au
18321Informed consent form  e.yang@westernsydney.edu.au 385384-(Uploaded-09-02-2023-17-32-51)-Study-related document.pdf



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.