Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000724471
Ethics application status
Approved
Date submitted
12/06/2025
Date registered
8/07/2025
Date last updated
8/07/2025
Date data sharing statement initially provided
8/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A multisite, randomised, controlled, single-blind trial of a personalised digital health intervention for post-discharge cardiology patients
Scientific title
CARDIOvascular support for patients after disCHARGE (CARDIOCHARGE):
A nationwide, multicentre, (hybrid) implementation-effectiveness trial
Secondary ID [1] 313432 0
Nil
Universal Trial Number (UTN)
Trial acronym
CARDIOCHARGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 335804 0
Condition category
Condition code
Cardiovascular 332383 332383 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 332384 332384 0 0
Other cardiovascular diseases
Cardiovascular 332382 332382 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study A (Effectivness Testing):
Study A is an individually-randomised trial comprised of two parallel arms (i.e. Treatment and Control arms). The digital health intervention (DHI) comprises a 6-month program of education, support and guidance customised to patients’ cardiovascular condition, socio-demographics and preferences and delivered primarily via text-messages and complimented with multi-channel digital communication (via App, web-links, email).

The DHI program is designed to support patients who have had a cardiovascular hospitalisation after being discharged. The program content aims to provide information, support and a line of connection for patients to healthcare providers for 6 months. These will encourage patients to optimise their cardiovascular risk factor control, adhere to their treatments, follow-up with their healthcare providers and improve their self-efficacy in managing their cardiovascular health. The content will be aligned with clinical guidelines, approved by clinicians and localised to local services and community. Participants will receive up to 5 messages a week for 26 weeks.

Content areas include: General heart health, smoking cessation, diet & nutrition, physical activity, coronary heart disease, heart failure, atrial fibrillation, implated cardiac devices. Each text message is less than 300 characters with some messages containing links to additional information which is optional to review. A brief example of content that may be shared is: "After a heart heart attack, most people are prescribed two antiplatelet medicines. This is aspirin plus one other blood thinning medicine. Both are very important to prevent the blood vessel from blocking up again. Speak to your doctor for more info."

Study B (Implementation Testing):
At the outset, all participants enrolled in Study A will also be enrolled in Study B. Study B is a cluster crossover trial (where each site comprises a cluster) that will test whether an additional pone call improves participant recruitment to join the DHI program described above (Study A). Clusters are randomised to one of 2 sequences (each lasting 12 weeks): Sequence 1 (Treatment period [6 weeks] followed by Control Period [6 weeks]), OR Sequence 2 (Control Period [6 weeks] followed by Treatment period [6 weeks]). Study A and Study B will begin simultaneously.

All patients (both Study B Control and Treatment groups) being discharged from cardiovascular services will receive a text message and SMS reminders soon after leaving the hospital. These will be about the digital discharge support program provided by the Cardiology department of the relevant hospital.

In addition to these, participants recruited during Study B’s Treatment Period will also receive a telephone call within a week of discharge, detailing the program. If the patient is not contactable, the staff member responsible will attempt to call them a total of three times in the ensuing week following the first call. During this telephone call with a study staff member, participants will be offered the option to consent over the phone, stepped through the consent process and multi-factor verification for program enrolment and asked to answer a few additional questions to customise the content. We will assess adherence through self-report and interaction with digital platform including engagement metrics.
Intervention code [1] 329998 0
Behaviour
Intervention code [2] 329996 0
Rehabilitation
Intervention code [3] 329997 0
Lifestyle
Comparator / control treatment
Study A (Effectivness Testing):
The control group will be sent a single text message containing a hyperlink to a PDF document/website containing a single bundle of standard post-discharge information and instructions which are representative of the current standard of care (as opposed to the 6-month intervention described in treatment group).

Study B (Implementation Testing):
All patients being discharged from cardiovascular services will receive a text message and SMS reminders soon after leaving the hospital. These will be about the digital discharge support program provided by the Cardiology department of the relevant hospital. Participants recruited during Study 2B’s Control Period will receive only these messages. In Study B, clusters are randomised to one of 2 sequences (each lasting 12 weeks): Sequence 1 (Treatment period [6 weeks] followed by Control Period [6 weeks]), OR Sequence 2 (Control Period [6 weeks] followed by Treatment period [6 weeks]).
Control group
Active

Outcomes
Primary outcome [1] 339941 0
Study B (Implementation): Enrolment/Opt-in rate • Among all invited participants • Among specified diverse subgroups (e.g. gender, age, health literacy, CALD groups).
Timepoint [1] 339941 0
Study B (Implementation): At the conclusion of the enrolment period
Primary outcome [2] 339940 0
Study A (Effectiveness): Re-hospitalization rate (All-cause) at 6 months
Timepoint [2] 339940 0
Study A (Effectiveness): Baseline and 1 week following end of intervention
Secondary outcome [1] 442012 0
Study A (Effectiveness): Mortality rate
Timepoint [1] 442012 0
Study A (Effectiveness): 1 week following end of intervention
Secondary outcome [2] 442014 0
Study A (Effectiveness): Risk factor control (diet, physical activity, smoking, BP, cholesterol)
Timepoint [2] 442014 0
Study A (Effectiveness): Risk factor control at baseline and 1 week following end of intervention
Secondary outcome [3] 442040 0
Study A (Effectiveness): Motivation to change behaviour
Timepoint [3] 442040 0
1 week following end of intervention
Secondary outcome [4] 442039 0
Study A (Effectiveness): Medical adherence
Timepoint [4] 442039 0
1 week following end of intervention
Secondary outcome [5] 449345 0
Study B (Implementation): Variation in DH intervention reach
Timepoint [5] 449345 0
Following end of recruitment
Secondary outcome [6] 442016 0
Study A (Effectiveness): Self-efficacy
Timepoint [6] 442016 0
Study A (Effectiveness): 1 week following end of intervention
Secondary outcome [7] 442010 0
Study A (Effectiveness): Re-hospitalization rate (CVD) at 6 months, 12 months, 3 years
Timepoint [7] 442010 0
Study A (Effectiveness): Baseline and 1 week following end of intervention
Secondary outcome [8] 449347 0
Study B (Implementation): Variation in DH intervention retention of engagement
Timepoint [8] 449347 0
Following end of intervention
Secondary outcome [9] 442013 0
Study A (Effectiveness): Length of hospital stay
Timepoint [9] 442013 0
Study A (Effectiveness): 1 week following end of intervention
Secondary outcome [10] 442015 0
Study A (Effectiveness): Health literacy
Timepoint [10] 442015 0
Study A (Effectiveness): 1 week following end of intervention
Secondary outcome [11] 442059 0
Study B (Implementation): Variation in DH intervention uptake
Timepoint [11] 442059 0
Following end of recruitment
Secondary outcome [12] 442011 0
Study A (Effectiveness): ED re-presentation rate (All-cause & CVD) at 6 months, 12 months and 3 years
Timepoint [12] 442011 0
Study A (Effectiveness): Baseline and 1 week following end of intervention
Secondary outcome [13] 448658 0
Study A (Effectiveness): Re-hospitalization rate (All-cause) at 12 months, and 3 years
Timepoint [13] 448658 0
Study A (Effectiveness): Baseline and 1 week following end of intervention
Secondary outcome [14] 442056 0
Study B (Implementation): Program completion rate
Timepoint [14] 442056 0
Following end of intervention
Secondary outcome [15] 449346 0
Study B (Implementation): Variation in DH intervention adoption
Timepoint [15] 449346 0
Following end of intervention
Secondary outcome [16] 442058 0
Study B (Implementation): Participant engagement with intervention
Timepoint [16] 442058 0
Following end of intervention

Eligibility
Key inclusion criteria
We will include adult patients with a primary cardiovascular diagnosis at participating trial sites (including both elective and unplanned admissions), including patients who are:
- Admitted to cardiology wards;
- Admitted to non-cardiology wards (e.g. general medicine or geriatrics) for whom a cardiology consult is requested;
- Accessing cardiovascular care services such as presenting at a Rapid Access Cardiology Clinic (RACC) at participating trial site.
Participants not meeting the inclusion criteria will be excluded.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Central randomisation by computer software (i.e. computerised sequence generation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Hybrid implementation-effectiveness study with implementation testing starting at onset of effectiveness testing,
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study A (Effectiveness testing): A log binomial regression model on the outcome of whether a patient re-hospitalised within 6 months will be used to compare the treatment groups, adjusted for hospital and opt in approach. The relative risk and 95% confidence interval will be presented.

Study B (Implementation Testing): Equity of adoption and reach
To examine equitable achievement of adoption, reach and effectiveness we will ensure we collect information at site and for participants that enable analysis for subgroups:
- Age (i.e. among older and younger people)
- Gender
- Linguistic (non-English and English-speaking backgrounds),
- Sociocultural background (ATSI, CALD groups. Etc.).
Clinical outcome data will be obtained through health record data linkage, leveraging existing expertise and partnerships. We will conduct linked data analyses to examine impact across diverse (specified) sub-groups, and evaluate the reach of the DHI across diverse groups (e.g. disease type, gender, age, literacy, CALD groups). A mixed log binomial regression model on the outcome of whether a patient opted out of the treatment program will be used to assess the effectiveness of the two recruitment interventions with a random effect for site.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 317868 0
Government body
Name [1] 317868 0
National Health and Medical Research Council, MRFF Cardiovascular Health Mission Grant (2023 round)
Country [1] 317868 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321138 0
None
Name [1] 321138 0
Address [1] 321138 0
Country [1] 321138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316547 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316547 0
Ethics committee country [1] 316547 0
Australia
Date submitted for ethics approval [1] 316547 0
14/11/2024
Approval date [1] 316547 0
14/03/2025
Ethics approval number [1] 316547 0
2024/ETH02397

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

Contacts
Principal investigator
Name 138230 0
Prof Clara K Chow
Address 138230 0
Level 5, Block K Westmead Hospital 176 Hawkesbury Road Westmead, NSW 2145
Country 138230 0
Australia
Phone 138230 0
+61 401 754 572
Fax 138230 0
Email 138230 0
[email protected]
Contact person for public queries
Name 138231 0
Clara K Chow
Address 138231 0
Level 5, Block K Westmead Hospital 176 Hawkesbury Road Westmead, NSW 2145
Country 138231 0
Australia
Phone 138231 0
+61 02 9852 5222
Fax 138231 0
Email 138231 0
[email protected]
Contact person for scientific queries
Name 138232 0
Clara K Chow
Address 138232 0
Level 5, Block K Westmead Hospital 176 Hawkesbury Road Westmead, NSW 2145
Country 138232 0
Australia
Phone 138232 0
+61 02 9852 5222
Fax 138232 0
Email 138232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Insitutional policies on data sharing



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.