Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000867493
Ethics application status
Approved
Date submitted
3/06/2025
Date registered
11/08/2025
Date last updated
11/08/2025
Date data sharing statement initially provided
11/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Transforming outcomes for heart failure in Australia SMART: Self-Management And Remote Technologies.
Scientific title
Digital-enabled solutions to support healthcare delivery: Transforming outcomes for heart failure in Australia (SMART; Self-Management And Remote Technologies)
Secondary ID [1] 314591 0
None
Universal Trial Number (UTN)
Trial acronym
SMART: Self-Management And Remote Technologies
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 337706 0
Condition category
Condition code
Cardiovascular 334042 334042 0 0
Other cardiovascular diseases
Public Health 334221 334221 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with the SMART system (wearables and tablet) free of charge to use for the duration of the intervention (90-days). A researcher/technical support staff will be available to assist with set-up and provide technical support as required.
The SMART model of delivery will involve a heart failure nurse meeting the person living with heart failure (and their carer, if available) to develop a care plan, assess community support, identify gaps, and initiate SMART. They will outline how to establish a program of home surveillance (e.g., review of symptoms, weight, and vital signs), respond to the system and initiate the care plan. With the help of SMART, participants will be requested to record daily measurements of weight and blood pressure, answer questions about their symptoms, and to act in response to any changes. The behavioural goal is adherence to prescribed self-care activities.
Provided devices will be Withings Smart Watch, Withings Blood Pressure monitor, Withings Scales and a tablet. Participants will engage with these devices for approximately 15-20 minutes per day to record their weight, blood pressure, fluid intake, medications and any symptoms they may be experiencing. Data collected will be monitored by the Deakin study staff. Any adverse symptoms recorded will alert the Cardiology nurse via email who can then reach out to the participant to discuss. Care plan will be as prescribed by the participants cardiologist. This study is providing daily monitoring to improve adherence and outcomes.
Intervention code [1] 331216 0
Behaviour
Comparator / control treatment
Control participants will be Active controls undergoing Usual Care. They will have access to their usual cardiology and general practice care. only. Usual care is deemed as routine support, which may also include the hospital admission risk program (HARP). The Control group will not be given access to SMART System
Control group
Active

Outcomes
Primary outcome [1] 341704 0
Recruitment and Attrition. This will be assessed as a composite outcome.
Timepoint [1] 341704 0
Post intervention (90days)
Primary outcome [2] 341705 0
Engagement
Timepoint [2] 341705 0
Daily during intervention.
Primary outcome [3] 341706 0
Objective measure Physical Activity
Timepoint [3] 341706 0
Daily during intervention
Secondary outcome [1] 448442 0
Hospital readmissions
Timepoint [1] 448442 0
After the 90 day intervention or control period is completed, recruitment sites will send through a report of any hospital readmissions that occurred during the 90day Intervention or control period.
Secondary outcome [2] 448443 0
Heart-failure related mortality
Timepoint [2] 448443 0
After the 90 day intervention or control period is completed, recruitment sites will send through a report of any heart-failure related mortality that occurred during the 90day Intervention or control period.
Secondary outcome [3] 448858 0
This is an additional Primary outcome Objective measure - medication adherence
Timepoint [3] 448858 0
Daily during intervention
Secondary outcome [4] 448859 0
This is an additional Primary outcome Objective measure - recording daily symptoms
Timepoint [4] 448859 0
Daily during intervention
Secondary outcome [5] 450340 0
This is an additional Composite Primary outcome Objective measure - self weighing, blood pressure.
Timepoint [5] 450340 0
Daily during Intervention

Eligibility
Key inclusion criteria
Adults (aged 18 years or more) with a documented clinical diagnosis of heart failure, access to the internet, and ability to read and understand English language (for informed consent purposes) will be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with severe symptoms (persistent New York Heart Association IV), MI or unstable angina following intervention by Percutaneous Coronary Intervention (PCI) (less than 30 days or Coronary Artery Bypass Grafting (CABG) less than 60 days, unrevascularised coronary artery disease (CAD) with Chronic Coronary Syndrome (CCS) class III and IV, patients referred to a cardiac transplant unit, and patients with palliative intent.
Individuals living in a long-term care establishment (e.g., care home), are planning to be away from home for 4 or more weeks during the intervention; or have any other disorder of such severity that life expectancy is less than 12 months.

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 phone/fax/computer. REDCap database
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). Stratified by recruitment site and by sex.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
QUANTITATIVE DATA
Analyses will be conducted on an intention-to-treat basis. Descriptive statistics (Means and SD for continuous data and N % for categorical) will be presented for all quantitative data. Generalised linear models (e.g., logistic for binary outcomes) will be fitted to estimate intervention effects for quantitative primary (30-day and 90-day admissions) and secondary (e.g., self-care behaviours, HRQoL) outcomes. Point estimates and 95% confidence intervals (CIs) of intervention effects will be reported.
Qualitative data
All qualitative data will be transcribed verbatim. NVivo software will be used to facilitate data coding and analysis. We will read and reread the data, noting down initial ideas.
1) Generating initial codes: Coding interesting features of the data in a systematic fashion across the entire data set, collating data relevant to each code.
2) Searching for themes: Collating codes into potential themes, gathering all data relevant to each potential theme.
3) Reviewing themes: Checking if the themes work in relation to the coded extracts and the entire data set, generating a thematic ‘map’ of the analysis.
4) Defining and naming themes: Ongoing analysis to refine the specifics of each theme, and the overall story the analysis tells, generating clear definitions and names for each theme.
5) Producing the report: Selection of vivid, compelling extract examples, final analysis of selected extracts, relating back of the analysis to the research question and existing literature.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2027
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 28002 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 28003 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 28004 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [4] 28005 0
East Grampians Health Service - Willaura campus - Willaura
Recruitment postcode(s) [1] 44204 0
3084 - Heidelberg
Recruitment postcode(s) [2] 44205 0
4029 - Herston
Recruitment postcode(s) [3] 44206 0
3550 - Bendigo
Recruitment postcode(s) [4] 44207 0
3379 - Willaura

Funding & Sponsors
Funding source category [1] 319138 0
Government body
Name [1] 319138 0
Australian Government Department of Health, Disability and Ageing - Cardiovascular Health Mission - Medical Research Future Fund
Country [1] 319138 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 321604 0
None
Name [1] 321604 0
Address [1] 321604 0
Country [1] 321604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317731 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 317731 0
Ethics committee country [1] 317731 0
Australia
Date submitted for ethics approval [1] 317731 0
24/02/2025
Approval date [1] 317731 0
24/03/2025
Ethics approval number [1] 317731 0
HREC/76317/MH-2021

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

Contacts
Principal investigator
Name 141962 0
Prof Ralph Maddison
Address 141962 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 141962 0
Australia
Phone 141962 0
+61 392446218
Fax 141962 0
Email 141962 0
[email protected]
Contact person for public queries
Name 141963 0
Ralph Maddison
Address 141963 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 141963 0
Australia
Phone 141963 0
+61 392446218
Fax 141963 0
Email 141963 0
[email protected]
Contact person for scientific queries
Name 141964 0
Ralph Maddison
Address 141964 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 141964 0
Australia
Phone 141964 0
+61 392446218
Fax 141964 0
Email 141964 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.