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Trial registered on ANZCTR


Registration number
ACTRN12623001142628
Ethics application status
Approved
Date submitted
19/09/2023
Date registered
6/11/2023
Date last updated
6/11/2023
Date data sharing statement initially provided
6/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A risk-guided strategy for Acute Decompensated Heart Failure using mHealth.
Scientific title
SMART-Risk: effect of a risk-guided strategy on readmission and quality of life for Acute Decompensated Heart Failure using mHealth.
Secondary ID [1] 310574 0
TTRARP2109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 331431 0
Condition category
Condition code
Cardiovascular 328176 328176 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a two parallel-arm, type 2 hybrid randomised controlled trial to evaluate the impact of Smart-HF on quality of life and other secondary outcomes including reducing readmission to hospital. Enrolled patients classified with a high risk of hospital readmission and/or death - i.e., equal to or greater than the median of predicted risk, 33% based on the TAS-Help study algorithm developed by CIs Marwick and Huynh - will be randomised to either usual care or Smart-HF plus usual care, with stratification by study site and type of HF (reduced or preserved ejection fraction).
The intervention arm (SMART-HF) will involve the application of the Smart-HF app. Smart-HF provides patients a home-based heart failure care program which is linked to a clinician portal for creation of care plans and surveillance. The clinician-created care plan will identify goals for behaviour change such as increasing physical activity, as well as observations of symptoms of heart failure, such as rapid weight gain. Symptom observations are to be input into the Smart-HF app daily and based on this intensified home surveillance, the site co-ordinator (Heart Failure nurse) may arrange review of the patient at the rapid access clinic. Other patient reported outcome measures, including the Kansas City Cardiomyopathy Questionnaire are required at 30- and 90-days and 12 months. Smart HF also includes access to educational content on heart failure (self-)management. The linked clinician portal will be used to assess or monitor adherence or fidelity to the intervention.
The Smart-HF software, supported by smartphones or tablets, IOS and android software, delivers educational information, goal-settings, homework tasks, self-monitoring and questionnaires for heart failure, to allow patient progress and outcomes to be measured. Primary endpoint is quality of life at 30 days. Secondary outcomes include hospital readmission at 30 and 90 days post hospital discharge and 90-day composite outcome of days alive and out of hospital.
Intervention code [1] 326980 0
Treatment: Devices
Intervention code [2] 326981 0
Rehabilitation
Intervention code [3] 326982 0
Behaviour
Comparator / control treatment
Usual care defined as the routine care received by patients for the treatment of heart failure. In this instance, routine care consists of a multidisciplinary heart failure disease management program that comprises either home visits and/or telemonitoring or telephone support to support the patient during their transition from discharge from hospital back into the community.
Control group
Active

Outcomes
Primary outcome [1] 336122 0
Quality of life specific to heart failure symptoms assessed via the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Timepoint [1] 336122 0
Baseline, 30 days, 90 days (primary endpoint) and 12 months post study commencement.
Secondary outcome [1] 426910 0
Knowledge for heart failure assessed via European Heart Failure Self-Care Behavior Scale -9.
Timepoint [1] 426910 0
Baseline, 30 days, 90 days and 12 months post study commencement.
Secondary outcome [2] 426911 0
Cleland’s patient journey will be used to calculate - a refinement of days being at the hospital - days alive post discharge, out of hospital that is a composite endpoint of mortality, hospitalisation and well-being.
Timepoint [2] 426911 0
Baseline, 30 days, 90 days and 12 months post study commencement.
Secondary outcome [3] 428149 0
Hospital readmission assessed from patient self report and/or medical records
Timepoint [3] 428149 0
Hospital readmission at 30 and 90 days post discharge

Eligibility
Key inclusion criteria
Be eligible for Medicare
Emergency Department admission with a primary diagnosis of Acute Decompensated Heart Failure confirmed by the treating physicians, in accordance with the HF guidelines.
TasHelp risk score >33
Ownership or use of a smartphone or tablet device able to meet Cardihab app requirements (Android OS 9 or later / Apple iPhone or iPad iOS 13 or later).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide written informed consent to participate in this study.
Low e-health literacy score (eHEALS <26) or lack of access to a smartphone/tablet or wi-fi network
Patients that need palliative care.
Participating in another clinical research trial where randomisation to study arms would be unacceptable.
Patients who live in an aged care facility (e.g., Nursing Home)
Moderate to severe primary mitral or aortic valve disease
Concomitant unstable angina, acute myocardial infarction
Cardiac device malfunction
Endocarditis
Patients with Left Ventricular Assistant Device (LVAD)
Patients with asymptomatic Left Ventricular (LV) dysfunction
Potentially reversible LV dysfunction, such as post-partum, alcoholic cardiomyopathy, hyperthyroidism.
Abuse of alcohol or drugs
Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy)
Inability to acquire interpretable images (identified from baseline echo)
In the investigators opinion any other condition that may affect the safety procedures of the study. (Patient and personnel)

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Efficacy
Statistical methods / analysis
The statistics analyses will be performed using standard software STATA 15 (Statacorp, College Station, Texas, USA). Analysis will be based upon intention to treat. Quality of life using the KCCQ will be compared with a t-test and Mann-Whitney test. Quality of life measures over time will be analysed using the Generalised Estimating Equations (GEE) approach. Survival analysis will be used to compare admissions and other events over 30 days. The 30-day readmission rates in each arm will be compared using a chi square test, The effect size of the guided-DMP arm will be investigated using a logistic, linear and Cox models for readmissions, QOL and survival, respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2023
Actual
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 25558 0
Western Hospital - Footscray - Footscray
Recruitment hospital [2] 25559 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 25560 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 25561 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 41379 0
3011 - Footscray
Recruitment postcode(s) [2] 41380 0
3021 - St Albans
Recruitment postcode(s) [3] 41381 0
7000 - Hobart
Recruitment postcode(s) [4] 41382 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 314783 0
Government body
Name [1] 314783 0
MTPConnect
Country [1] 314783 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne, Victoria 3004,
Country
Australia
Secondary sponsor category [1] 316849 0
None
Name [1] 316849 0
Address [1] 316849 0
Country [1] 316849 0
Other collaborator category [1] 282816 0
Commercial sector/Industry
Name [1] 282816 0
Cardihab Pty Ltd
Address [1] 282816 0
3/315 Brunswick St, Fortitude Valley QLD 4006
Country [1] 282816 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313795 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 313795 0
Ethics committee country [1] 313795 0
Australia
Date submitted for ethics approval [1] 313795 0
23/03/2023
Approval date [1] 313795 0
29/03/2023
Ethics approval number [1] 313795 0
94405 (Local Reference: Project 101/23)

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

Contacts
Principal investigator
Name 129366 0
Prof Tom Marwick
Address 129366 0
Baker Heart and Diabetes Institute 75 Commercial Road, Melbourne, Victoria 3004,
Country 129366 0
Australia
Phone 129366 0
+61 3 8532 1550
Fax 129366 0
Email 129366 0
[email protected]
Contact person for public queries
Name 129367 0
Tom Marwick
Address 129367 0
Baker Heart and Diabetes Institute 75 Commercial Road, Melbourne, Victoria 3004,
Country 129367 0
Australia
Phone 129367 0
+61 3 8532 1550
Fax 129367 0
Email 129367 0
[email protected]
Contact person for scientific queries
Name 129368 0
Tom Marwick
Address 129368 0
Baker Heart and Diabetes Institute 75 Commercial Road, Melbourne, Victoria 3004,
Country 129368 0
Australia
Phone 129368 0
+61 3 8532 1550
Fax 129368 0
Email 129368 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?

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.