None listed
Conditions
Brief summary
HF-REACH is a study evaluating whether a nurse-led digital heart failure program can help reduce worsening heart failure compared with usual care. People taking part will either receive support from the CardioNexus nursing team using a mobile app or continue with their usual care. The program includes daily monitoring, education, and support from experienced heart failure nurses. We believe that this approach will help identify changes in health earlier and reduce heart failure-related emergency department visits and hospital admissions. The study aims to improve access to high-quality heart failure care for people living in regional Australia.
Interventions
Recent heart failure hospitalisation (90 days): Participants will be stratified at randomisation according to whether they have experienced a heart failure-related hospitalisation within the 90 days preceding enrolment or more than 90 days prior to enrolment.
* Treating clinician training: Treating clinicians (GPs, cardiologists, and participating clinicians) will receive a 30-minute online onboarding session provided by the CardioNexus study team before the first participant is enrolled at thei
Recent heart failure hospitalisation (90 days): Participants will be stratified at randomisation according to whether they have experienced a heart failure-related hospitalisation within the 90 days preceding enrolment or more than 90 days prior to enrolment. * Treating clinician training: Treating clinicians (GPs, cardiologists, and participating clinicians) will receive a 30-minute online onboarding session provided by the CardioNexus study team before the first participant is enrolled at their site. The session will cover the study workflow, clinician responsibilities, communication pathways, and management of nurse-generated clinical alerts. Additional support will be available throughout the study as required. * Mobile application: The Heart Failure mobile application is an existing digital health platform used by CardioNexus for remote heart failure monitoring and has not been developed specifically for this study. * Heart failure education: Participants allocated to the intervention will receive a 60-minute individual telephone onboarding session with a CardioNexus heart failure nurse covering heart failure, symptom recognition, self-management, use of the mobile application, and when to seek medical care. * Medication adherence support: Nurses will review medication adherence during scheduled or clinically indicated telephone consultations and reinforce adherence to medications prescribed by the participant’s treating clinician. * Remote monitoring: Participants will record daily weight, blood pressure, heart rate, and heart failure symptoms using the mobile application for 6 months. Data are reviewed remotely by the CardioNexus nursing team on weekdays. * Protocol-driven escalation: Where monitoring identifies potential deterioration, the CardioNexus nurse will conduct a telephone clinical assessment (approximately 15 minutes) and, if required, notify the participant’s treating clinician in accordance with the study escalation protocol. Treating clinicians remain responsible for medical management and respond to alerts within their usual clinical workflow. * Welfare checks: If participant data are missing or participants become disengaged, the nursing team performs twice-weekly reviews of monitoring data. Participants who have not submitted data or cannot be contacted through routine monitoring will receive a welfare telephone call to confirm wellbeing, troubleshoot barriers to engagement, and encourage continued participation. This service is not an emergency service.
Sponsors
CardioNexus Remote Monitoring Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years 2. Established diagnosis of chronic HF (HFrEF or HFpEF) documented in the medical record, based on prior clinical assessment consistent with contemporary guidelines 3. Receiving community-based care for HF at the time of enrolment (i.e., not currently an inpatient) 4. Access to a mobile phone or internet-enabled device capable of supporting the mHealth platform (with assistance if required, or study device provided if necessary) 5. Able to provide informed consent in English 6. Willing to participate for the 6-month study duration
Exclusion criteria
Participants meeting ANY of the following criteria will be excluded: 1. Specialist HF Phenotypes: Participants with known or suspected specialist HF phenotypes requiring disease-specific management pathways, including: Cardiac amyloidosis Pulmonary arterial hypertension Congenital heart disease Hypertrophic cardiomyopathy Active myocarditis 2. Advanced HF: Currently listed for heart transplantation/ left ventricular assist device (LVAD) support 3. Planned Procedures: Planned cardiac surgery or advanced interventional procedures within the study's 6-month follow-up period 4. Severe Comorbidity: Life expectancy <6 months unrelated to HF (in the investigator's clinical judgment) 5. Cognitive and Communication Barriers: Cognitive impairment without a capable carer)/ Insufficient English language proficiency 6. Technology Barriers: No access to a smartphone or internet-enabled device 7. Mental Health: Severe mental illness that would prevent safe participation (e.g., active psychosis, severe untreated depression with suicidal ideation) 8. Other Clinical Trials: Enrolled in another interventional clinical trial with overlapping interventions (Participation in observational studies or non-overlapping intervention trials is permitted). 9. Residential Status: Residing in nursing home or residential aged care facility where daily monitoring would be impractical (Retirement villages and independent living facilities are NOT exclusions if participant manages their own care). 10. Geographic Instability: Planning to relocate outside Australia within the 6-month study period 11. Previous Participation: Previously enrolled in this study (participants cannot re-enrol) 12. Investigator Discretion: Any other condition or circumstance that, in the opinion of the investigator, would make participation unsafe or impractical
Outcome results
None listed