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Trial registered on ANZCTR
Registration number
ACTRN12624001242516
Ethics application status
Approved
Date submitted
25/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Practice Nurses to Augment the Clinical Evaluation and cAre of people at high-risk of Heart Failure (PANACEA-HF) Trial
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Scientific title
Practice Nurses to Augment the Clinical Evaluation and cAre of people at high-risk of Heart Failure (PANACEA-HF) Trial: A multicentre. pragmatic health care surveillance and nested intervention trial
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Secondary ID [1]
311925
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None
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Universal Trial Number (UTN)
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Trial acronym
PANACEA-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
heart failure
333511
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Condition category
Condition code
Cardiovascular
330192
330192
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0
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Other cardiovascular diseases
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Public Health
331929
331929
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Trial participants will be randomized (1:1 stratified for biological sex and study site) to:
1. An enhanced form of standard primary care, whereby the participant's usual GP will receive a report detailing the results of an artificial intelligence-guided portable echo, 12-lead ECG and clinical profiling, along with a 2-page summary of the current (European Society of Cardiology/Cardiac Society of Australia & New Zealand) recommendations for the treatment/management of adults with evidence of left ventricular dysfunction/clinical heart failure. Where appropriate, GPs will have access to a Cardiologist to seek advice on specific treatment goals.
2. In addition to the above, participants will be case-managed by primary health care nurse (PHCN) who will perform a home visit (taking 60-90 minutes to complete), assess their ongoing health care/personal needs using an established tool (the Green Amber Red Delineation of Need and Risk in HF - GARDIAN-HF) and provide individualized support for the 12 months following initial screening/group randomization. This will include specific plans to up-titrate any prescribed pharmacological therapy and application of non-pharmacological strategies to enhance health literacy (liaising with local pharmacists), self-care and overall heart health (e.g. exercise and dietary plans). Adherence to pharmacological treatment will be monitored via clinical response (e.g. lowered BP and lipid levels) along with documentation of all routine (e.g. attendance to scheduled GP visits) and additional (e.g. phone calls and home visits) health care contacts.
To deliver the intervention all PHCN will receive educational materials pertaining to cardiac imaging, cardiac anatomy and heart failure management in the 3 months prior to formal commencement of the project. In the month prior to this timepoint, they will also under a 2-day, face-to-face educational program on heart failure care (from a primary care perspective) by an expert in the field. All training/educational activities will be overseen by the Australian Primary Health Care Nurses Association.
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Intervention code [1]
329601
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Lifestyle
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Intervention code [2]
329655
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Behaviour
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Intervention code [3]
329656
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Early detection / Screening
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Comparator / control treatment
The control group will comprise those participants randomized to receive the enhanced form of primary health care only. Specifically -
An enhanced form of standard primary care, whereby the participant's usual GP will receive a report detailing the results of a portable echo, 12-lead ECG and clinical profiling, along with a 2-page summary of the current (ESC/CSANZ) recommendations for the treatment/management of adults with evidence of left ventricular dysfunction/clinical heart failure. Where appropriate, GPs will have access to a Cardiologist to seek advice on specific treatment goals.
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Control group
Active
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Outcomes
Primary outcome [1]
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Event-free free from the composite endpoint of all-cause hospitalization and all-cause death as measured by the fractional measure of Days-Alive and Out-Hospital (computed as the proportion of actual/maximal days post randomization to study census)
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Assessment method [1]
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Medical Records/Death Registry
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Timepoint [1]
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Minimum 2-year follow-up post randomization. This composite outcome will be monitored monthly via medical records and during phone follow-up of participants at 12- and 24-months post randomization.
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Secondary outcome [1]
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All-cause hospital stay
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Assessment method [1]
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Electronic medical records - calculated as the number of days of all-cause hospital per month of active follow-up.
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Timepoint [1]
440073
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Minimum 2-years follow-up post randomization. This outcome will be monitored monthly via medical records and during phone follow-up of participants at 12- and 24-months post randomization.
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Secondary outcome [2]
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All-cause mortality
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Assessment method [2]
440074
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Medical Records/Death Registry
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Timepoint [2]
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Minimum 2-years follow-up. This outcome will be monitored monthly via medical records and during phone follow-up of participants at 12- and 24-months post randomization.
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Secondary outcome [3]
440075
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Health-Related Quality of Life
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Assessment method [3]
440075
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AQ0L-8D
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Timepoint [3]
440075
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Assessed at 1- and 2-years post-randomization among survivors
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Secondary outcome [4]
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Depression & Anxiety - this will be assessed as a composite outcome.
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Assessment method [4]
440076
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Hospital Anxiety and Depression Scales
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Timepoint [4]
440076
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Assessed 1- and 2-years post randomization among survivors
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Secondary outcome [5]
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Health care costs
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Assessment method [5]
440077
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Nested health economic analysis of tertiary care, primary health care, treatment and out-of-pocket expenses. Health care costs will be determined from the medical records of participating GPs (Medicare reimbursement, MBS items and PBS items) and the DRGs/length of stay associated with hospital readmissions. Out-of-pocket expenses from GP visits and pharmacotherapy will be derived from medical records and self-report (including transport costs to attend health visits).
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Timepoint [5]
440077
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Minimum 2-years follow-up post randomization. This outcome will be monitored monthly via medical records and during phone follow-up of participants at 12- and 24-months post randomization.
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Eligibility
Key inclusion criteria
Eligible individuals being actively treated at participating GP clinics who:
1. Are aged 60 years.
2. Have the common antecedents of heart failure (any combination hypertension, diabetes and any form of cardiovascular disease) documented in their GP records.
3. On targeted echocardiographic screening have evidence of left ventricular dysfunction (systolic or diastolic) combined with an bio-marker evidence of elevated filling pressures (NT-proBNP) and/or symptoms indicative of cardiac congestion.
4. Live independently
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unable to provide informed consent
2. Terminal illness likely to result in death (as considered by the treating GP) within the next 12-24 months.
3. Pre-existing diagnosis (according to the GP records) of heart failure.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer maintained by an independent data management group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation stratified for study site and biological sex.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Estimated Study Power: When followed-up for a median of 2.5 years, the maximal number of event-free days for 100 people = 91,250 days alive-out-of-hospital (DAOH). Among the trial cohort, it is estimated that without any intervention 85.4% of actual/expected DAOH will be observed. Assuming a modest/feasible improvement in survival (absolute 5% reduction in mortality) and 20% reduction in hospital stay, a feasible, minimum target of 160 per group will provide >85% study power (2-sided alpha <0.05) to detect a 10% difference in DAOH between groups, whilst providing sufficient power to detect significant difference in secondary outcomes of interest.
Statistical Analyses: A pre-specified Statistical Analysis Plan will be applied by the (independent) Trial Statistician (blinded to group assignment) testing the study hypothesis (null form) on an intention-to-treat basis. DAOH, hospital stay/event rates and other continuous data (e.g., change in QoL scores) will be analyzed with Student’s t Test, Mann-Whitney U test or negative binomial regression and log gamma regression. The number of excess events (admission/death) will be examined via fixed-effect models and ordinary least squares.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
30/11/2027
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Actual
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Sample size
Target
320
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Funding & Sponsors
Funding source category [1]
316270
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Government body
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Name [1]
316270
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Department of Health and Aged Care Medical Research Future Fund of Australia - Primary Health Care Research Initiative (MRF2031996)
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Address [1]
316270
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Country [1]
316270
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Australia
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Primary sponsor type
University
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Name
University of Notre Dame Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
319781
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None
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Name [1]
319781
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Address [1]
319781
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Country [1]
319781
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Other collaborator category [1]
283233
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Commercial sector/Industry
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Name [1]
283233
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Australian Primary Health Care Nurses Association
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Address [1]
283233
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Country [1]
283233
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Australia
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Other collaborator category [2]
283234
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University
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Name [2]
283234
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Torrens University Australia
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Address [2]
283234
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Country [2]
283234
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Australia
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Other collaborator category [3]
283235
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University
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Name [3]
283235
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Griffith University
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Address [3]
283235
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Country [3]
283235
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Australia
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Other collaborator category [4]
283236
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University
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Name [4]
283236
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University of Glasgow
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Address [4]
283236
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Country [4]
283236
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United Kingdom
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Other collaborator category [5]
283237
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Other
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Name [5]
283237
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Whites Road Medical Centre
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Address [5]
283237
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Country [5]
283237
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Australia
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Other collaborator category [6]
283238
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Other
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Name [6]
283238
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Horsham Medical Centre
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Address [6]
283238
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Country [6]
283238
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Australia
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Other collaborator category [7]
283239
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Other
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Name [7]
283239
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Springs Medical Centre
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Address [7]
283239
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Country [7]
283239
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315090
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The University of Notre Dame Australia Human Research Ethics Committee
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Ethics committee address [1]
315090
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https://www.notredame.edu.au/research/research-at-notre-dame/ethics-and-integrity/hre/hrec
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Ethics committee country [1]
315090
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Australia
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Date submitted for ethics approval [1]
315090
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17/04/2024
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Approval date [1]
315090
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27/05/2024
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Ethics approval number [1]
315090
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2024 - 051
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Summary
Brief summary
When left undiagnosed and untreated, Heart Failure (HF) is a complex, chronic condition associated with poor quality of life, recurrent hospital admissions and premature mortality. Consistent with a recent Strengthening Medicare Taskforce Report, this project is applying the latest point-of-care technology (including an Artificial-Intelligence guided cardiac imaging) to enhance the pivotal role of Primary Health Care Nurses (PHCNs) to cost-effectively detect and then care for people with HF in primary care. In a two-phased approach, >1000 at risk people across 3 urban, regional and rural communities, will be screened for previously undetected HF. Those found to have HF, will then be invited to participate in a trial of standard GP care versus a Practice Nurse-coordinated, multidisciplinary, primary care surveillance and intervention program. We hypothesize that those people assigned to the Practice Nurse coordinated care program will experience better health outcomes than those assigned to receive standard GP care. During minimum two-years follow-up we will compare the health outcomes (including need for hospital care and quality of life) of those exposed to standard care versus the Practice Nurse-led care program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Simon Stewart
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Address
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Institute for Health Research, University of Notre Dame Australia (Fremantle Campus), 21 Henry St Fremantle, WA 6160.
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Country
133642
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Australia
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Phone
133642
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+61 404285222
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Fax
133642
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Email
133642
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[email protected]
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Contact person for public queries
Name
133643
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Simon Stewart
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Address
133643
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Institute for Health Research, University of Notre Dame Australia (Fremantle Campus), 21 Henry St Fremantle, WA 6160.
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Country
133643
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Australia
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Phone
133643
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+61 404285222
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Fax
133643
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Email
133643
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[email protected]
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Contact person for scientific queries
Name
133644
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Simon Stewart
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Address
133644
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Institute for Health Research, University of Notre Dame Australia (Fremantle Campus), 21 Henry St Fremantle, WA 6160.
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Country
133644
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Australia
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Phone
133644
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+61 404285222
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Fax
133644
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Email
133644
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Abbreviated, de-identified (including concealment of study site) profiling and outcome data.
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When will data be available (start and end dates)?
From mid-2028 (depending on master database lock date and subsequent reporting) for a period of 5 years.
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Available to whom?
All researchers who submit a formal, scientifically based request to the Principal Investigator/Executive Investigators with evidence of ethics approval to seek and then analyze data. Decisions to share data will be determined on a case-by-case basis.
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Available for what types of analyses?
Systematic reviews, meta-analyses and comparator studies
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How or where can data be obtained?
Email to the Principal Investigator - Professor Simon Stewart, Institute for Health Research, University of Notre Dame Australia (
[email protected]
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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.
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