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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
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
Secondary ID [1] 311925 0
None
Universal Trial Number (UTN)
Trial acronym
PANACEA-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 333511 0
Condition category
Condition code
Cardiovascular 330192 330192 0 0
Other cardiovascular diseases
Public Health 331929 331929 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329601 0
Lifestyle
Intervention code [2] 329655 0
Behaviour
Intervention code [3] 329656 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 339464 0
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)
Timepoint [1] 339464 0
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.
Secondary outcome [1] 440073 0
All-cause hospital stay
Timepoint [1] 440073 0
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.
Secondary outcome [2] 440074 0
All-cause mortality
Timepoint [2] 440074 0
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.
Secondary outcome [3] 440075 0
Health-Related Quality of Life
Timepoint [3] 440075 0
Assessed at 1- and 2-years post-randomization among survivors
Secondary outcome [4] 440076 0
Depression & Anxiety - this will be assessed as a composite outcome.
Timepoint [4] 440076 0
Assessed 1- and 2-years post randomization among survivors
Secondary outcome [5] 440077 0
Health care costs
Timepoint [5] 440077 0
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.

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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 randomization by computer maintained by an independent data management group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation stratified for study site and biological sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 316270 0
Government body
Name [1] 316270 0
Department of Health and Aged Care Medical Research Future Fund of Australia - Primary Health Care Research Initiative (MRF2031996)
Country [1] 316270 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
Country
Australia
Secondary sponsor category [1] 319781 0
None
Name [1] 319781 0
Address [1] 319781 0
Country [1] 319781 0
Other collaborator category [1] 283233 0
Commercial sector/Industry
Name [1] 283233 0
Australian Primary Health Care Nurses Association
Address [1] 283233 0
Country [1] 283233 0
Australia
Other collaborator category [2] 283234 0
University
Name [2] 283234 0
Torrens University Australia
Address [2] 283234 0
Country [2] 283234 0
Australia
Other collaborator category [3] 283235 0
University
Name [3] 283235 0
Griffith University
Address [3] 283235 0
Country [3] 283235 0
Australia
Other collaborator category [4] 283236 0
University
Name [4] 283236 0
University of Glasgow
Address [4] 283236 0
Country [4] 283236 0
United Kingdom
Other collaborator category [5] 283237 0
Other
Name [5] 283237 0
Whites Road Medical Centre
Address [5] 283237 0
Country [5] 283237 0
Australia
Other collaborator category [6] 283238 0
Other
Name [6] 283238 0
Horsham Medical Centre
Address [6] 283238 0
Country [6] 283238 0
Australia
Other collaborator category [7] 283239 0
Other
Name [7] 283239 0
Springs Medical Centre
Address [7] 283239 0
Country [7] 283239 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315090 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 315090 0
Ethics committee country [1] 315090 0
Australia
Date submitted for ethics approval [1] 315090 0
17/04/2024
Approval date [1] 315090 0
27/05/2024
Ethics approval number [1] 315090 0
2024 - 051

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

Contacts
Principal investigator
Name 133642 0
Prof Simon Stewart
Address 133642 0
Institute for Health Research, University of Notre Dame Australia (Fremantle Campus), 21 Henry St Fremantle, WA 6160.
Country 133642 0
Australia
Phone 133642 0
+61 404285222
Fax 133642 0
Email 133642 0
simon.stewart@nd.edu.au
Contact person for public queries
Name 133643 0
Simon Stewart
Address 133643 0
Institute for Health Research, University of Notre Dame Australia (Fremantle Campus), 21 Henry St Fremantle, WA 6160.
Country 133643 0
Australia
Phone 133643 0
+61 404285222
Fax 133643 0
Email 133643 0
simon.stewart64@gmail.com
Contact person for scientific queries
Name 133644 0
Simon Stewart
Address 133644 0
Institute for Health Research, University of Notre Dame Australia (Fremantle Campus), 21 Henry St Fremantle, WA 6160.
Country 133644 0
Australia
Phone 133644 0
+61 404285222
Fax 133644 0
Email 133644 0
simon.stewart64@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Abbreviated, de-identified (including concealment of study site) profiling and outcome data.
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.
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.
Available for what types of analyses?
Systematic reviews, meta-analyses and comparator studies
How or where can data be obtained?
Email to the Principal Investigator - Professor Simon Stewart, Institute for Health Research, University of Notre Dame Australia (simon.stewart@nd.edu.au)


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.