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Trial registered on ANZCTR
Registration number
ACTRN12624000870550
Ethics application status
Approved
Date submitted
2/07/2024
Date registered
16/07/2024
Date last updated
16/07/2024
Date data sharing statement initially provided
16/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Heart Attack Re-presentations Toolkit
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Scientific title
Effect of a patient centered toolkit as part of the discharge process on re-presentations following admission for heart attack.
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Secondary ID [1]
312439
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute myocardial infarction
334265
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Hospital readmissions
334266
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Condition category
Condition code
Cardiovascular
330925
330925
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0
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Coronary heart disease
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Public Health
330926
330926
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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
The participant will be contacted by a member of the research team at 7 days post discharge to ask about their transition back to the community. The participant will be contacted via phone and it is anticipated that it will take approximately 10 minutes. Participants will also be provided with an email option for the intervention, if they prefer. These questions will ask about hospital admission, satisfaction with hospital services and discharge planning. The participant will also be asked if they require any additional supports, and will be assisted by connecting them with the appropriate resources. Examples of support or resources that may be provided to participants include information about where to seek support for smoking cessation, 24/7 pharmacies to purchase prescribed medications and mental health support hotlines. Adherence to the intervention will be measured at the 30 day follow up by research staff.
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Intervention code [1]
328945
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Diagnosis / Prognosis
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Comparator / control treatment
Usual care with no phone call at 7 days. For the purposes of this study, usual care is defined as the treatment provided to the patient by the cardiology team in hospital, which adheres to the cardiology guidelines.
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Control group
Active
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Outcomes
Primary outcome [1]
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Re-presentation to hospital
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Assessment method [1]
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Electronic medical records and the patient will be asked at the 30 day outcome which is conducted either via phone call or email, depending on the participants preference.
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Timepoint [1]
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30 days post discharge
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Secondary outcome [1]
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Wellbeing and satisfaction with their treatment will be measured as a composite secondary outcome.
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Assessment method [1]
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The participant will be asked direct questions that will be assessed using a likert scale.
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Timepoint [1]
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7 days post-discharge
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Secondary outcome [2]
437037
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Angina
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Assessment method [2]
437037
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Seattle Angina Questionnaire
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Timepoint [2]
437037
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Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
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Secondary outcome [3]
437038
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Quality of life
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Assessment method [3]
437038
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EQ-5D-3L questionnaire
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Timepoint [3]
437038
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Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
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Secondary outcome [4]
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Anxiety
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Assessment method [4]
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Generalised Anxiety Disorder-7 (GAD-7)
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Timepoint [4]
437039
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Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
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Secondary outcome [5]
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Depression
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Assessment method [5]
437040
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Patient Health Questionnaire-8 (PHQ-8)
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Timepoint [5]
437040
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Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
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Eligibility
Key inclusion criteria
Presentation to The Queen Elizabeth Hospital or the Royal Adelaide Hospital with a diagnosis of Acute Myocardial Infarction (AMI) and aged over 18 years.
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Minimum age
18
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
No access to email or phone.
Immediate life-threatening illness or existing palliative care client.
Impaired cognitive state or communication barrier impacting on ability to self-manage that is irreconcilable by a carer.
Requires high level of residential care.
Potential participant not willing to participate.
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Study design
Purpose of the study
Educational / counselling / training
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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)
Randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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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
n = 236 per group
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/07/2024
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Date of last participant enrolment
Anticipated
30/04/2026
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Actual
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Date of last data collection
Anticipated
30/05/2026
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Actual
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Sample size
Target
472
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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The Queen Elizabeth Hospital - Woodville
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Recruitment postcode(s) [1]
42796
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5000 - Adelaide
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Recruitment postcode(s) [2]
42797
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5011 - Woodville
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
316857
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Royal Adelaide Hospital (RAH) Research Fund
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Address [1]
316857
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Country [1]
316857
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Australia
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Primary sponsor type
Government body
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Name
Central Adelaide Local Health Network
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Address
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Country
Australia
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Secondary sponsor category [1]
319094
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Hospital
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Name [1]
319094
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Royal Adelaide Hospital
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Address [1]
319094
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Country [1]
319094
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315616
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
315616
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315616
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Australia
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Date submitted for ethics approval [1]
315616
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28/03/2024
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Approval date [1]
315616
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02/04/2024
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Ethics approval number [1]
315616
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Summary
Brief summary
This study aims to reduce the re-presentation rate by better supporting patients with their transition back to the community after being discharged from hospital with an AMI through the implementation of a personalised discharge toolkit.
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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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Dr Clementine Labrosciano
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Address
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The Queen Elizabeth Hosptial, Level 5B, 28 Woodville Rd, Woodville, South Australia, 5011
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Country
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Australia
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Phone
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+61 08 8222 7413
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Fax
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Email
135266
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[email protected]
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Contact person for public queries
Name
135267
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Clementine Labrosciano
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Address
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The Queen Elizabeth Hosptial, Level 5B, 28 Woodville Rd, Woodville, South Australia, 5011
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Country
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Australia
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Phone
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+61 08 8222 7413
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Fax
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Email
135267
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[email protected]
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Contact person for scientific queries
Name
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Clementine Labrosciano
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Address
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The Queen Elizabeth Hosptial, Level 5B, 28 Woodville Rd, Woodville, South Australia, 5011
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Country
135268
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Australia
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Phone
135268
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+61 08 8222 7413
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Fax
135268
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Email
135268
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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)?
No
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No/undecided IPD sharing reason/comment
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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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