Trial Review

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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
Scientific title
Effect of a patient centered toolkit as part of the discharge process on re-presentations following admission for heart attack.
Secondary ID [1] 312439 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myocardial infarction 334265 0
Hospital readmissions 334266 0
Condition category
Condition code
Cardiovascular 330925 330925 0 0
Coronary heart disease
Public Health 330926 330926 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328945 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 338690 0
Re-presentation to hospital
Timepoint [1] 338690 0
30 days post discharge
Secondary outcome [1] 437036 0
Wellbeing and satisfaction with their treatment will be measured as a composite secondary outcome.
Timepoint [1] 437036 0
7 days post-discharge
Secondary outcome [2] 437037 0
Angina
Timepoint [2] 437037 0
Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
Secondary outcome [3] 437038 0
Quality of life
Timepoint [3] 437038 0
Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
Secondary outcome [4] 437039 0
Anxiety
Timepoint [4] 437039 0
Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.
Secondary outcome [5] 437040 0
Depression
Timepoint [5] 437040 0
Baseline (during the index hospitalisation for acute myocardial infarction) and 30 days post-discharge.

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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
n = 236 per group

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
472
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26748 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 26749 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 42796 0
5000 - Adelaide
Recruitment postcode(s) [2] 42797 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 316857 0
Charities/Societies/Foundations
Name [1] 316857 0
Royal Adelaide Hospital (RAH) Research Fund
Country [1] 316857 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 319094 0
Hospital
Name [1] 319094 0
Royal Adelaide Hospital
Address [1] 319094 0
Country [1] 319094 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315616 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315616 0
Ethics committee country [1] 315616 0
Australia
Date submitted for ethics approval [1] 315616 0
28/03/2024
Approval date [1] 315616 0
02/04/2024
Ethics approval number [1] 315616 0

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

Contacts
Principal investigator
Name 135266 0
Dr Clementine Labrosciano
Address 135266 0
The Queen Elizabeth Hosptial, Level 5B, 28 Woodville Rd, Woodville, South Australia, 5011
Country 135266 0
Australia
Phone 135266 0
+61 08 8222 7413
Fax 135266 0
Email 135266 0
clementine.labrosciano@sa.gov.au
Contact person for public queries
Name 135267 0
Clementine Labrosciano
Address 135267 0
The Queen Elizabeth Hosptial, Level 5B, 28 Woodville Rd, Woodville, South Australia, 5011
Country 135267 0
Australia
Phone 135267 0
+61 08 8222 7413
Fax 135267 0
Email 135267 0
clementine.labrosciano@sa.gov.au
Contact person for scientific queries
Name 135268 0
Clementine Labrosciano
Address 135268 0
The Queen Elizabeth Hosptial, Level 5B, 28 Woodville Rd, Woodville, South Australia, 5011
Country 135268 0
Australia
Phone 135268 0
+61 08 8222 7413
Fax 135268 0
Email 135268 0
clementine.labrosciano@sa.gov.au

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.