Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000013763
Ethics application status
Not required
Date submitted
25/11/2021
Date registered
11/01/2022
Date last updated
11/01/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Frailty in hospitalised heart failure patients and the effects of heart failure specific pharmacotherapy in frail heart failure patients
Scientific title
Prevalence of frailty in hospialised patients and the effects of heart failure specific pharamacotherapy in frail heart failure patients: an observational study
Secondary ID [1] 305892 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 324447 0
frailty 324448 0
hospitalised patients 324449 0
Condition category
Condition code
Cardiovascular 321936 321936 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- This study involves determination of frailty status of hospitalised heart failure patients by use of the Hospital Frailty Risk Score (HFRS)
- This study will include all data collected for all heart failure patients admitted between 2013-2020 from the electronic medical records
Intervention code [1] 322285 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator for this study will be those patients who did not receive heart failure specific pharmacotherapy.
Control group
Active

Outcomes
Primary outcome [1] 329690 0
To determine the prevalence of frailty as defined by the Hospital Frailty Risk Score (HFRS) in patients hospitalised with heart failure.
Timepoint [1] 329690 0
At the time of hospitalisation
Primary outcome [2] 329691 0
To determine any differences in the days alive and out of hospital (DAOH) in frail heart failure patients who received heart failure specific pharmacotherapy when compared to those who did not recieve treatment by data-linkage to medical records of participants.
Timepoint [2] 329691 0
At 90 days following discharge from hospital
Secondary outcome [1] 403457 0
To determine any difference in mortality at 30-days following discharge among frail heart failure patients who received heart failure specific pharmacotherapy compared to those who did not receive treatment
Timepoint [1] 403457 0
At 30-days following discharge from hospital.
Secondary outcome [2] 403458 0
To determine any differences in 30-day readmissions between frail hospitalised heart failure patients who received heart failure specific pharmacotherapy by data linkage to medical records of participants.
Timepoint [2] 403458 0
At 30-days following discharge from hospital

Eligibility
Key inclusion criteria
All patients 18 years or over who were admitted with a diagnosis of heart failure and admitted between 1 January 2013 to 31 December 2020 at Flinders Medical Centre (FMC) and Royal Adelaide Hospital (RAH), Adelaide, South Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The sample size for this study was based on a recent heart failure audit in FMC which included 109 heart failure patients and found that 30 day unplanned readmissions under General Medicine was 27% compared to 21% under cardiology service, with an alpha level of 0.05 and power of 90% a total sample size of 2126 will be sufficient for this study.
We will use propensity score matching to compare clinical outcomes in frail patients depending upon the receipt of heart failure specific pharmacotherapy.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2020
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
2126
Accrual to date
Final
2126
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21214 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 21215 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 36081 0
5042 - Bedford Park
Recruitment postcode(s) [2] 36082 0
5000 - Adelaide
Recruitment postcode(s) [3] 36083 0
5042 - Flinders University
Recruitment postcode(s) [4] 36084 0
5000 - Adelaide Bc

Funding & Sponsors
Funding source category [1] 310241 0
Hospital
Name [1] 310241 0
Flinders Medical Centre
Country [1] 310241 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 311342 0
None
Name [1] 311342 0
Address [1] 311342 0
Country [1] 311342 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 309920 0
Southern Adelaide Human Research Ethics Committee
Ethics committee address [1] 309920 0
Ethics committee country [1] 309920 0
Australia
Date submitted for ethics approval [1] 309920 0
Approval date [1] 309920 0
Ethics approval number [1] 309920 0

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

Contacts
Principal investigator
Name 115838 0
A/Prof Yogesh Sharma
Address 115838 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5052
Country 115838 0
Australia
Phone 115838 0
+61 882046694
Fax 115838 0
Email 115838 0
[email protected]
Contact person for public queries
Name 115839 0
Yogesh Sharma
Address 115839 0
Flinders Medical Centre
Flinders Drive
Flinders Drive
Bedford Park
South Australia 5042
Country 115839 0
Australia
Phone 115839 0
+61 882046694
Fax 115839 0
Email 115839 0
[email protected]
Contact person for scientific queries
Name 115840 0
Yogesh Sharma
Address 115840 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 115840 0
Australia
Phone 115840 0
+61 882046694
Fax 115840 0
Email 115840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data can be shared subject to approval by the ethics committee.
When will data be available (start and end dates)?
Immediately following publication for 5 years.
Available to whom?
Researchers who provide methodological sound proposal
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
Access subject to approval by Principal Investigator email:[email protected]


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
SourceTitleYear of PublicationDOI
EmbaseExternal Validation of the Hospital Frailty-Risk Score in Predicting Clinical Outcomes in Older Heart-Failure Patients in Australia.2022https://dx.doi.org/10.3390/jcm11082193
N.B. These documents automatically identified may not have been verified by the study sponsor.