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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12618001708246
Ethics application status
Approved
Date submitted
13/10/2018
Date registered
16/10/2018
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Date results information initially provided
28/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
General Practitioners screen their patients for irregular heart rhythms
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Scientific title
General Practitioners Screen their patients for Atrial Fibrillation and othEr aRrhythmias (GPSAFER)
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Secondary ID [1]
296317
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None
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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:
atrial fibrillation
310027
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arrhythmias
310028
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Condition category
Condition code
Cardiovascular
308780
308780
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0
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Other cardiovascular diseases
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Public Health
308808
308808
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0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This was a cross-sectional online survey aiming to recruit a diverse sample of GPs and GP registrars practising in urban and rural settings across Australia. The survey was distributed from 19th October 2018 to 31st March 2019 via GP networks and organisations.
The following topics were investigated in the survey: arrhythmia screening, awareness of the Australian AF Guidelines, use of conventional 12-lead ECG and handheld single-lead ECG devices, and practitioners’ confidence in ECG interpretation and need for training.
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Intervention code [1]
312646
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
307759
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The proportion of General Practitioners who performed any form of AF screening and identify the methods they applied
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Assessment method [1]
307759
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Timepoint [1]
307759
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The survey was open for 6 months and responses were collected using specifically designed questionnaire.
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Primary outcome [2]
307760
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General Practitioners’ awareness of the Australian Atrial Fibrillation Guidelines and approaches to arrhythmia screening
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Assessment method [2]
307760
0
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Timepoint [2]
307760
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The survey was open for 6 months and responses were collected using specifically designed questionnaire.
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Primary outcome [3]
307761
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The roles of conventional 12-lead ECG and mobile health devices
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Assessment method [3]
307761
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Timepoint [3]
307761
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The survey was open for 6 months and responses were collected using specifically designed questionnaire.
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Secondary outcome [1]
352805
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General Practitioners’ confidence in ECG interpretation and need for training.
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Assessment method [1]
352805
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Timepoint [1]
352805
0
The survey was open for 6 months and responses were collected using specifically designed questionnaire.
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Secondary outcome [2]
352806
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list of the General Practitioners' preferred mode of ECG interpretation training
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Assessment method [2]
352806
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Timepoint [2]
352806
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The survey was open for 6 months and responses were collected using specifically designed questionnaire.
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Eligibility
Key inclusion criteria
General Practitioners and General Practitioners Registrars who practise in Australia
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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?
Yes
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Key exclusion criteria
General Practitioners who are practising outside Australia
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Random sample
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Timing
Prospective
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Statistical methods / analysis
Sample Size Computation: Assuming a conservative estimation that 50% of GPs performed any form of AF screening, the study would require a sample size of 385 for estimating the expected proportion with 5% absolute precision and 95% confidence. That is, we would be 95% confident that between 45% and 55% of the GP population did some form of AF screening.
Statistical Analysis: Categorical variables were analysed using Chi-square or Fisher Exact Tests. 95% confidence intervals (CI) for proportions were computed. Statistical significance level was set at P-value <0.05. Analysis was performed using SPSS version 25.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
18/10/2018
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Actual
19/10/2018
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Date of last participant enrolment
Anticipated
16/08/2019
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Actual
31/03/2019
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Date of last data collection
Anticipated
18/10/2019
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Actual
31/03/2019
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Sample size
Target
385
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Accrual to date
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Final
463
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
300914
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University
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Name [1]
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Westmead Applied Research Centre, University of Sydney
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Address [1]
300914
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WARC, Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
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Country [1]
300914
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Australia
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Primary sponsor type
University
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Name
Westmead Applied Research Centre, University of Sydney
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Address
Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
300478
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None
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Name [1]
300478
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None
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Address [1]
300478
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Not applicable
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Country [1]
300478
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301682
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Human Research Ethics Committee, University of Sydney
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Ethics committee address [1]
301682
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Margaret Telfer Building (K07)
University of Sydney
NSW 2006
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Ethics committee country [1]
301682
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Australia
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Date submitted for ethics approval [1]
301682
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31/07/2018
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Approval date [1]
301682
0
09/10/2018
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Ethics approval number [1]
301682
0
2018/740
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Summary
Brief summary
Atrial fibrillation (AF) and other arrhythmias are common medical problems of increasing prevalence which are often identified and managed by General Practitioners (GPs). The aims of the survey and interview are to explore the views, knowledge and practices of GPs with respect to cardiac arrhythmias, and additionally to explore the role of mobile health devices in screening. The information is important to health policy makers, education providers and professional bodies.
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Trial website
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Trial related presentations / publications
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Public notes
This study is applicable to General Practitioners and General Practitioner Registrars who are practising in Australia.
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Attachments [1]
3163
3163
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0
/AnzctrAttachments/376179-Ethics Approval [2018_740] Application Outcome_Cat A.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
87774
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Prof Clara Chow
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Address
87774
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Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
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Country
87774
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Australia
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Phone
87774
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+61 2 8890 3125
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Fax
87774
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Email
87774
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[email protected]
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Contact person for public queries
Name
87775
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Prof Clara Chow
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Address
87775
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Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
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Country
87775
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Australia
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Phone
87775
0
+61 2 8890 3125
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Fax
87775
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Email
87775
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[email protected]
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Contact person for scientific queries
Name
87776
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Prof Clara Chow
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Address
87776
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Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
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Country
87776
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Australia
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Phone
87776
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+61 2 8890 3125
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Fax
87776
0
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Email
87776
0
[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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Wong, K.C., Kok, C., Marschner, S., Usherwood T., ...
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Documents added automatically
No additional documents have been identified.
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