Trial Review

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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 provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
General Practitioners screen their patients for irregular heart rhythms
Scientific title
General Practitioners Screen their patients for Atrial Fibrillation and othEr aRrhythmias (GPSAFER)
Secondary ID [1] 296317 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 310027 0
arrhythmias 310028 0
Condition category
Condition code
Cardiovascular 308780 308780 0 0
Other cardiovascular diseases
Public Health 308808 308808 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 312646 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307759 0
The proportion of General Practitioners who performed any form of AF screening and identify the methods they applied
Timepoint [1] 307759 0
The survey was open for 6 months and responses were collected using specifically designed questionnaire.
Primary outcome [2] 307760 0
General Practitioners’ awareness of the Australian Atrial Fibrillation Guidelines and approaches to arrhythmia screening
Timepoint [2] 307760 0
The survey was open for 6 months and responses were collected using specifically designed questionnaire.
Primary outcome [3] 307761 0
The roles of conventional 12-lead ECG and mobile health devices
Timepoint [3] 307761 0
The survey was open for 6 months and responses were collected using specifically designed questionnaire.
Secondary outcome [1] 352805 0
General Practitioners’ confidence in ECG interpretation and need for training.
Timepoint [1] 352805 0
The survey was open for 6 months and responses were collected using specifically designed questionnaire.
Secondary outcome [2] 352806 0
list of the General Practitioners' preferred mode of ECG interpretation training
Timepoint [2] 352806 0
The survey was open for 6 months and responses were collected using specifically designed questionnaire.

Eligibility
Key inclusion criteria
General Practitioners and General Practitioners Registrars who practise in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Practitioners who are practising outside Australia

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2018
Actual
19/10/2018
Date of last participant enrolment
Anticipated
16/08/2019
Actual
31/03/2019
Date of last data collection
Anticipated
18/10/2019
Actual
31/03/2019
Sample size
Target
385
Accrual to date
Final
463
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300914 0
University
Name [1] 300914 0
Westmead Applied Research Centre, University of Sydney
Country [1] 300914 0
Australia
Primary sponsor type
University
Name
Westmead Applied Research Centre, University of Sydney
Address
Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 300478 0
None
Name [1] 300478 0
None
Address [1] 300478 0
Not applicable
Country [1] 300478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301682 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 301682 0
Ethics committee country [1] 301682 0
Australia
Date submitted for ethics approval [1] 301682 0
31/07/2018
Approval date [1] 301682 0
09/10/2018
Ethics approval number [1] 301682 0
2018/740

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3163 3163 0 0
/AnzctrAttachments/376179-Ethics Approval [2018_740] Application Outcome_Cat A.pdf (Ethics approval)

Contacts
Principal investigator
Name 87774 0
Prof Clara Chow
Address 87774 0
Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
Country 87774 0
Australia
Phone 87774 0
+61 2 8890 3125
Fax 87774 0
Email 87774 0
clara.chow@sydney.edu.au
Contact person for public queries
Name 87775 0
Clara Chow
Address 87775 0
Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
Country 87775 0
Australia
Phone 87775 0
+61 2 8890 3125
Fax 87775 0
Email 87775 0
clara.chow@sydney.edu.au
Contact person for scientific queries
Name 87776 0
Clara Chow
Address 87776 0
Westmead Applied Research Centre
The University of Sydney
Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
Country 87776 0
Australia
Phone 87776 0
+61 2 8890 3125
Fax 87776 0
Email 87776 0
clara.chow@sydney.edu.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.