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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
16/10/2018
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
Survey and interview General Practitioners' views, knowledge and practices in screening for atrial fibrillation and other arrhythmias. Proposed duration of the study October 2018 to October 2019.
(1) The online self-administered survey will take approximately 5 minutes. The one-on-one interview will take approximately 20 to 30 minutes. The total length of exposure/ observation for each participant who takes part in both survey and interview will be approximately 25 to 35 minutes.
(2) With regards to the interview:
(a) It will take approximately 20 to 30 minutes
(b) It will occur approximately three to four months after launching of the online survey
(c) The researcher, Dr Kam Wong, will conduct the interview
(d) The purposes of the interview are to understand how the participants screen for arrhythmias, investigate the use of conventional 12-lead ECG and mobile health devices to perform the screening, and explore the barriers and enablers of performing screening and using the technology.
The content includes “screening for atrial fibrillation and other arrhythmias”, “use of a conventional 12-lead ECG in arrhythmia screening and the barriers & enablers”, and “awareness and use of mobile health devices and the barriers & enablers”.
Intervention code [1] 312646 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307759 0
Proportion of General Practitioners screen their asymptomatic patients for atrial fibrillation
Timepoint [1] 307759 0
Responses collected during one year cross-sectional study using specifically designed questionnaire and interview questions.
Primary outcome [2] 307760 0
Proportion of General Practitioners screen their asymptomatic patients for arrhythmias other than atrial fibrillation
Timepoint [2] 307760 0
Responses collected during one year cross-sectional study using specifically designed questionnaire and interview questions.
Primary outcome [3] 307761 0
Proportion of General Practitioners use mobile health devices to screen their patients for arrhythmias
Timepoint [3] 307761 0
Responses collected during one year cross-sectional study using specifically designed questionnaire and interview questions.
Secondary outcome [1] 352805 0
Proportion of General Practitioners wish to receive ECG interpretation training
Timepoint [1] 352805 0
Responses collected during one year cross-sectional study using specifically designed questionnaire and interview questions.
Secondary outcome [2] 352806 0
list of the General Practitioners' preferred mode of ECG interpretation training
Timepoint [2] 352806 0
Responses collected during one year cross-sectional study using specifically designed questionnaire and interview questions.

Eligibility
Key inclusion criteria
General Practitioners and General Practitioners Registrars who practise in Australia
Minimum age
18 Years
Maximum age
No limit
Gender
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
Sampling and sample size estimation:
Taking the 5% response rate of the RACGP's online survey on General Practitioners across Australia as reference, we aim to recruit 1800 GPs across Australia (5% of the current total 35934 GPs). In order to recruit a representative sample, the expected minimum number of participants for the online survey from each state/territory is set with reference to the Department of Health’s statistics on GP populations in 2016-17.

At the completion of the online survey using the University subscribed REDCap portal, the survey data will be downloaded to SPSS. Each participant will be deidentified using a serial number. We will compile a list of all participants who agree to being contacted
for an interview. Using the descriptive data collected in the survey, we will invite
a range of participants to represent a wide range of locations of practice, gender, roles
(GP/ GP registrars) and years of experience. We will follow an interview guide and
conduct one-to-one interview via Skype or telephone. The interviews will be recorded and transcribed for qualitative analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 300914 0
WARC, Research & Education Network
Westmead Hospital
NSW 2145 AUSTRALIA
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
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
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
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.
Trial website

Trial related presentations / publications
Public notes
This study is applicable to General Practitioners and General Practitioner Registrars who are practising in Australia.

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
Prof 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
Prof 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

No data has been provided for results reporting
Summary results
Not applicable