Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000300279
Ethics application status
Approved
Date submitted
20/02/2018
Date registered
28/02/2018
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
"What’s your beat?": Reducing stroke risk through enhanced public awareness and screening for atrial fibrillation (AF)
Scientific title
"What’s your beat?": Reducing stroke risk through enhanced public awareness and screening for AF
Secondary ID [1] 294152 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 306711 0
Condition category
Condition code
Cardiovascular 305813 305813 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Public screening of atrial fibrillation (AF) in older individuals (aged 65 years or older, without known AF).
Internationally, there have been recent recommendations for more widespread screening for AF in those aged 65 years or older, as a cost-effective strategy for stroke prevention. This project will raise public awareness of AF and improve its detection, and hopefully lessen the burden of stroke in Tasmania. We intend to screen approximately 3,000 Tasmanians aged 65 years or older, and without previously diagnosed AF. Screening will take place throughout most of 2018 at a range of community venues across Tasmania.
People eligible for screening (aged 65 years or older, without known AF) will be provided with written information about the project, and informed consent will be obtained prior to conducting the screening assessment. A brief medical history will be taken (i.e. any symptoms, current medical conditions and medications). Individuals with an existing cardiac arrhythmia/pacemaker will be excluded.
Screening sessions will take place on approximately 100 occasions throughout most of 2018 at a range of community and organisation venues across Tasmania – including major shopping centres and Bunnings Warehouses (a partner of the Stroke Foundation), as well as at events such as Agfest. Educational talks on AF will accompany many of these events. The peak screening periods will be during August-October, and will include Stroke Week, along with Seniors Week in October. The second Atrial Fibrillation Awareness Week occurs in July, providing another opportunity to promote the project. Availability of screening will be communicated via the partner organisations and local media sources prior to the events, and with posters and flyers at the venues. There will also be prior liaison with the State’s GPs via both Primary Health Tasmania and the RACGP.
The screen will utilise an automatic blood pressure device that incorporates a specific algorithm to detect AF (Microlife WatchBP Home-A). The UK National Institute for Health and Care Excellence has recommended this device for AF screening. It has high sensitivity and specificity, and has been used in programs internationally. A registered health practitioner or health student will perform the screenings.
Every participant will be provided with educational information on AF (including Stroke Foundation resources). If the presence of AF is suspected, the project team will advise the participant and ensure they understand it is not a definitive diagnosis and that they should make an appointment to see their GP for review. They will be given specific information to take to their GP. The GPs of individuals with a suspected diagnosis of AF upon screening will also be directly contacted by telephone. A follow-up 12-lead ECG is the current gold standard used to confirm the presence of AF. The project team will contact each participant with suspected AF approximately one month after their screening, to ensure they have not been lost to follow-up and to determine the outcome of the initial screening.
Because the Microlife device also accurately measures blood pressure, any participants with high readings (above 160/100 mmHg) will also be provided with information on hypertension and referred to their GP.
The screening procedure is simple, non-invasive and painless, so the risk of harm is minimal. The process is quick, and the high sensitivity and specificity means the outcome can bring swift and reliable assurance; more than 95% of those screened can be reassured at the point of testing.
The study data will be largely presented as a simple descriptive summary of the outcomes from the AF public screening program, incorporating information collected at the one-month follow-up of those participants with suspected AF e.g. rates of detection of previously undiagnosed AF (with analyses by age and gender etc.), rates of false positives based on subsequent GP assessment, AF management initiated. We will also perform a simple economic analysis of the screening program, based on the costs and the anticipated reduction in healthcare costs associated with strokes prevented by the program.
Personal identifying details (name, address, telephone number) will only be collected, with consent, from those individuals in whom the screening reveals that the presence of AF is suspected (likely to be only about 2% of those screened). This is an essential safeguard to (i) contact and advise the GPs of individuals with a suspected diagnosis of AF upon screening and (ii) contact each participant with suspected AF approximately one month after the screening, to ensure they have not been lost to follow-up and to determine the outcome of the initial screening.
Intervention code [1] 300399 0
Early detection / Screening
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304877 0
Based on subsequent GP assessment, the rate of detection of previously undiagnosed AF (with analyses by age and gender etc.), To be determined by patient-report at follow-up.
Timepoint [1] 304877 0
One month after initial screening
Primary outcome [2] 304915 0
AF management initiated, if positive screening result was subsequently confirmed by GP. To be determined by patient-report at follow-up.
Timepoint [2] 304915 0
One month after initial screening
Secondary outcome [1] 343450 0
Rates of false positives from screening, based on subsequent GP assessment. To be determined by patient-report at follow-up.
Timepoint [1] 343450 0
One month after initial screening

Eligibility
Key inclusion criteria
Aged 65 years or older, without known AF.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with an existing cardiac arrhythmia/pacemaker will be excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will screen approximately 1,500 older Tasmanians. Screening sessions will take place on approximately 100 occasions throughout most of 2018 and early 2019 (April 2018-March 2019) at a range of community and organisation venues across Tasmania. The study data will be largely presented as a simple descriptive summary of the outcomes from the AF public screening program, incorporating information collected at the one-month follow-up of those participants with suspected AF e.g. rates of detection of previously undiagnosed AF (with analyses by age and gender etc.), rates of false positives based on subsequent GP assessment, AF management initiated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
2/04/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
28/06/2019
Actual
Sample size
Target
1500
Accrual to date
900
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 298754 0
Charities/Societies/Foundations
Name [1] 298754 0
Tasmanian Community Fund
Country [1] 298754 0
Australia
Funding source category [2] 298757 0
University
Name [2] 298757 0
University of Tasmania
Country [2] 298757 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Ave
SANDY BAY
TAS 7005
Country
Australia
Secondary sponsor category [1] 297930 0
None
Name [1] 297930 0
Address [1] 297930 0
Country [1] 297930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299691 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 299691 0
Ethics committee country [1] 299691 0
Australia
Date submitted for ethics approval [1] 299691 0
19/02/2018
Approval date [1] 299691 0
29/03/2018
Ethics approval number [1] 299691 0
H17129

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2444 2444 0 0
/AnzctrAttachments/374563-Protocol and appendices.pdf (Protocol)

Contacts
Principal investigator
Name 81310 0
Prof Gregory Peterson
Address 81310 0
Bag 26
University of Tasmania
HOBART
TAS 7001
Country 81310 0
Australia
Phone 81310 0
+61 3 6226 2197
Fax 81310 0
Email 81310 0
[email protected]
Contact person for public queries
Name 81311 0
Gregory Peterson
Address 81311 0
Bag 26
University of Tasmania
HOBART
TAS 7001
Country 81311 0
Australia
Phone 81311 0
+61 3 6226 2197
Fax 81311 0
Email 81311 0
[email protected]
Contact person for scientific queries
Name 81312 0
Gregory Peterson
Address 81312 0
Bag 26
University of Tasmania
HOBART
TAS 7001
Country 81312 0
Australia
Phone 81312 0
+61 3 6226 2197
Fax 81312 0
Email 81312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Was not part of approved ethics


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.