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Trial registered on ANZCTR


Registration number
ACTRN12612000406808
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
11/04/2012
Date last updated
7/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening Education And Recognition in Community pHarmacies of Atrial Fibrillation to prevent stroke (SEARCH-AF)
Scientific title
Screening Education And Recognition in Community pHarmacies of Atrial Fibrillation for stroke prevention (SEARCH-AF): using pulse check and handheld ECG to identify atrial fibrillation in an ambulatory population aged 65 years and over
Secondary ID [1] 280280 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SEARCH-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 286238 0
Stroke 286252 0
Condition category
Condition code
Cardiovascular 286453 286453 0 0
Other cardiovascular diseases
Public Health 286472 286472 0 0
Health promotion/education
Stroke 286473 286473 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community pharmacists will screen members of the general public for atrial fibrillation using a combination of a manual pulse check and a handheld single-lead ECG (using the AliveCor Heart Monitor for iPhone). This will be a once off screening of approximately 5-10 minutes duration. Following the screening, the pharmacist will contact the participants GP via letter, stating the provisional diagnosis. A cardiologist will review all of the single-lead ECG recordings to ensure the pharmacists interpretation is correct. The GP will be further contacted by the research team if the diagnosis is other than reported by the pharmacist.

The screening trial will be conducted over a 6 month period.
Intervention code [1] 284631 0
Early detection / Screening
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286897 0
Number of newly identified atrial fibrillation in a community cohort aged 65 years and over. Presence of atrial fibrillation will be determined by cardiologist interpretation af the single-lead ECG recording from the AliveCor Heart Monitor for iPhone.
Timepoint [1] 286897 0
At completion of screening period (6 months)
Secondary outcome [1] 296936 0
The level of agreement between the pharmacist's interpretation of the single lead ECG, compared to the cardiologist's interpretation of the single lead ECG
Timepoint [1] 296936 0
At completion of screening period (6 months)
Secondary outcome [2] 296937 0
The level of agreement for identification of an irregular rhythm between pulse taking of the pharmacist and the cardiologists interpretation of single-lead ECG taken from the AliveCore iPhone ECG monitor
Timepoint [2] 296937 0
At completion of screening period (6 months)
Secondary outcome [3] 296938 0
Number of participants that remain in AF, from the positive diagnosis from the single lead ECG from the AliveCore iPhone ECG monitor to the 12-lead ECG performed during review with the cardiologist. Time between single-lead ECG and 12-lead ECG will vary and will be dependent on which cardiologist the GP decides to refer the participant to.
Timepoint [3] 296938 0
At completion of screening period (6 months)
Secondary outcome [4] 296939 0
Pharmacist knowledge of AF (measured with knowledge questionnaire developed specifically for this research trial)
Timepoint [4] 296939 0
At completion of screening period (6 months)

Eligibility
Key inclusion criteria
People will be eligible to participate if they are aged 65 years or over.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include diagnosis of a severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pharmacists will offer members of the general public the opportunity to participate in the screening program. There will also be a sign within the pharmacy advisertising the availability of the screening program, therefore members of the general public may approach the pharmacist about participating.

All participants will receive the same intervention, therefore there is no allocation concealment or randomisation required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2012
Actual
2/06/2012
Date of last participant enrolment
Anticipated
Actual
25/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285046 0
Commercial sector/Industry
Name [1] 285046 0
Bristol-Myers Squibb Company
Country [1] 285046 0
United States of America
Primary sponsor type
Hospital
Name
Concord General Repatriation Hospital
Address
Hospital Road
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 283911 0
University
Name [1] 283911 0
University of Sydney
Address [1] 283911 0
The University of Sydney
NSW 2006
Country [1] 283911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287051 0
Sydney Local Health District Human Research Ethics Committee - CRGH
Ethics committee address [1] 287051 0
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Ethics committee country [1] 287051 0
Australia
Date submitted for ethics approval [1] 287051 0
21/11/2011
Approval date [1] 287051 0
26/03/2012
Ethics approval number [1] 287051 0
HREC/11/CRGH/274

Summary
Brief summary
Atrial fibrillation (AF) is the most common heart arrhythmia affecting at least 240,000 Australians. Prevalence rises
with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to
seven times more likely to have a stroke than the general population, and AF related strokes are also likely to be
more severe. In addition, one in every six strokes is AF related.
Stroke is highly preventable in AF with the use of appropriate thromboprophylaxis.
Therefore early identification and appropriate evidence based management of AF could lead to subsequent stroke prevention, significant reduction in the overall stroke burden and substantial savings to the health system.
Our hypothesis is that a simple community pharmacy based
screening program may be effective in detecting those
with undiagnosed AF. The specific aims are to:
1. To identify the number of newly identified AF in people aged 65 years and over in a pharmacy setting.
2. Determine the feasibility of screening for AF using a pulse check and handheld singlelead electrocardiography
(ECG) device in people aged 65 years and over.
3. Inform refinement of the intervention through the use of process measures with view to establishing a larger
crosssectional study.
4. To increase the skills and knowledge of pharmacists regarding atrial fibrillation screening and management.
We propose a crosssectional study offered in 10 community pharmacies in the districts surrounding the Concord
Hospital. People aged 65 and over, attending community pharmacies will be invited to volunteer for the screening.
The screening will consist of a pulse check, brief medical history including pharmacotherapy and screen of AF
symptoms and an assessment with a handheld singlelead
ECG device. The pharmacist will communicate the
provisional diagnosis to the participants treating general practitioner (GP). For those participants suspected of
having AF, the research team will contact the both the participant and their GP. We will invite the GP to refer their
patient to Concord Hospital cardiology clinic for definitive diagnosis and standard cardiology care as appropriate.
The primary outcome measure will be the number of newly identified atrial fibrillation in a community cohort aged 65
years and over. A process evaluation will also be undertaken to better appreciate factors that might influence
sustainability beyond the trial setting.
Trial website
Nil
Trial related presentations / publications
1. Lowres N, S Ben Freedman, Julie Redfern, Andrew McLachlan, Alexandra Bennett, Ines Krass, Tom Briffa, Adrian Bauman and Lis Neubeck Screening Education And Recognition in Community pHarmacies of Atrial Fibrillation for stroke prevention (SEARCH-AF): Research Protocol. BMJ Open, 2012;2:e001355 doi:10.1136/bmjopen-2012-001355
2. Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, Albert DE and Freedman SB. iPhone ECG application for community screening to detect silent atrial fibrillation: A novel technology to prevent stroke, Int J Cardiol, 2013;165(1):193-4.
3. Lowres N, Neubeck L, Redfern J, McLachlan A, Krass I, Bennet A, Briffa T, Salkeld G, Brieger DB, Sy RW, Bauman A and Freedman SB. Screening Education And Recognition in Community pHarmacies of Atrial Fibrillation to prevent stroke (SEARCH-AF stroke prevention study). Heart Lung Circ, 2013;22(Suppl 1):s223
4. Lau J, Lowres N, Neubeck L, Brieger D, Sy R, Albert D, Freedman SB. Validation of an iPhone ECG application suitable for community screening for silent atrial fibrillation: a novel way to prevent stroke. Circulation. 2012;126:A16810
5. Lau J, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway C, Albert DE, Freedman SB. Performance of an Automated iPhone ECG Algorithm to Diagnose Atrial Fibrillation in a Community AF Screening Program (SEARCH-AF). Heart Lung Circ, 2013;22(Suppl 1):s205
6. Lowres N, Neubeck L, Salkeld G, et al. Feasibility and cost effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost 2014;111. doi 10.1160/th14-03-0231
Public notes

Contacts
Principal investigator
Name 34027 0
Prof S Ben Freedman
Address 34027 0
Cardiology Department Concord Repatriation General Hospital Hospital Road Concord NSW 2139
Country 34027 0
Australia
Phone 34027 0
+61-2-9767-7358
Fax 34027 0
Email 34027 0
ben.freedman@sydney.edu.au
Contact person for public queries
Name 17274 0
Nicole Lowres
Address 17274 0
Suite 108 Medical Centre
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 17274 0
Australia
Phone 17274 0
+612 9767 6345
Fax 17274 0
Email 17274 0
nicole.lowres@sydney.edu.au
Contact person for scientific queries
Name 8202 0
Prof Ben Freedman
Address 8202 0
Cardiology Department
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 8202 0
Australia
Phone 8202 0
+61-2-9767-7358
Fax 8202 0
Email 8202 0
ben.freedman@sydney.edu.au

No information has been provided regarding IPD availability


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
Dimensions AIScreening Education And Recognition in Community pHarmacies of Atrial Fibrillation to prevent stroke in an ambulant population aged =65 years (SEARCH-AF stroke prevention study): a cross-sectional study protocol2012https://doi.org/10.1136/bmjopen-2012-001355
EmbaseEffectiveness of systematic screening for the detection of atrial fibrillation.2013https://dx.doi.org/10.1002/14651858.CD009586.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.