ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

SEARCH-AF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial Fibrillation

Stroke

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Public Health

Health promotion/education

Stroke

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]

Early detection / Screening

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At completion of screening period (6 months)

Secondary outcome [1]

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]

At completion of screening period (6 months)

Secondary outcome [2]

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]

At completion of screening period (6 months)

Secondary outcome [3]

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]

At completion of screening period (6 months)

Secondary outcome [4]

Pharmacist knowledge of AF (measured with knowledge questionnaire developed specifically for this research trial)

Timepoint [4]

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]

Commercial sector/Industry

Name [1]

Bristol-Myers Squibb Company

Address [1]

345 Park Avenue
New York, New York
10154

Country [1]

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]

University

Name [1]

University of Sydney

Address [1]

The University of Sydney
NSW 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee - CRGH

Ethics committee address [1]

Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2011

Approval date [1]

26/03/2012

Ethics approval number [1]

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

Prof S Ben Freedman

Address

Cardiology Department Concord Repatriation General Hospital Hospital Road Concord NSW 2139

Country

Australia

Phone

+61-2-9767-7358

Fax

Email

[email protected]

Contact person for public queries

Name

Nicole Lowres

Address

Suite 108 Medical Centre
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+612 9767 6345

Fax

Email

[email protected]

Contact person for scientific queries

Name

Prof Ben Freedman

Address

Cardiology Department
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+61-2-9767-7358

Fax

Email

[email protected]

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

Source	Title	Year of Publication	DOI
Dimensions AI	Screening 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 protocol	2012	https://doi.org/10.1136/bmjopen-2012-001355
Embase	Effectiveness of systematic screening for the detection of atrial fibrillation.	2013	https://dx.doi.org/10.1002/14651858.CD009586.pub2

N.B. These documents automatically identified may not have been verified by the study sponsor.