ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000622505

Ethics application status

Approved

Date submitted

3/06/2015

Date registered

16/06/2015

Date last updated

19/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Atrial fibrillation (AF) screening using a smartphone electrocardiogram (ECG): pilot study to test implementation in the primary care setting.

Scientific title

Identifying atrial fibrillation (AF) in patients aged 65 years and over by opportunistic screening during the annual influenza vaccination using a smartphone electrocardiogram: pilot study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

GP SEARCH AF

Linked study record

Health condition

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

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Five General practices will participate in the pilot intervention. Nurses at the participating practices will attend a two-hour training session with a trained cardiac nurse specialist. The practice nurse will receive training regarding the research protocol and the use of an approved handheld ECG monitoring device (AliveCor Heart Monitor, ARTG Identifier 208100). This is a special cover that attaches to smartphones, and enables a single lead ECG to be taken using an application on the phone (iECG). Practice nurses will use the ECG device to screen for AF during the period of observation of the patient after the administration of the annual flu shot in general practice. The patient will be asked to hold the smartphone ECG for approximate one minute, to record their heart rhythm. The smartphone application immediately analyses the ECG rhythm for the presence of AF using a validated algorithm, and provides an immediate provisional diagnosis on the smartphone. The ECG recording and provisional diagnosis are directly imported into the general practice software and attached to the patient notes.

The nurse will facilitate a general practitioner review for all patients with a provisional diagnosis of AF, if they have no previous known history of AF. The general practitioner will review the patient and determine subsequent management.

The screening intervention will run for the entire 2015 flu-vax period, approximately 2-3 months in total. Following completion of the intervention, structured interviews will be conducted with the participating nurses, practice managers and a selection of general practitioners from each practice to determine the barriers and enablers of the screening intervention and thereby inform refinement of the larger scale intervention.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Implementation success as assessed through process measures including: the proportion of eligible patients at each practice who attended for their flu vaccination and were screened according to the protocol; time taken to complete the intervention (measured and reported by the participating practice nurses); barriers affecting implementation of screening including competing demands for practice nurse time (measured using semi-structured interviews with the participating practice nurses, practice managers and a selection of general practitioners from each practice); and enablers and benefits of screening (measured using semi-structured interviews with the participating practice nurses, practice managers and a selection of general practitioners from each practice).

Timepoint [1]

Completion of the screening intervention

Secondary outcome [1]

Acceptability of the intervention according to the general practice staff involved in the intervention (measured using semi-structured interviews with the participating practice nurses, practice managers and a selection of general practitioners from each practice)

Timepoint [1]

Completion of screening intervention

Secondary outcome [2]

The proportion of people screened with newly diagnosed AF, identified on the smartphone ECG and confirmed with a subsequent 12-lead ECG (reported as number identified and percentage of total screened)

Timepoint [2]

Completion of screening intervention

Eligibility

Key inclusion criteria

Patients aged 65 years and over, who are eligible for an annual flu shot.

A convenience sample of General Practice will be selected from those who respond to the expression of interest for participation in the pilot study. General practices will need to offer annual flu-vaccination administered by a practice nurse, and need to have onsite wi-fi and a computerized patient management system to be considered eligible for participation. The first 5 eligible practices that respond to the expression of interest will be recruited to the study.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Insufficient cognitive capacity to understand the consent process

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)

Allocation is not concealed

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

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A detailed process evaluation using mixed methods will be undertaken to evaluate iECG screening process. Realist evaluation will be used to analyse the interaction of context, mechanisms for change and the outcomes that are produced. A selection of GPs, practice nurses and patients from each practice will be asked to participate in semi- structured interviews, tailored to each group. In this way we will piece together a detailed understanding of how the intervention influenced the capacity, opportunity and motivation of providers and patients to improve detection and evidence based treatment of AF.

New episodes of AF will be expressed as true positives divided by total number screened with accompanying 95% confidence intervals. Continuous variables will be reported as means +/- standard deviations (SD), and categorical variables as numbers and percentages.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/04/2015

Actual

15/04/2015

Date of last participant enrolment

Anticipated

31/07/2015

Actual

24/07/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

1000

Accrual to date

Final

1044

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Anonymous philanthropic medical foundation

Address [1]

Not applicable

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

City Road, Darlington NSW 2008

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics committee

Ethics committee address [1]

University of Sydney
City Road Darlington NSW 2008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/11/2014

Approval date [1]

16/12/2014

Ethics approval number [1]

2014/962

Summary

Brief summary

Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 1 in 4 adults worldwide, and 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. Almost one in every three strokes is AF-related, and AF-related strokes are likely to be more severe, with a whole of life cost of each stroke estimated at $103,566. However, strokes in AF can be effectively prevented using oral anticoagulants.

Many people in the general population are unaware that they have AF, with first diagnosis being made when they are admitted to hospital with a stroke or transient ischaemic attack. The diagnosis of unknown AF can be easily made using a 30 second ECG rhythm strip obtained with a TGA approved smartphone ECG (iECG). Using this device, unknown AF can be identified and treated, thus reducing the number of strokes due to AF. We have previously shown that community screening for AF to prevent stroke is likely to be cost-effective, but the magnitude of the benefit in terms of numbers of strokes prevented, is determined by the proportion of the population screened. 

The current study therefore explores screening for AF in primary care, by performing iECG screening during annual influenza vaccination currently administered to over 70% of patients aged 65 years and over in general practice. This opportunistic method of screening, through its reach, would approximate systematic population screening for AF. Screening will be performed in a small number of practices in this pilot study to optimize the process and inform any refinement of a larger scale study of implementation. The pilot will also ensure the tools are ready for the larger implementation study.

Trial website

Nil

Trial related presentations / publications

Public notes

Nil

Contacts

Principal investigator

Name

Dr Lis Neubeck

Address

Level 2, Building D17
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 8627 0291

Fax

lis.neubeck@sydney.edu.au

Contact person for public queries

Name

S Ben Freedman

Address

Level 2, Building D17
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9767 7358

Fax

Ben.Freedman@sydney.edu.au

Contact person for scientific queries

Name

Lis Neubeck

Address

Level 2, Building D17
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 8627 0291

Fax

lis.neubeck@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

Source	Title	Year of Publication	DOI
Embase	Screening for atrial fibrillation during influenza vaccinations by primary care nurses using a smartphone electrocardiograph (iECG): A feasibility study.	2016	https://dx.doi.org/10.1177/2047487316670255

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

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Documents added manually

Documents added automatically