ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616000850471

Ethics application status

Approved

Date submitted

14/06/2016

Date registered

29/06/2016

Date last updated

4/03/2019

Date data sharing statement initially provided

4/03/2019

Date results provided

4/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Atrial fibrillation screening with smartphone ECG: implementation in a primary care setting

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

AF SMART

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

Ten general practices will participate in the intervention-based study. Nurses at these practices will attend a one hour training session with a researcher. The session will feature a brief presentation on atrial fibrillation (AF), study protocol, and the use of an approved handheld iECG device (Kardia Mobile, ARTG Identifier 234417) and two accompanying mobile applications (Kardia and AliveCare).

The Kardia device is a portable iECG monitor that attaches to smartphones. It enables a single lead iECG to be taken using the Kardia application on the smartphone after a patient places two fingers on the electrodes. 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 or during chronic care assessments in general practice. Chronic care assessments in general practice is usually over 30 minutes which allows more time for AF screening. They include annual Diabetes Cycle of Care and health assessment for people aged 75 years and older which are funded under the current Medicare Scheme. During screening, the patient will be asked to hold the smartphone ECG for a minimum of thirty seconds to record their heart rhythm. The Kardia 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 recordings and provisional diagnoses are directly imported into the general practice’s local server. Staff can download them as PDFs to attach to patient files in the clinical management system. These results are also saved simultaneously through Wi-Fi connection to the AliveCor and AliveCare websites for secure online viewing. Secure access is granted to the researchers and practice staff directly involved in patient care. Data presented to the researchers are all de-identified.

For this study the practice nurses will facilitate a general practitioner review for all patients with a provisional diagnosis of AF, if they have no previous known history of this condition. Review of known AF patients’ current management plan is also recommended particularly if they are not being treated by anti-coagulants. The general practitioner will determine subsequent management strategy for both new and known AF patients using an electronic decision-support system (EDS) called HealthTracker-CVD. This system is developed by the George Institute in collaboration with Sydney University. It sits within the practice software (Medical Director or Best Practice) to provide healthcare staff with evidence-based guidelines for optimal therapeutic management of AF.

The screening intervention will commence in late 2016 and run for the entire 2017 flu vaccination as well as chronic care assessments within that period. Following completion of the intervention, semi-structured interviews will be conducted with the participating nurses, practice managers, and a selection of general practitioners from each practice to identify barriers and enablers of workflow as well as the usefulness of EDS

Intervention code [1]

Early detection / Screening

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Implementation success through process measures including proportion of eligible patients screened, fidelity to the protocol, and time taken to complete the intervention. Proportion of eligible patients screened will be calculated based on the number of patients screened for AF in proportion to the total number of patients eligible for annual flu shot and chronic care assessments in each participating GP clinic. Fidelity to protocol and time taken to complete the intervention will be assessed using semi-structured interviews with practice nurses, practice managers and selected general practitioners from participating clinics.

Timepoint [1]

Completion of the screening intervention.

Secondary outcome [1]

Cost effectiveness analysis (i.e. incremental cost-effectiveness ratio of screening per quality adjusted life year gained, and per stroke avoided– using an adaptation of the basic economic model for AF screening developed and utilised in the SEARCH-AF study)

SEARCH-AF study:
Lowres, N., Neubeck, L., Salkeld, G., Krass, I., McLachlan, A. J., Redfern, J., ... & Wallenhorst, C. (2014). Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost, 111(6), 1167-76.

Timepoint [1]

Completion of the screening intervention.

Secondary outcome [2]

The proportion of people screened identified with actionable AF. This will be assessed by reviewing Kardia iECG results. The percentage of people identified with actionable AF will be calculated based on their number in proportion to the total number of people screened.

Timepoint [2]

Completion of the screening intervention.

Secondary outcome [3]

To identify the competing demands, barriers, enablers and assess the level of acceptability according to staff involved in the intervention. AF screening during flu vaccination, chronic care assessment, and random GP referral will be compared to find out the most effective mode of delivery. This will be assessed as part of the process evaluation.

This composite outcome will be assessed using semi-structured interviews with practice nurses, practice managers, and selected general practitioners from each participating clinic.

Timepoint [3]

Completion of the screening intervention.

Eligibility

Key inclusion criteria

Patients aged 65 years and over who are attending the general practice for flu vaccination and/or chronic care assessments.

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

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2016

Actual

15/11/2016

Date of last participant enrolment

Anticipated

30/09/2018

Actual

31/07/2018

Date of last data collection

Anticipated

Actual

31/08/2018

Sample size

Target

4000

Accrual to date

Final

1806

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart Foundation Australia

Address [1]

Unit 1, Level 1, 17-23 Townshend Street, Phillip ACT 2606

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]

Not applicable

Address [1]

Not applicable

Country [1]

Other collaborator category [1]

Other

Name [1]

The George Institute for Global Health

Address [1]

Level 10, King George V Building, Royal Prince Alfred Hospital, Missenden Rd
Camperdown NSW 2050

Country [1]

Australia

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]

Approval date [1]

16/12/2014

Ethics approval number [1]

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. Unfortunately in Australia oral anticoagulant prescription is only about 60% even in those patients with known AF who are therefore at high risk for stroke. This gap has been difficult to close despite having therapeutic management guidelines.

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. 

This 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 or over in general practice. Screening will also take place during annual chronic care assessments such as Diabetes Cycle of Care and Health Assessment for People Aged 75 and Older. This opportunistic method of screening, through its reach, could approximate systematic population screening for AF. Screening will be performed in 10 practices across NSW to gauge and efficacy and cost effectiveness of community-based AF screening. In addition to the handheld iECG device, this study will also implement the electronic decision support software called HealthTracker-CVD. A special AF module has been designed as part of this software to automatically calculate the stroke risk score for patients with AF, and provide individualised advice on evidence-based management of AF. An automated tool such as this available to both general practitioners and practice nurses is ideal to facilitate closing the gap in oral anticoagulant prescription for stroke prevention in patients with diagnosed AF.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nicole Lowres

Address

Level 2, Building D17 Charles Perkins Centre
The University of Sydney
NSW
2006

Country

Australia

Phone

+61 2 8627 5940

Fax

nicole.lowres@sydney.edu.au

Contact person for public queries

Name

Jessica Orchard

Address

Level 2, Building D17 Charles Perkins Centre
The University of Sydney
NSW
2006

Country

Australia

Phone

+61 2 8627 1664

Fax

jessica.orchard@sydney.edu.au

Contact person for scientific queries

Name

Ben Freedman

Address

Level 3, Building D17 Charles Perkins Centre
The University of Sydney
NSW
2006

Country

Australia

Phone

+61 411 591 633

Fax

ben.freedman@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Not permitted by our ethics approval

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.	2017	https://dx.doi.org/10.1161/CIRCULATIONAHA.116.026693
Embase	eHealth tools to provide structured assistance for atrial fibrillation screening, management, and guideline-recommended therapy in metropolitan general practice: The AF-SMART study.	2019	https://dx.doi.org/10.1161/JAHA.118.010959
Embase	Uptake of a primary care atrial fibrillation screening program (AF-SMART): a realist evaluation of implementation in metropolitan and rural general practice.	2019	https://dx.doi.org/10.1186/s12875-019-1058-9

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically