Trial Review

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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] 286849 0
Nil
Universal Trial Number (UTN)
Trial acronym
GP SEARCH AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 295241 0
Condition category
Condition code
Cardiovascular 295485 295485 0 0
Other cardiovascular diseases
Public Health 295559 295559 0 0
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] 292013 0
Early detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295214 0
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] 295214 0
Completion of the screening intervention
Secondary outcome [1] 315083 0
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] 315083 0
Completion of screening intervention
Secondary outcome [2] 315084 0
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] 315084 0
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] 291404 0
Charities/Societies/Foundations
Name [1] 291404 0
Anonymous philanthropic medical foundation
Country [1] 291404 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Road, Darlington NSW 2008
Country
Australia
Secondary sponsor category [1] 290079 0
None
Name [1] 290079 0
Address [1] 290079 0
Country [1] 290079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292952 0
University of Sydney Human Research Ethics committee
Ethics committee address [1] 292952 0
University of Sydney
City Road Darlington NSW 2008
Ethics committee country [1] 292952 0
Australia
Date submitted for ethics approval [1] 292952 0
07/11/2014
Approval date [1] 292952 0
16/12/2014
Ethics approval number [1] 292952 0
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 57786 0
Dr Lis Neubeck
Address 57786 0
Level 2, Building D17
The University of Sydney
NSW 2006
Country 57786 0
Australia
Phone 57786 0
+61 2 8627 0291
Fax 57786 0
Email 57786 0
[email protected]
Contact person for public queries
Name 57787 0
S Ben Freedman
Address 57787 0
Level 2, Building D17
The University of Sydney
NSW 2006
Country 57787 0
Australia
Phone 57787 0
+61 2 9767 7358
Fax 57787 0
Email 57787 0
[email protected]
Contact person for scientific queries
Name 57788 0
Lis Neubeck
Address 57788 0
Level 2, Building D17
The University of Sydney
NSW 2006
Country 57788 0
Australia
Phone 57788 0
+61 2 8627 0291
Fax 57788 0
Email 57788 0
[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
SourceTitleYear of PublicationDOI
EmbaseScreening for atrial fibrillation during influenza vaccinations by primary care nurses using a smartphone electrocardiograph (iECG): A feasibility study.2016https://dx.doi.org/10.1177/2047487316670255
N.B. These documents automatically identified may not have been verified by the study sponsor.