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Trial registered on ANZCTR


Registration number
ACTRN12613000429752
Ethics application status
Approved
Date submitted
12/04/2013
Date registered
16/04/2013
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening Education And Recognition by primary Care pHysician of Atrial Fibrillation for prevention of stroke (SEARCH-AF II)
Scientific title
In an ambulatory population over 65 years of age attending general practices, is a handheld single-lead ECG attached to an iPhone an acceptable and effective screening tool to identify atrial fibrillation?
Secondary ID [1] 282161 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SEARCH-AF II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation
288669 0
Stroke 288904 0
Condition category
Condition code
Cardiovascular 289014 289014 0 0
Other cardiovascular diseases
Public Health 289015 289015 0 0
Health promotion/education
Stroke 289016 289016 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Receptionists in general practice clinics will be trained to screen eligible patients for atrial fibrillation using a handheld single-lead ECG (the AliveCor Heart Monitor for iPhone). This will be a one-off screening of approximately 30 seconds duration. Following the screening, the iPhone will transmit a pdf of the ECG recording to a secure website toghether with an automated computer diagnosis of whether the patient is likely to have atrial fibrillation or not. During the patient's consultation, the GP will log in to the secure website and review the ECG. The GP will advise the patient if any additional treatment is required.

The screening trial will be conducted over a 6 month period.
Intervention code [1] 286770 0
Early detection / Screening
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289133 0
The feasibility and acceptability of screening for AF using a hand-held single-lead ECG device in people aged 65 years and over in the general practice setting. A detailed process evaluation will be undertaken to assess these outcomes. As part of this evaluation, selected patients, GPs and reception staff will be asked to participate in semi-structured interviews. The audio from these interviews will be recorded, then coded and analysed using grounded theory.
Timepoint [1] 289133 0
At completion of screening period.
Primary outcome [2] 289134 0
The satisfaction of GPs, reception staff and patients with the screening process in the general practice setting. As noted above in relation to primary outcome 1, this will be assessed through semi-structured interviews of selected GPs, reception staff and patients.
Timepoint [2] 289134 0
During and after the screening process.
Secondary outcome [1] 301900 0
Process measures, such as the time taken to complete the intervention, competing demands for practice reception staff time, and the attitudes of patients and staff involved in the intervention. As noted above in relation to primary outcome 1, this will be assessed through semi-structured interviews of selected GPs, reception staff and patients.
Timepoint [1] 301900 0
During and after the screening process.
Secondary outcome [2] 301901 0
Barriers (including technological barriers), enablers and other information relevant to the process of developing a larger-scale implementation study. This will be assessed through semi-structured interview data together with any other information gathered by the research team during the conduct of the study either directly or from any of the involved general practices.
Timepoint [2] 301901 0
At completion of screening period.

Eligibility
Key inclusion criteria
People will be eligible to participate if they are attending the general practice for a consultation with their GP and are aged 65 years or over.

Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include:
a. diagnosis of a severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness); or
b. the inability to read/understand the consent form and participant information statement in English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286932 0
Commercial sector/Industry
Name [1] 286932 0
Bristol-Myers Squibb Company
Address [1] 286932 0
345 Park Avenue
New York, New York
10154
Country [1] 286932 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
The George Institute for Global Health
Address
Level 10, King George V Building
83-117 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 285721 0
University
Name [1] 285721 0
The University of Sydney
Address [1] 285721 0
The University of Sydney
NSW 2006
Country [1] 285721 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288988 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 288988 0
Human Ethics
University of Sydney NSW 2006
Ethics committee country [1] 288988 0
Australia
Date submitted for ethics approval [1] 288988 0
06/02/2013
Approval date [1] 288988 0
01/03/2013
Ethics approval number [1] 288988 0
2013/135

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.


The study is designed to examine the feasibility of screening to identify undiagnosed AF in a primary care setting. Our hypothesis is that a simple primary care screening program may be effective in detecting those
with undiagnosed AF. The specific aims are to:
1. Assess the feasibility and acceptability of screening for AF using a hand-held single-lead ECG device in people aged 65 years and over in the general practice setting.
2. Assess the satisfaction of GPs, reception staff and patients with the screening process in the general practice setting.
3. Examine process measures, such as the time taken to complete the intervention, competing demands for practice reception staff time, and the attitudes of patients and staff involved in the intervention.
4. Identify barriers (including technological barriers), enablers and other information relevant to the process of developing a larger-scale implementation study.

We propose a cross-sectional study offered in up to 5 general practices in the Sydney metropolitan area. People aged 65 and over, attending general practices will be invited to volunteer for the screening.

The screening will consist of an assessment with a handheld single-lead ECG device attached to an iPhone by the practice receptionist. This ECG will be transmitted to a secure website and reviewed by the patient's GP during their consultation.

The primary outcome measure will be the acceptability of the screening process. A process evaluation will also be undertaken to better appreciate factors that might influence sustainability beyond the trial setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38650 0
Dr Lis Neubeck
Address 38650 0
Senior Research Fellow, Cardiovascular
Adjunct Senior Lecturer, Sydney Nursing School, University of Sydney
Level 10, King George V Building
83-117 Missenden Rd
Camperdown NSW 2050
Country 38650 0
Australia
Phone 38650 0
+61 2 8507 2521
Fax 38650 0
Email 38650 0
lis.neubeck@sydney.edu.au
Contact person for public queries
Name 38651 0
Ms Jessica Orchard
Address 38651 0
Level 2, Charles Perkins Centre (D17)
University of Sydney
NSW 2006
Country 38651 0
Australia
Phone 38651 0
+61 2 8627 1644
Fax 38651 0
Email 38651 0
jessica.orchard@sydney.edu.au
Contact person for scientific queries
Name 38652 0
Dr Lis Neubeck
Address 38652 0
Senior Research Fellow, Cardiovascular
Adjunct Senior Lecturer, Sydney Nursing School, University of Sydney
Level 10, King George V Building
83-117 Missenden Rd
Camperdown NSW 2050
Country 38652 0
Australia
Phone 38652 0
+61 2 8507 2521
Fax 38652 0
Email 38652 0
lis.neubeck@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary