Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000459426
Ethics application status
Approved
Date submitted
3/04/2016
Date registered
7/04/2016
Date last updated
7/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Is opportunistic screening appropriate for identifying arrhythmias and establishing effective clinical pathways for Aboriginal Australians?
Scientific title
Is opportunistic screening appropriate for identifying arrhythmias and establishing effective clinical pathways for Aboriginal Australians?
Secondary ID [1] 288919 0
None
Universal Trial Number (UTN)
U1111-1181-5344
Trial acronym
AAiECG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 298252 0
cardiovascular disease 298253 0
stroke 298254 0
Condition category
Condition code
Cardiovascular 298398 298398 0 0
Diseases of the vasculature and circulation including the lymphatic system
Public Health 298399 298399 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Opportunistic screening of Aboriginal people over 45 years using a portable ECG attached to a smart phone.
1. The screening will be undertaken by local Aboriginal health workers supervised by a Registered Nurse.
2. All health workers (known as screeners in the study) will receive one day of training of face to face training.
3. They will receive daily support from a Registered Nurse. All screeners will report patients with a non-normal result for follow up by the Registered Nurse.
4. All participants will be formally consented into the study by a local Aboriginal person and receive health literacy information as well as a participant information sheet. The health literacy will be in the form of a printed sheet in plain English and pictorial form. We are seeking advice of Aborignal health literacy experts in design, and the content will be approved by cardiologist Prof Ben Freedman. This resource is expected to be drafted for review by mid-April.
5. The screening will occur in the usual course of the workers duties in the Aboriginal Health Service, health clinic, pharmacy, home visit or community centre.
6. The screeners will undertake a 30 second screen by asking the patient to hold onto a small probe attached to a smart phone. The process is painless and quick, and a result appears on the smart phone App.
7. There are three possible results: normal; Atrial Fibrillation; or unreadable.
8. Anyone screened with result other than Normal will be referred for a 12-lead ECG to confirm the diagnosis and plan further assessment and treatment as indicated.
9. Each eligible patient will be screened once. Each screener will undertake 50 screens with eligible patients. There are 30 screeners in the study and each screener is supervised and supported by a Registered Nurse.
10. The host organisation will retain the device for use in their practice once the 50 screens have been included in the study.
11. Host organisations each have an investigator on the study and several members of the Investigators team are Aboriginal.
12. The Principal Investigator will have weekly teleconferences with the Registered Nurses about progress and issues.
Intervention code [1] 294382 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297873 0
Estimate prevalence of Atrial Fibrillation in Aboriginal Australians using portable ECG results.
Timepoint [1] 297873 0
At the end of the study
Secondary outcome [1] 322497 0
Evaluate the effectiveness of opportunistic screening using an iECG for Australian Aboriginal people using semi structured interviews with Aboriginal health workers.
Timepoint [1] 322497 0
At the end of the study.

Eligibility
Key inclusion criteria
Aboriginality; aged 45 years or over; Australian
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
non-Aboriginal people; people under 45 years

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)
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
Mixed methods. In addition to opportunistic screening data, the study will conduct semi-structured interviews with screeners to determine effectiveness of the process in achieving the intended outcome.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis of screening data and thematic analysis of qualitative data. 1500 screens across three jurisdictions will enable an estimate of prevalence. No power calculation has been performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2016
Actual
Date of last participant enrolment
Anticipated
22/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,WA
Recruitment hospital [1] 5540 0
Brewarrina Multi Purpose Service - Brewarrina
Recruitment hospital [2] 5541 0
Mungindi Hospital - Mungindi
Recruitment postcode(s) [1] 13007 0
2839 - Brewarrina
Recruitment postcode(s) [2] 13008 0
6530 - Geraldton
Recruitment postcode(s) [3] 13009 0
2360 - Inverell
Recruitment postcode(s) [4] 13010 0
2409 - Boggabilla
Recruitment postcode(s) [5] 13011 0
2406 - Mungindi
Recruitment postcode(s) [6] 13012 0
0870 - Alice Springs
Recruitment postcode(s) [7] 13013 0
2440 - Kempsey
Recruitment postcode(s) [8] 13014 0
2372 - Tenterfield
Recruitment postcode(s) [9] 13015 0
2370 - Glen Innes
Recruitment postcode(s) [10] 13016 0
2361 - Ashford
Recruitment postcode(s) [11] 13017 0
2369 - Tingha

Funding & Sponsors
Funding source category [1] 293268 0
Other
Name [1] 293268 0
Heart Research Institute
Country [1] 293268 0
Australia
Primary sponsor type
University
Name
Poche Centre for Indigenous Health, The University of Sydney
Address
Rm 223 Edward Ford Building A27, The University of Sydney 2006 NSW
Country
Australia
Secondary sponsor category [1] 292069 0
Other
Name [1] 292069 0
Heart Research Institute
Address [1] 292069 0
3 Eliza St Newtown NSW 2042
Country [1] 292069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294746 0
Aboriginal Health and Medical Research Council
Ethics committee address [1] 294746 0
3/66 Wentworth Ave, Surry Hills NSW 2010
Ethics committee country [1] 294746 0
Australia
Date submitted for ethics approval [1] 294746 0
26/10/2015
Approval date [1] 294746 0
17/12/2015
Ethics approval number [1] 294746 0
1135/15

Summary
Brief summary
Background: The leading cause of death for Aboriginal Australians is cardiovascular disease, including stroke and heart attack. Atrial Fibrillation is a precursor to stroke. There are no published studies about the prevalence of Atrial Fibrillation for Aboriginal people. The purpose of the study is twofold: to estimate prevalence of Atrial Fibrillation in Australian Aboriginal people and evaluate the effectiveness of opportunistic screening, and assessment and treatment pathways for Aboriginal people with Atrial Fibrillation or other arrhythmias.
Methods: This is a mixed methods study which will screen 1500 Australian Aboriginal people living in New South Wales, Northern Territory or Western Australia to estimate prevalence of Atrial Fibrillation. This data will be analysed statistically to estimate prevalence. In addition, the study will conduct semi-structured interviews with Aboriginal workers who conduct the screens to evaluate qualitatively the effectiveness of opportunistic screening using an iECG to facilitate timely assessment and treatment for Aboriginal people over 45 years.
Discussion: The study aims to determine the feasibility of the portable iECG device to diagnose abnormal heart rhythm in Aboriginal people and facilitate access to further assessment and treatment; estimate the prevalence of AF in Aboriginal people in Australia; improve health literacy in Aboriginal people and health workers; and help prevent the effects of untreated AF in Aboriginal people; including ischemic stroke and prevent early deaths or impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63190 0
Ms Kylie Gwynne
Address 63190 0
Rm 223 Edward Ford Building A27 The University of Sydney 2006 NSW
Country 63190 0
Australia
Phone 63190 0
+61 2 9036 6494
Fax 63190 0
+61 2 9351 3196
Email 63190 0
[email protected]
Contact person for public queries
Name 63191 0
Ms Kylie Gwynne
Address 63191 0
Rm 223 Edward Ford Building A27 The University of Sydney 2006 NSW
Country 63191 0
Australia
Phone 63191 0
+61 2 9036 6494
Fax 63191 0
+61 2 9351 3196
Email 63191 0
[email protected]
Contact person for scientific queries
Name 63192 0
Prof Ben Freedman
Address 63192 0
Room 3114, 3E Charles Perkins Centre, University of Sydney 2006 NSW
Country 63192 0
Australia
Phone 63192 0
+61 411 591 633
Fax 63192 0
+61 2 8212 9058
Email 63192 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
EmbaseOpportunistic screening to detect atrial fibrillation in Aboriginal adults in Australia.2016https://dx.doi.org/10.1136/bmjopen-2016-013576
N.B. These documents automatically identified may not have been verified by the study sponsor.