Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001107112
Ethics application status
Approved
Date submitted
26/07/2019
Date registered
12/08/2019
Date last updated
21/10/2021
Date data sharing statement initially provided
12/08/2019
Date results provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The hEart oF ethiopia: Focus on Atrial Fibrillation screening (TEFF-AF)
Scientific title
The hEart oF ethiopia: Focus on Atrial Fibrillation screening
Secondary ID [1] 298851 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TEFF-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 313802 0
Condition category
Condition code
Cardiovascular 312214 312214 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Any person eligible for screening will be asked to participate and provided with written information about the study. The process of screening will be explained including the sharing of the screening results with their general practitioner/family physician. The screening will be free of charge to the participants and verbal informed consent will be obtained prior to conducting the screening. The screening protocol will take approximately 5-10 minutes and includes the following:
i) Initial brief medical history to include capturing of co-existing medical condition(s) and medication history;
ii) Measurements of weight, height and blood pressure with an automated machine. If the resting blood pressure is elevated (Systolic >130mmHg), an additional reading will be performed.
iii) Single lead ECG recording of 30-60s using the AliveCor Kardia device. The automated diagnostic function of the device will provide on the spot analysis as “normal” or “Possible Atrial Fibrillation".
Intervention code [1] 315117 0
Early Detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320853 0
Proportion of screened subjects with newly identified or pre-existing AF, identified by ECG screening, to derive population prevalence.
Timepoint [1] 320853 0
Participant screening outcome will be determined at occasion of enrollment. No follow up is performed
Secondary outcome [1] 373058 0
Proportion of screened subjects with newly identified or pre-existing hypertension, identified by blood pressure measurement using sphygmomanometer, to derive population prevalence.
Timepoint [1] 373058 0
Participant screening outcome will be determined at occasion of enrollment. No follow up is performed
Secondary outcome [2] 373059 0
To delineate the risk factor profile leading to AF, by participant completion of a customize medical history questionnaire.
Timepoint [2] 373059 0
Participant screening outcome will be determined at occasion of enrollment. No follow up is performed

Eligibility
Key inclusion criteria
Aged 18 years and above, identifying as Ethiopian and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be performed using SPSS (IBM inc.). We anticipate mainly descriptive statistics, t-tests (for normally distributed data) and Wilcoxon signed-rank tests (for non-parametric data)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2019
Actual
15/08/2019
Date of last participant enrolment
Anticipated
31/07/2020
Actual
8/08/2020
Date of last data collection
Anticipated
31/07/2020
Actual
8/08/2020
Sample size
Target
3000
Accrual to date
Final
3000
Recruitment outside Australia
Country [1] 21715 0
Ethiopia
State/province [1] 21715 0

Funding & Sponsors
Funding source category [1] 303399 0
Self funded/Unfunded
Name [1] 303399 0
Dr Dennis Lau
Country [1] 303399 0
Australia
Primary sponsor type
Individual
Name
Dr Dennis Lau
Address
Centre for Heart Rhythm Disorders of The University of Adelaide.
Cardiology 4G751-769
Royal Adelaide Hospital
Port Rd, SA 5000
Country
Australia
Secondary sponsor category [1] 303441 0
None
Name [1] 303441 0
Address [1] 303441 0
Country [1] 303441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303928 0
Soddo Christian Hospital IRB
Ethics committee address [1] 303928 0
Soddo Christian Hospital Institutional Review Board, PO Box 305, Soddo, Wolaita, Ethiopia
Ethics committee country [1] 303928 0
Ethiopia
Date submitted for ethics approval [1] 303928 0
21/02/2019
Approval date [1] 303928 0
05/03/2019
Ethics approval number [1] 303928 0
SCHIRB 2019.1

Summary
Brief summary
TEFF-AF study will provide crucial epidemiological understanding of the cardiovascular risk profile and Atrial Fibrillation burden in the Ethiopian population. Healthy ambulant adults living in the catchment areas of Soddo Christian Hospital, Ethiopia will be invited to participate in a screening protocol involving; (1) Initial brief medical history of existing medical condition(s) and medication history; (2) Measurements of weight, height and blood pressure with an automated machine; and (3) Single lead ECG recording of 30-60s using the AliveCor Kardia device which will detect suspected AF. It is hypothesized that the cardiovascular risk factor profile of Ethiopians will be a determining factor in the prevalence of AF.
Trial website
Trial related presentations / publications
Public notes
Study data will be collected and managed using REDCap electronic data capture tools hosted at South Australian Health and Medical Research Institute (SAHMRI). REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.

Contacts
Principal investigator
Name 95286 0
Dr Sok-Hui Goh
Address 95286 0
Soddo Christian Hospital, PO Box 305, Soddo, Wolaita, Ethiopia
Country 95286 0
Ethiopia
Phone 95286 0
+2510465511164
Fax 95286 0
Email 95286 0
sokhui@soddo.org
Contact person for public queries
Name 95287 0
Dennis Lau
Address 95287 0
The University of Adelaide, Adelaide SA 5005
Country 95287 0
Australia
Phone 95287 0
+6188313 9000
Fax 95287 0
Email 95287 0
dennis.lau@adelaide.edu.au
Contact person for scientific queries
Name 95288 0
Dennis Lau
Address 95288 0
The University of Adelaide, Adelaide SA 5005
Country 95288 0
Australia
Phone 95288 0
+6188313 9000
Fax 95288 0
Email 95288 0
dennis.lau@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics data safety


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes JMIR Mhealth Uhealth. 2021 May 19;9(5):e24470. doi... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePerformance of a Mobile Single-Lead Electrocardiogram Technology for Atrial Fibrillation Screening in a Semirural African Population: Insights From "The Heart of Ethiopia: Focus on Atrial Fibrillation" (TEFF-AF) Study.2021https://dx.doi.org/10.2196/24470
N.B. These documents automatically identified may not have been verified by the study sponsor.