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Trial registered on ANZCTR


Registration number
ACTRN12621000184875
Ethics application status
Approved
Date submitted
6/11/2020
Date registered
22/02/2021
Date last updated
27/10/2024
Date data sharing statement initially provided
22/02/2021
Date results provided
27/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening for atrial fibrillation in the over-75s with handheld ECG devices
Scientific title
Mass screening for atrial fibrillation in the over-75s using handheld devices integrated with a central monitoring service: A pilot study of feasibility and preliminary efficacy
Secondary ID [1] 302704 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 319618 0
Condition category
Condition code
Cardiovascular 317562 317562 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will acquire a single-lead electrocardiogram (ECG) trace by placing minimum one finger of each hand on each small touchpad (3cm x 3cm) of the device for 30 seconds once daily on weekdays (12 months for intervention group and 6 months for waitlist group). The device is connected to their mobile phone wirelessly and an ECG trace will appear on the mobile phone confirming that the participant has recorded their ECG. Participants confirm their identity and ECG will be transmitted to a central monitoring system automatically.

Participants will receive printed instructions on “how to download the Kardia app into their mobile phone” and “how to set up an account to use the app” when they receive the handheld ECG device. We will also send participants a mobile text message with a weblink that will take them to a training video produced by the device manufacturer (AliveCor Kardia). Participants can click on the weblink to watch the short video. In addition, study personnel will call each participant to support and help the participant overcome any technical difficulties and test run the device to make sure all participants can acquire an ECG and answer any questions participants may have. The above training and interaction will take approximately 30 – 60 minutes per participant. The intervention program will commence upon successful transmission of first ECG from each participant.

Participants will receive daily notification to do their ECG. If no ECG is received for three consecutive days, our central review process will identify this, and a study personnel will then contact the participants by phone, text message or email.

At 6-month follow up or upon diagnosis of atrial fibrillation (whichever occurs first), participants will be invited to participate in a survey and one-to-one interview to assess their satisfaction and feedback about their experience in the program.
Intervention code [1] 318987 0
Early detection / Screening
Comparator / control treatment
Participants visit their general practitioner as per their individual needs. Their general practitioner will perform physical examinations, obtain vital signs, order investigations and may refer participants to specialist care as deemed necessary. Participants in the control arm are not given a handheld ECG device during 6-month waiting period.
Control group
Active

Outcomes
Primary outcome [1] 325608 0
The primary outcome is the proportion of participants’ reporting being very satisfied/satisfied that their heart rhythm was being monitored in the past 6 months in the intervention arm compared to the control arm.

The primary outcome was assessed at 6 months post-study commencement. Participants are invited to answer a study-specific survey question: ‘How satisfied are you that your heart rhythm was being monitored in the past 6 months?’ (1 equals Very satisfied, 2 equals Satisfied, 3 equals Somewhat satisfied, 4 equals Not satisfied.)
Timepoint [1] 325608 0
6 months post-study commencement
Secondary outcome [1] 388537 0
(1) The feasibility of implementing the atrial fibrillation (AF) screening program using AliveCor Kardia device in community-dwelling people aged 75 or older, including the following:

Recruitment rate: (number of sites x randomized patients per site) divided by the number of months of recruitment time, as assessed via the “study enrolment log”.

Frequency of daily transmission of ECGs to the central monitor: Number of ECG transmitted to central monitor per participant by week and month, as assessed via the “centralised ECG monitoring portal”.

Proportion of “unreadable ECG” due to poor ECG tracing: number of ECGs that could not be interpreted by researcher due to poor quality of ECG tracing divided by the total ECGs transmitted to the central monitor during the study time, as assessed via the “centralised ECG monitoring portal”.
Timepoint [1] 388537 0
12 months post-study commencement
Secondary outcome [2] 388538 0
(2) The acceptability of the screening program (based on participants’ overall rating scores on a usability questionnaire).
We established a usability questionnaire specific to this study and also adapted and modified questions from the following references: International Organization for Standardization. ISO 9241-11:2018 Part 11: Usability: Definitions and concepts. Geneva, Switzerland, 2018 and Halcox, J.P.J., et al., Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation, 2017. 136(19): p. 1784-1794.
Timepoint [2] 388538 0
12 months post-study commencement
Secondary outcome [3] 388539 0
(3) The incidence of a new diagnosis of AF (detected by the automatic interpretation the algorithm of AliveCor Kardia and confirmed by the clinical researchers reviewing the AliveCor ECG readings) after 6 months among those randomised to immediate monitoring with AliveCor Kardia device compared to those in the control group.

Participants in the control group will be asked whether they have been diagnosed with atrial fibrillation (irregular heart rhythm) or they have been prescribed new medication to thin the blood during the waiting period. We will attempt to verify the diagnosis utilising supporting medical data that the participant can provide e.g. ECG report and health records. The diagnosis will be recorded in case report form.
Timepoint [3] 388539 0
6 months post-study commencement
Secondary outcome [4] 388540 0
(4) The impact of frailty on the feasibility of implementing the AF screening program using AliveCor Kardia device in community-dwelling older people.

Frailty is defined by the FRAIL scale, which includes 5 components and has been widely used in previous studies (Reference: Kojima G. Frailty Defined by FRAIL Scale as a Predictor of Mortality: A Systematic Review and Meta-analysis. J Am Med Dir Assoc 2018; 19(6): 480-3):

Fatigue: “How much of the time during the past 4 weeks did you feel tired?” 1 equals All of the time, 2 equals Most of the time, 3 equals Some of the time, 4 equals A little of the time, 5 equals None of the time. Responses of “1” or “2” are scored as 1 and all others as 0.

Resistance: “By yourself and not using aids, do you have any difficulty walking up 10 steps without resting?” 1 equals Yes, 0 equals No.

Ambulation: By yourself and not using aids, do you have any difficulty walking 1km?” 1 equals Yes, 0 equals No.

Chronic health conditions:
- Hypertension
- Coronary heart disease (angina, myocardial infarction, Percutaneous coronary intervention, coronary artery bypass surgery)
- Peripheral artery disease
- Aortic atherosclerosis
- Stroke
- Heart failure
- Diabetes
- Chronic obstructive pulmonary disease
- Asthma
- Arthritis
- Kidney disease
- Other

Illnesses: from the list of chronic health conditions above, nil to four conditions equals 0, and 5 or more conditions equals 1.

Loss of weight: ask the participants their current weight and their weight in the previous year. If loss of weight by 5% or more, score as 1; if loss of weight by less than 5%, score as 0.
If they do not remember their weight, ask “Have you recently lost weight such that your clothing has become looser?”, if Yes, score as 1.

Participants with a total score of 3 or greater will be identified as frail.

We will compare the following outcomes between frail and non-frail participants:
- The proportion of participants reporting very satisfied/satisfied about their heart rhythm monitoring in the past 6 month
- Frequency of daily transmission of ECGs to the central monitor
- The proportion of “unreadable ECG”
Logistic regression and linear regression will also be performed to examine the impact of frailty on these outcomes.
Timepoint [4] 388540 0
12 months post-study commencement
Secondary outcome [5] 388541 0
(5) We will prospectively and alongside collect the actual operational costs of delivering the project in a “costs spreadsheet”. This will be verified using invoices and receipts. Costs include those associated with equipment and personnel to train patients and monitor ECGs, then compare the actual costs of the screening program within this trial to literature that reported costs associated with screen-detected AF in older population.
Timepoint [5] 388541 0
12 months post-study commencement
Secondary outcome [6] 388542 0
(6) Qualitative evaluation of the barriers and enablers to implement the program (from the views of the participants and their general practitioners (GPs) who have facilitated recruitment and/or management of patients). Three months post-enrolment of patients, GP will be invited to attend a one-to-one semi-structured interview. The interviewer will explore GPs’ broad general views about atrial fibrillation screening and use of mobile health devices in clinical practice and then ask specific questions related to barriers and enablers of the screening program. The interview will take approximately 20-30 minutes. A minimum of eight GP interviews will be conducted. The interview approach is informed by the critical realism framework (reference: Bhaskar, R. (2011). Reclaiming reality: A critical introduction to contemporary philosophy. London: Routledge).

After participants have used AliveCor Kardia ECG for a minimum of 3 months, we will invite participants to attend a one-to-one semi-structured interview to gather their feedback and explore their experience in the study. The interview will take approximately 20-30 minutes. A minimum of 8-10 participant interviews will be conducted.
Timepoint [6] 388542 0
3 months post-study commencement.

Eligibility
Key inclusion criteria
1) Community-dwelling people aged 75 or older
2) Have a smartphone that is able to operate AliveCor Kardia system
3) Be able to understand instructions in English
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Having documented diagnosis of AF
2) Having an implantable pacemaker or defibrillator, or both
3) Dementia
4) Inability to provide informed consent
5) Medical illness with anticipated life expectancy < 3 months

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will not be blinded i.e. allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed electronically via REDCap.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size computations:
In calculating the sample size required to evaluate the primary clinical outcome of AF detection rate, we set an AF detection rate of 10% in the intervention group and 1% in the control group with reference to a recent study. At 80% power, 2-sided test, and alpha 0.05, we estimated that a sample of 200 participants will be needed to detect a significant difference in AF detection between the intervention and control group. Therefore, a total of 200 participants will be recruited for this trial.

Statistical Analysis:
All analyses of study outcomes will be conducted according to the principle of intention-to-treat. Continuous variables will be presented as mean (standard deviation) or median (interquartile range), and categorical variables as frequency and percentage. Comparisons between groups (intervention and control) will be assessed using Chi-square test (or Fisher's exact test) for categorical variables and Student’s t-test or Mann-Whitney test for continuous variables as appropriate. Two-tailed P values smaller than 0.05 will be considered statistically significant.

The agreement between ECG device automatic algorithm and clinician interpretation will be evaluated by Kappa statistics. Sub-group analyses will be performed by age, gender, and location. Subgroup analysis by frailty will be performed to examine the potential impact of frailty on outcomes, feasibility, and acceptability of the program. The actual operational costs of delivering the project will be recorded and verified using invoices and receipts including the costs of personnel involved in interpreting ECGs which will be computed based on their hourly wage and the time they spent in their roles in this program. The resultant costs will be compared to costs reported in the literature of costs associated with detection of AF in a similar older population. Missing data will be identified, and its cause will be described. Sensitivity analysis will be performed to examine robustness of the findings.

Qualitative evaluation will be reported according to the “consolidated criteria for reporting qualitative research (COREQ) guidelines. Interviews with patients and GPs will be thematically analysed using an inductive approach. Themes will be interpreted through the critical realism lens and compared with the literature. We will triangulate the quantitative and qualitative findings from patient participants and GPs to acquire in-depth understanding on the barriers and enablers to implement the screening program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2021
Actual
25/05/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
30/06/2022
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307138 0
Charities/Societies/Foundations
Name [1] 307138 0
Vanguard Grant, The National Heart Foundation of Australia.
Country [1] 307138 0
Australia
Primary sponsor type
University
Name
Westmead Applied Research Centre, University of Sydney
Address
REN Building, Westmead Hospital,
Darcy Road, 2145 Westmead, NSW, Australia.
Country
Australia
Secondary sponsor category [1] 307723 0
None
Name [1] 307723 0
Address [1] 307723 0
Country [1] 307723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307250 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 307250 0
Ethics committee country [1] 307250 0
Australia
Date submitted for ethics approval [1] 307250 0
11/09/2020
Approval date [1] 307250 0
27/11/2020
Ethics approval number [1] 307250 0
2020/680

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106566 0
Prof Clara Chow
Address 106566 0
Westmead Applied Research Centre,
REN Building, Westmead Hospital,
Darcy Road, Westmead 2145 NSW
Country 106566 0
Australia
Phone 106566 0
+61 2 8890 3125
Fax 106566 0
Email 106566 0
clara.chow@sydney.edu.au
Contact person for public queries
Name 106567 0
Kam Cheong Wong
Address 106567 0
Westmead Applied Research Centre,
REN Building, Westmead Hospital,
Darcy Road, Westmead 2145 NSW
Country 106567 0
Australia
Phone 106567 0
+61 2 8890 3125
Fax 106567 0
Email 106567 0
kam.wong@sydney.edu.au
Contact person for scientific queries
Name 106568 0
Tu Nguyen
Address 106568 0
Westmead Applied Research Centre,
REN Building, Westmead Hospital,
Darcy Road, Westmead 2145 NSW
Country 106568 0
Australia
Phone 106568 0
+61 2 8890 3125
Fax 106568 0
Email 106568 0
n.nguyen@sydney.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19072Statistical analysis plan    380877-(Uploaded-28-04-2023-16-19-30)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIProcess Evaluation of a Randomised Control Trial of Patient-Led Atrial Fibrillation Screening in Community-Dwelling Older People: A Qualitative Framework Approach2023https://doi.org/10.1016/j.hlc.2023.06.417
Dimensions AISteering a Patient-Led Community Atrial Fibrillation Screening Trial Through the COVID-19 Pandemic: Synergising Virtual and Face-to-Face Approaches2023https://doi.org/10.1016/j.hlc.2023.06.426
N.B. These documents automatically identified may not have been verified by the study sponsor.