ANZCTR - Registration

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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

3/05/2023

Date data sharing statement initially provided

22/02/2021

Date results information initially provided

7/07/2022

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

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]

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]

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]

6 months post-study commencement

Secondary outcome [1]

(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]

12 months post-study commencement

Secondary outcome [2]

(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]

12 months post-study commencement

Secondary outcome [3]

(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]

6 months post-study commencement

Secondary outcome [4]

(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]

12 months post-study commencement

Secondary outcome [5]

(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]

12 months post-study commencement

Secondary outcome [6]

(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]

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

Active, not recruiting

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

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]

Charities/Societies/Foundations

Name [1]

Vanguard Grant, The National Heart Foundation of Australia.

Address [1]

The National Heart Foundation of Australia
Sydney NSW: Level 3, 80 William St, Sydney, NSW 2011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, University of Sydney

Ethics committee address [1]

Level 3, Administration Building (F23)
University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/09/2020

Approval date [1]

27/11/2020

Ethics approval number [1]

2020/680

Summary

Brief summary

Patient-led screening for atrial fibrillation (AF) using handheld mobile electrocardiogram (ECG) devices at their homes may help in detecting AF. However, there is no established system to facilitate the diagnosis and management of AF when a suspected case is detected. Therefore, we aim to study whether we can implement an AF screening program using handheld mobile ECG devices integrated with a cardiac centre at Westmead Hospital, New South Wales, that is able to confirm the diagnosis and facilitate appropriate management of new AF.

Participants are given a handheld mobile ECG device and they will receive training in using the device. They will involve in the study for a period of 12 months. Participants randomised to the intervention group will commence monitoring straight away while participants in the control group will wait for 6 months to receive the handheld ECG device. During the waiting period, they see their general practitioners (GPs) for usual care.

Participants record a 30-second daily ECG on weekdays. ECGs will be automatically transmitted to Westmead Cardiology Department and monitored by trained technicians. Participants and their GPs will be notified of ECG abnormality and GPs can access support from cardiologists involved in this research.

The primary outcome at 6-month follow-up (or when AF is diagnosed, whichever occurs first) 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 group compared to the control group.

Trial website

Trial related presentations / publications

Public notes

"Participant Recruitment Information"

Be part of a new research study looking to detect atrial fibrillation (irregular heart rhythm) in the community. The University of Sydney is conducting a study that remotely monitors a person’s heart rhythm.

We are looking for people who will use a small handheld device that connects to their smartphone to monitor their heart rhythm.

The study procedures have been designed to be conducted virtually or by telephone in the context of the COVID-19 pandemic and subsequent waves.

About you: You are 75 years or older and have never been diagnosed with atrial fibrillation (irregular heart rhythm). You are living in Australia.

About us: The University of Sydney’s Westmead Applied Research Centre is a pioneering research centre led by world-class cardiologists, clinicians and researchers.

The study “Mass screening for atrial fibrillation (AF) in the over-75y using handheld devices integrated with a central monitoring service: A pilot study of feasibility and preliminary efficacy (MASS-AF Study)” is led by Professor Clara Chow.

To register your interest:
Email: [email protected]
Telephone: 02 8890 3125 or Mobile phone: 0466 055 962

Contacts

Principal investigator

Name

Prof Clara Chow

Address

Westmead Applied Research Centre,
REN Building, Westmead Hospital,
Darcy Road, Westmead 2145 NSW

Country

Australia

Phone

+61 2 8890 3125

Fax

[email protected]

Contact person for public queries

Name

Dr Kam Cheong Wong

Address

Westmead Applied Research Centre,
REN Building, Westmead Hospital,
Darcy Road, Westmead 2145 NSW

Country

Australia

Phone

+61 2 8890 3125

Fax

[email protected]

Contact person for scientific queries

Name

Dr Tu Nguyen

Address

Westmead Applied Research Centre,
REN Building, Westmead Hospital,
Darcy Road, Westmead 2145 NSW

Country

Australia

Phone

+61 2 8890 3125

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19072	Statistical 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

Source	Title	Year of Publication	DOI
Dimensions AI	Process Evaluation of a Randomised Control Trial of Patient-Led Atrial Fibrillation Screening in Community-Dwelling Older People: A Qualitative Framework Approach	2023	https://doi.org/10.1016/j.hlc.2023.06.417
Dimensions AI	Rapid Access Chest Pain Clinic Response to COVID-19 Pandemic: A Review of Adaptation and Performance	2023	https://doi.org/10.1016/j.hlc.2023.06.418
Dimensions AI	Steering a Patient-Led Community Atrial Fibrillation Screening Trial Through the COVID-19 Pandemic: Synergising Virtual and Face-to-Face Approaches	2023	https://doi.org/10.1016/j.hlc.2023.06.426

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically