Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001374954
Ethics application status
Approved
Date submitted
14/09/2020
Date registered
22/12/2020
Date last updated
22/12/2020
Date data sharing statement initially provided
22/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of smart watch technology to improve the management of patients presenting with fast irregular heart rates in the Emergency department - a pilot study
Scientific title
Use of single lead ECG to assist cardioversion in atrial fibrillation in the Emergency department - a pilot study
Secondary ID [1] 302861 0
Nil known
Universal Trial Number (UTN)
U1111-1255-0346
Trial acronym
SELECTED
Linked study record
Not Linked

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 318184 0
Condition category
Condition code
Cardiovascular 316197 316197 0 0
Other cardiovascular diseases
Emergency medicine 317789 317789 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recruit 50 participants (Intervention group) with atrial fibrillation (AF) where the onset is less than 24 hours before presentation to emergency department (ED), who are able to have delayed cardioversion in addition to standard medical care. These participants will receive at home monitoring of their heart rhythm with the Alivecor mobile single lead electrocardiogram (ECG) device. The participants will be required to record and transmit each single lead ECG every 6 hours for 48 hours. Participants will receive a text message and/ or phone call if a ECG recording is missing.
If normal rhythm is restored spontaneously within 48 hours, they will not be required to return to ED. The minority (31%) of participants with ongoing AF will be instructed to return to ED for a scheduled cardioversion.
In both scenarios, after the initial 48 hour period, the patient will be asked to record and send ECGs twice weekly, which will be reviewed by the research team. Four weeks later, they will have a follow-up cardiology appointment, either in person or via telemedicine.
Intervention code [1] 319143 0
Diagnosis / Prognosis
Intervention code [2] 319144 0
Early detection / Screening
Comparator / control treatment
Patients that have previously presented to ED with AF and were treated with cardioversion during the 12 month period prior to study commencement will be aged matched to the intervention group.
Control group
Historical

Outcomes
Primary outcome [1] 325114 0
Total number of emergency department time spent per visit for enrolled participants compared with historical age matched controls.
Timepoint [1] 325114 0
Four weeks after initial presentation to hospital with AF as assessed by hospital records.
Secondary outcome [1] 386893 0
Results of readings during remote monitoring period and need for repeat ED review. Results of readings are classified as follows:
o Reversion to sinus rhythm. ED review not required
o Possible AF, requiring ED review
o Uninterpretable, requiring ED review
o Unclassified, requiring ED review
The ECG's will be reviewed manually by the study physician.
Timepoint [1] 386893 0
First 48 hours
Secondary outcome [2] 386894 0
Proportion of participants subsequently requiring ED cardioversion as assessed by hospital records.
Timepoint [2] 386894 0
First 4 weeks
Secondary outcome [3] 386895 0
Presence of AF at 4-week cardiology outpatient review, assessed as the presence of AF on ECG.
Timepoint [3] 386895 0
First 4 weeks

Eligibility
Key inclusion criteria
50 patients with AF onset less than 24 hours presenting to ED who are able to have delayed cardioversion.
• Age: 18 years or greater
• Residing within the Eastern Health catchment during the initial intervention period (48 hours from time of ED presentation)
• Haemodynamically stable
• Recent onset AF : <24 hours of symptomatic first episode or recurrent AF
• Have compatible smart phone or tablet to use the Alivecor device
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• AF onset time unclear.
• History of long-standing persistent AF (continuous AF for more than 1 year)
• Patients with haemodynamically unstable AF who require emergent cardioversion
• Have a cardiac pacemaker or implantable cardioverter defribrillator or other implanted electronic device
• Unable to provide informed consent

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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be undertaken on an intention-to-treat analysis.
Descriptive statistics (means, standard deviation, medians and interquartile ranges will be used to summarise the data. Relationships between variables will be examined using Chi-square tests for categorical data and independent t test or Mann-Whitney rank sum tests for continuous data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/02/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17524 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 17525 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [3] 17526 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 31254 0
3128 - Box Hill
Recruitment postcode(s) [2] 31255 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [3] 31256 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 306166 0
Charities/Societies/Foundations
Name [1] 306166 0
Freemason Foundation
Country [1] 306166 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold St, Box Hill, Victoria, 3218
Country
Australia
Secondary sponsor category [1] 307274 0
None
Name [1] 307274 0
Address [1] 307274 0
Country [1] 307274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306379 0
Eastern Health
Ethics committee address [1] 306379 0
5 Arnold St, Box Hill, Victoria, 3128
Ethics committee country [1] 306379 0
Australia
Date submitted for ethics approval [1] 306379 0
22/07/2020
Approval date [1] 306379 0
11/09/2020
Ethics approval number [1] 306379 0

Summary
Brief summary
The use of smart watch technology to improve the management of patients presenting with fast irregular heart rates (AF) in the Emergency department (ED). Participants will be given a Alivecor single lead ECG device to monitor their heart rhythm every 6 hours for the next 48 hours. If after 48 hours the heart rhythm has reverted to normal no further visits to ED are required.
If they remain in AF they will return to the ED for an elective cardioversion to restore a normal heart rhythm.
The aim of the study to the improve the management of these patients in ED and reduce the number of visits to ED.
Trial website
Nil Known
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 103678 0
Dr Paul Buntine
Address 103678 0
Box Hill Hospital, Emergency department, 8 Arnold St, Box Hill, Victoria, 3128
Country 103678 0
Australia
Phone 103678 0
+61 03 9095 2441
Fax 103678 0
Email 103678 0
[email protected]
Contact person for public queries
Name 103679 0
Dr Louise Roberts
Address 103679 0
Box Hill Hospital, Cardiology Department, 8 Arnold St, Box Hill, Victoria, 3128
Country 103679 0
Australia
Phone 103679 0
+61 03 9095 2441
Fax 103679 0
Email 103679 0
[email protected]
Contact person for scientific queries
Name 103680 0
Dr Paul Buntine
Address 103680 0
Box Hill Hospital, Emergency Department, 8 Arnold St, Box Hill, Victoria, 3128
Country 103680 0
Australia
Phone 103680 0
+61 03 9095 2441
Fax 103680 0
Email 103680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not Eastern Health's policy to share data.


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
No additional documents have been identified.