Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000635965
Ethics application status
Approved
Date submitted
12/05/2020
Date registered
29/05/2020
Date last updated
29/05/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Open label, prospective study for the Biofourmis Everion armband telemonitoring solution for patients during COVID-19 home isolation within South Western Sydney
Scientific title
Open label, prospective study for the Biofourmis Everion armband telemonitoring solution for patients during COVID-19 home isolation within South West Sydney to assess the feasibility and suitability of the Everion armband device in the telemonitoring of COVID-19 high risk patients under home isolation period
Secondary ID [1] 301279 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
BEAT Biofourmis Everion Armband Telemonitoring
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 positive 317442 0
Condition category
Condition code
Public Health 315533 315533 0 0
Health service research
Infection 315746 315746 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients recently diagnosed with COVID-19 who are currently under home isolation protocol or about to undergo home isolation will be considered as potential participants. Consented participants will be provided with the Everion armband and educated in the utilisation and care of the technology. The education will take approximately 15-20 minutes and be provided by the Triple-I Nurse either in person at the participants home or over video/ telephone call.
Participants will be monitored for changes in temperature, heart rate, respiratory rate, oxygen levels and symptoms of COVID-19 for the length of their isolation period until clinical clearance is granted. Biometric readings and alerts will be monitored by the clinical staff from the Triple I (Hub) who will escalate to the relevant doctor for a consultation and a decision will be made on the participants clinical care as per SWSLHD Procedure for "Follow-up of Positive COVID-19 patients in home isolation".
Intervention code [1] 317572 0
Prevention
Intervention code [2] 317712 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323780 0
To assess the feasibility of the Everion armband device in the telemonitoring of COVID-19 high risk patients under home isolation period using data from the Everion armband device and a study-specific questionnaire
Timepoint [1] 323780 0
After receiving clinical clearance
Primary outcome [2] 323800 0
To assess the suitability of the Everion armband device in the telemonitoring of COVID-19 high risk patients under home isolation period using data from the Everion armband device and a study specific questionnaire
Timepoint [2] 323800 0
After receiving clinical clearance.
Secondary outcome [1] 382934 0
Health care team satisfaction using a study specific questionnaire
Timepoint [1] 382934 0
After the participant has received clinical clearance

Eligibility
Key inclusion criteria
Aged 18 years or above
COVID-19 positive and undergoing/to undergo home isolation protocol
Able to follow and complete instructions and questionnaires
Able to provide own informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk patient in need of hospitalization/in-patient
No consent signed

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Statistical methods / analysis
Patients recently diagnosed with COVID-19 who are currently under isolation protocol or about to undergo isolation will be considered as potential participants.

Fifty (50) consented participants will be provided with the Everion armband and educated in the utilisation and care of the technology. Participants will be monitored for the length of their isolation period until clinical clearance is granted. Biometric readings and alerts will be monitored by the clinical staff at the Triple I (Hub) who will escalate clinical management as per South Western Sydney Local Health District Procedure for “Follow-up of positive Covid-19 patients in home isolation”.

The data collected will be analysed by the clinical team to establish accuracy and efficacy; the clinical team will also complete a questionnaire comparing the experience against normal isolation follow-up protocol. Patients will fill out a questionnaire regarding their experience of using the Everion.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16646 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 16647 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 16648 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 16649 0
Camden Hospital - Camden
Recruitment hospital [5] 16650 0
Fairfield Hospital - Prairiewood
Recruitment hospital [6] 16651 0
Bowral Hospital - Bowral
Recruitment postcode(s) [1] 30242 0
2170 - Liverpool
Recruitment postcode(s) [2] 30243 0
2200 - Bankstown
Recruitment postcode(s) [3] 30244 0
2560 - Campbelltown
Recruitment postcode(s) [4] 30245 0
2570 - Camden
Recruitment postcode(s) [5] 30246 0
2176 - Prairiewood
Recruitment postcode(s) [6] 30247 0
2576 - Bowral

Funding & Sponsors
Funding source category [1] 305715 0
Government body
Name [1] 305715 0
South Western Sydney Local Health District
Country [1] 305715 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Administration Building, Eastern Campus Liverpool Hospital
Corner of Elizabeth and Goulburn Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 306133 0
None
Name [1] 306133 0
Address [1] 306133 0
Country [1] 306133 0
Other collaborator category [1] 281308 0
Other Collaborative groups
Name [1] 281308 0
Ingham Institute for Applied Medical Research
Address [1] 281308 0
1 Campbell Street, Liverpool NSW 2170
Country [1] 281308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305990 0
South Western Sydney Human Research Ethics Committee
Ethics committee address [1] 305990 0
Ethics committee country [1] 305990 0
Australia
Date submitted for ethics approval [1] 305990 0
19/04/2020
Approval date [1] 305990 0
07/05/2020
Ethics approval number [1] 305990 0
2020/ETH00909

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

Contacts
Principal investigator
Name 102334 0
Prof Josephine Chow
Address 102334 0
Clinical Streams Office, Don Everett Building Level 1, Liverpool Hospital
Locked Bag 7103, BC1871, Liverpool BC NSW 1871
Country 102334 0
Australia
Phone 102334 0
+61 2 87383713
Fax 102334 0
Email 102334 0
Josephine.Chow@health.nsw.gov.au
Contact person for public queries
Name 102335 0
Josephine Chow
Address 102335 0
Clinical Streams Office, Don Everett Building Level 1, Liverpool Hospital
Locked Bag 7103, BC1871, Liverpool BC NSW 1871
Country 102335 0
Australia
Phone 102335 0
+61 2 87383713
Fax 102335 0
Email 102335 0
Josephine.Chow@health.nsw.gov.au
Contact person for scientific queries
Name 102336 0
Josephine Chow
Address 102336 0
Clinical Streams Office, Don Everett Building Level 1, Liverpool Hospital
Locked Bag 7103, BC1871, Liverpool BC NSW 1871
Country 102336 0
Australia
Phone 102336 0
+61 2 87383713
Fax 102336 0
Email 102336 0
Josephine.Chow@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified aggregated participant information will be available.


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.