ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620000808943

Ethics application status

Approved

Date submitted

27/07/2020

Date registered

11/08/2020

Date last updated

11/08/2020

Date data sharing statement initially provided

11/08/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

A Patient Perspective Survey on Masking or De-Masking the Medical Staff amid COVID-19 Pandemic

Scientific title

A Patient Perspective Survey on Masking or De-Masking the Medical Staff amid COVID-19 Pandemic

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1256-1499

Trial acronym

nil

Linked study record

nil

Health condition

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

COVID-19

Cross Infection

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a study-specific survey focusing on determining the patient's perceptions of mask-wearing by medical staff and the relationship with the daily consumption of COVID19 information. It takes approximately 1-2 minutes to complete the anonymous written questionnaire survey.
Patients need to complete the survey only once when they are admitted to the hospital, there is no follow up survey for that particular patient. However, if they are readmitted to our hospital during the study period (March to August 2020), they are potentially surveyed again, but this is not patient-specific but time-specific, i.e., admissions during the study period

Intervention code [1]

Not applicable

Comparator / control treatment

chronological comparison between the 1st COVID-19 pandemic wave and the 2nd wave of patient's media consumption surrounding coronavirus and their opinions on mask use by medical staff
We started to collect data from the end of March 2020 and stopped in early May 2020, this period corresponds the 1st wave in Victoria, which was mostly imported COVID cases that peaked during this period.
We restarted to collect data in the beginning of July 2020 and would expect to complete in the end of August 2020, this period corresponds the second wave in Victoria, where there is more community-based COVID transmissions that will peak during this period.

Control group

Historical

Outcomes

Primary outcome [1]

Patient perceptions of mask wearing by medical staff will be assessed using study-specific survey, Patient attitude towards mask wearing by medical staff will be assessed against several timepoints when important policies issued during the course: 1. WHO recommended the public to wear masks in the end of March 2020 2. Victoria recommended to wear masks in public places in early July 2020 3. Victoria announced mandatory mask wearing when going out of homes in the end of July 2020

Timepoint [1]

At time of single cross-sectional survey completed amid COVID-19 pandemic, covering two peak periods from March to August 2020, and including 3 important policy timepoints during the study period, which are: 1. WHO recommended the public to wear masks in the end of March 2020 2. Victoria recommended to wear masks in public places in early July 2020 3. Victoria announced mandatory mask wearing when going out of homes in the end of July 2020

Secondary outcome [1]

Patient's media consumption of COVID19 will be assessed using study-specific survey, The volume of daily information consumption will be checked along the course of COVID pandemic in Victoria

Timepoint [1]

At time of single cross-sectional survey completed amid COVID-19 pandemic, covering two peak periods from March to August 2020.

Eligibility

Key inclusion criteria

Patients admitted to Maroondah and Box Hill Hospital of Eastern Health for surgical or medical reasons

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Younger than 16 years
- Intellectual disability or dementia
- Language barrier, visual or hearing impairment
- Suspected or confirmed COVID-19

Study design

Purpose

Psychosocial

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Descriptive statistics will be used:
1. Percentage of patients in each category will be compared between the first wave/period (end of March to early May 2020) and the second wave/period (July to August 2020)
2. Qualitative data from patients' comments will be summarized and quantified as appropriate

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

23/03/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

600

Accrual to date

500

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Maroondah Hospital - Ringwood East

Recruitment hospital [2]

Box Hill Hospital - Box Hill

Recruitment postcode(s) [1]

3135 - Ringwood East

Recruitment postcode(s) [2]

3128 - Box Hill

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Maroondah Hospital

Address [1]

1-15 Davey Drive East Ringwood VIC 3135

Country [1]

Australia

Primary sponsor type

Hospital

Name

Maroondah Hospital

Address

1-15 Davey Drive
East Ringwood
VIC 3135

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Box Hill Hospital

Address [1]

8 Arnold Street Box Hill VIC 3128

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Research & Ethics Committee

Ethics committee address [1]

Level 2
5 Arnold Street
Box Hill 
VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2020

Approval date [1]

04/06/2020

Ethics approval number [1]

LR20-032

Summary

Brief summary

With the emergence of the novel COVID-19 virus, medical staff are continuing to expose and put themselves at risk in their day to day work. This virus is known to spread through primarily droplet exposure. Frontline medical staff are at highest risk in being exposed to droplets from the potential asymptomatic or mild COVID-19 individuals. A simple, but effective, means to reduce droplet spread is the use of face masks. However, wearing face masks outside operating theatres is not routine practice in Australian Hospitals, as such, there is concern that it could cause fear and anxiety in already stressed patients. Such concern has caused a dilemma among some medical staff with regards to masking or de-masking while at work. In order to find out whether this concern is real, i.e., how patients feel about the change in practice by medical staff wearing face masks, we designed this written questionnaire survey to examine patients’ attitudes towards masking the medical staff at work during COVID-19 pandemic.

Trial website

nil

Trial related presentations / publications

nil

Public notes

This project was pre-approved in mid-March 2020 by our local Ethics Committee (before we commenced the study) via emailing, in which it stated: "You can regard this as approval in anticipation of a low risk application. This expedited approval process acknowledges the need to be adaptable to the challenges COVID- 19 presents as well as the opportunities to learn from this experience". 
We submitted our formal low risk ethics application with the pre-approval email in May 2020, that's why our final Ethics approval date was in June 2020.
Pre-approval email is available upon request

Contacts

Principal investigator

Name

Dr Aihua Wu

Address

Department of Anaesthesia Maroondah Hospital 1-15 Davey Drive East Ringwood VIC 3135

Country

Australia

Phone

+61398713448

Fax

[email protected]

Contact person for public queries

Name

Aihua Wu

Address

Department of Anaesthesia Maroondah Hospital 1-15 Davey Drive East Ringwood VIC 3135

Country

Australia

Phone

+61398713448

Fax

[email protected]

Contact person for scientific queries

Name

Aihua Wu

Address

Department of Anaesthesia Maroondah Hospital 1-15 Davey Drive East Ringwood VIC 3135

Country

Australia

Phone

+61398713448

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Anyone who wishes to access the data.

Conditions for requesting access:
• -

What individual participant data might be shared?

• All of the individual participant data collected during the trial, which are already non-identifiable.

What types of analyses could be done with individual participant data?

• Any purpose.

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication. No end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Data are available indefinitely by emailing the principal investigator Dr Aihua Wu at [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8590	Ethical approval			[email protected]		Study-related document.pdf
8591	Other			[email protected]	Survey questionnaire	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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically