ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12621001638820p

Ethics application status

Submitted, not yet approved

Date submitted

25/11/2021

Date registered

30/11/2021

Date last updated

3/02/2022

Date data sharing statement initially provided

30/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Vaccine choices, regret and patient characteristics in covid-19 positive patients admitted as an inpatient: a prospective multicentre trial

Scientific title

Vaccine choices, regret and patient characteristics in covid-19 positive patients admitted as an inpatient: a prospective multicentre trial

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1271-9812

Trial acronym

Linked study record

Health condition

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

covid-19

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is an electronic based survey that aims to assess the patient demographics of vaccinated and unvaccinated participants in two South Australian hospitals, the Royal Adelaide Hospital and Flinders Medical Centre. We shall also examine the reasoning behind the choice to remain unvaccinated for the covid-19 virus in this current pandemic, and the incidence of regret for their choice in both the unvaccinated and vaccinated covid-19 positive population.
this survey takes approximately 5-10 minutes to complete. It is conducted once.
No other tasks or activities will be involved for this study.

Intervention code [1]

Not applicable

Comparator / control treatment

Vaccinated patients admitted as an inpatient who are covid-19 positive

Control group

Active

Outcomes

Primary outcome [1]

Incidence of regret in the unvaccinated population who are admitted as an inpatient in either the Royal Adelaide Hospital or Flinders Medical Centre as a covid-19 positive patient. A survey is used, in an electronic format. If no device is available to the participant, it shall be conducted via the intercom or telephone with a study investigator.. This is a questionnaire designed specifically for this study.

Timepoint [1]

Day 2 of admission. If the patient is too sick to complete a survey, they shall be reviewed daily to see when their status is compatible with being able to complete this electronic survey.

Secondary outcome [1]

Patient demographics

A survey is used, in an electronic format. If no device is available to the participant, it shall be conducted via the intercom or telephone with a study investigator.. This is a questionnaire designed specifically for this study.

Timepoint [1]

Day 2 of admission, or as soon as the patient is well enough

Secondary outcome [2]

Patient general health rated using the EQ-VAS PROM

A survey is used, in an electronic format. If no device is available to the participant, it shall be conducted via the intercom or telephone with a study investigator.. This is a questionnaire designed specifically for this study.

Timepoint [2]

Day 2 of admission, or as soon as the patient is well enough

Secondary outcome [3]

Incidence of regret in the covid-19 positive vaccinated population

A survey is used, in an electronic format. If no device is available to the participant, it shall be conducted via the intercom or telephone with a study investigator.. This is a questionnaire designed specifically for this study.

Timepoint [3]

Day 2 of admission, or as soon as the patient is well enough

Eligibility

Key inclusion criteria

Unvaccinated or vaccinated patients (two-arm split based on this)
Aged over 18 years
Confirmed SARS covid-19 infection
Admission to an inpatient facility (Royal Adelaide Hospital or Flinders Medical Centre)
Able to give first party consent
Sufficient use of English to answer survey

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Insufficient use of English
Unable to give first party consent
Declined to participate
Death prior to enrolment
Home stay for duration of covid-19 infection
Sedation, or moderate to high dose benzodiazepines or opioid based medication in the last 48 hours
Age under 18 years

Study design

Purpose

Psychosocial

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

A priori power calculation was carried out using PASS 14 Power Analysis and Sample Size Software (Kaysville, Utah, USA) based on an informal pilot study. These showed a conservative estimate of regret in unvaccinated particpants to be 40%, with a SD of 4 points. An estimate of regret in vaccinated participants based on experienced side effects is 20%. We shall utilise a 5 point Likert scale, over 5 targeted questions. A two-tailed independent-samples t-test for the difference between the two unpaired means with an alpha-error of 0.05, and power of 0.95 showed that 125 patients in each arm were required to detect a difference. n=250

We expect a large percentage of patients to decline to participate, due to the electronic survey nature of this study and the confronting psychology of the primary hypothesis. A conservative enrolment rate of 1 in 2 is estimated.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2022

Actual

Date of last participant enrolment

Anticipated

1/12/2023

Actual

Date of last data collection

Anticipated

1/01/2024

Actual

Sample size

Target

250

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre, in kind for staff time

Address [1]

Flinders Drive
Bedford Park 5042
South Australia
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

Flinders Drive
Bedford Park 5042
South Australia
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

SA Health
PO Box 287
Rundle Mall 5000
Adelaide
South Australia
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/01/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Patient presents/referred to hospital, unvaccinated/vaccinated status is flagged
SARS covid-19 infection is confirmed using standardised testing
Patient is admitted as an inpatient in the RAH/FMC
Approached for inclusion and participation by Dr Lin, on day 3 or whenever well enough.
Inclusion and survey are completed either electronically or via a telephone system built into isolation bay. No face-to-face contact, no prolongation of in-person contact. No use of PPE or risk of additional exposure to staff. 

Microsoft Forms platform survey allowing for electronic signature for written informed consent, or if no electronic device available/other technical difficulty- patient gives verbal consent for the study investigator to electronically sign on their behalf. 
Survey is completed in same manner; electronic or via handset system built into isolation bay.
Survey is conducted during inpatient admission on day 2 or whenever the patient can communicate adequately  and is medically stable enough to complete a research survey. Study investigators will review patient for suitability from Day 2 of admission, on a daily basis.
No long term follow-up. One time point for data collection.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr D-Yin Lin

Address

c/o Dept of Anaesthesia, Flinders Medical Centre
Flinders Drive, Bedford Park 5042
SA

Country

Australia

Phone

+6188204 5511

Fax

indysama@gmail.com

Contact person for public queries

Name

D-Yin Lin

Address

c/o Dept of Anaesthesia, Flinders Medical Centre
Flinders Drive, Bedford Park 5042
SA

Country

Australia

Phone

+6188204 5511

Fax

indysama@gmail.com

Contact person for scientific queries

Name

D-Yin Lin

Address

c/o Dept of Anaesthesia, Flinders Medical Centre
Flinders Drive, Bedford Park 5042
SA

Country

Australia

Phone

+6188204 5511

Fax

indysama@gmail.com

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?

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically