Trial Review

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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] 305846 0
None
Universal Trial Number (UTN)
U1111-1271-9812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
covid-19 324450 0
Condition category
Condition code
Infection 321937 321937 0 0
Other infectious diseases
Respiratory 321949 321949 0 0
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] 322286 0
Not applicable
Comparator / control treatment
Vaccinated patients admitted as an inpatient who are covid-19 positive
Control group
Active

Outcomes
Primary outcome [1] 329692 0
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] 329692 0
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] 403463 0
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] 403463 0
Day 2 of admission, or as soon as the patient is well enough
Secondary outcome [2] 403464 0
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] 403464 0
Day 2 of admission, or as soon as the patient is well enough
Secondary outcome [3] 403465 0
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] 403465 0
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?
No
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)
SA
Recruitment hospital [1] 21217 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 21218 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 36086 0
5042 - Bedford Park
Recruitment postcode(s) [2] 36087 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310203 0
Hospital
Name [1] 310203 0
Flinders Medical Centre, in kind for staff time
Country [1] 310203 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive
Bedford Park 5042
South Australia
Australia
Country
Australia
Secondary sponsor category [1] 311344 0
None
Name [1] 311344 0
Address [1] 311344 0
Country [1] 311344 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309883 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309883 0
SA Health
PO Box 287
Rundle Mall 5000
Adelaide
South Australia
Australia
Ethics committee country [1] 309883 0
Australia
Date submitted for ethics approval [1] 309883 0
31/01/2022
Approval date [1] 309883 0
Ethics approval number [1] 309883 0

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 115718 0
Dr D-Yin Lin
Address 115718 0
c/o Dept of Anaesthesia, Flinders Medical Centre
Flinders Drive, Bedford Park 5042
SA
Country 115718 0
Australia
Phone 115718 0
+6188204 5511
Fax 115718 0
Email 115718 0
[email protected]
Contact person for public queries
Name 115719 0
Dr D-Yin Lin
Address 115719 0
c/o Dept of Anaesthesia, Flinders Medical Centre
Flinders Drive, Bedford Park 5042
SA
Country 115719 0
Australia
Phone 115719 0
+6188204 5511
Fax 115719 0
Email 115719 0
[email protected]
Contact person for scientific queries
Name 115720 0
Dr D-Yin Lin
Address 115720 0
c/o Dept of Anaesthesia, Flinders Medical Centre
Flinders Drive, Bedford Park 5042
SA
Country 115720 0
Australia
Phone 115720 0
+6188204 5511
Fax 115720 0
Email 115720 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


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.