Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000605796
Ethics application status
Approved
Date submitted
14/04/2022
Date registered
22/04/2022
Date last updated
22/04/2022
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 2, community group
Scientific title
Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 2, community group
Secondary ID [1] 306943 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 infection 326055 0
Condition category
Condition code
Public Health 323360 323360 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has four intervention arms to be delivered across four context areas related to COVID-19 health. The four arms include:
1. General Practitioner 'talking head' visual stimulus delivered health message
2. Animated General Practitioner visual stimulus delivered health message
3. Politician visual stimulus delivered health message
4. Written delivery of health message (control)


Each participant will be exposed to each of the four intervention arms (control written provision of health message, General Practitioner 'talking head', General Practitioner 'animation', Politician delivered message), across four different messaging contexts. These contexts are:
1. Getting your booster vaccine
2. Wearing a mask outdoors when you can’t physically distance
3. Staying at home when you have a new cough symptom
4. Using QR check in codes when required

Provision of these intervention combinations across these different contexts is enabled through our "helix", counterbalanced randomised trial design. A Latin square approach has been used to order the exposure of participants to each intervention level combination to eliminate study level order effects.

Each intervention will be delivered as a pre-recorded video. Each video will be of approximately 1-2minutes duration. Each participant will be exposed to all levels of the intervention, with each intervention level being presented in a different context area as per a counterbalanced, 'helix' trial approach (https://doi.org/10.1186/s13012-019-0896-0).
It is anticipated that these videos will be observed over an approximate 15minute period. Participants will observe the videos either in their own home.
Progression of the participant through each of the intervention/context combinations will be monitored via the online data collection platform (Qualtrics). Qualtrics enables of all responses including partial completions, and allows tracking and recording of in-complete survey entries.
Intervention code [1] 323385 0
Behaviour
Comparator / control treatment
The comparators in this study are the different levels of the interventions.
We will be comparing:
1. General Practitioner 'talking head' visual stimulus delivered health message versus Animated General Practitioner visual stimulus delivered health message
2. Politician visual stimulus delivered health message versus General Practitioner 'talking head' visual stimulus delivered health message
3. Written delivery of health message (control) versus all other intervention types (General Practitioner 'talking head', General Practitioner Animation and Politician delivered health message).

The written material will be imbedded within the survey being approximately 1/4 of a page that will take approximately 5-10mins to read. Comparisons are not being made between context areas as a part of the primary analysis, however, we will investigate interaction effects of the different intervention comparisons across the different context areas so that we can understand whether certain interventions work better in certain contexts.
Control group
Active

Outcomes
Primary outcome [1] 331097 0
Stated intention to undertake a context specific behaviour with responses scaled using a 5 point Likert scale ('much less inclined', 'less inclined', 'about the same', 'more inclined' and 'much more inclined').
The specific questions for each context are:
1.Now that you have watched the video (or read the material in the case of the control no video group), please indicate if it has made you feel more or less inclined to have a further dose of the COVID-19 vaccine (when you become eligible to receive it). This includes a 4th dose if you have already had 3 doses.
2. Has viewing this material (or reading this material in the case of the control no video group) made you feel more or less inclined to wear a mask outside when you are unable to socially distance?
3. Has viewing this material (or reading this material in the case of the control no video group) made you feel more or less inclined to spend time with people you do not live with if you were to develop a cough (but that was the only issue)?
4. Has watching this material (or reading this material in the case of the control no video group) made you feel more or less inclined to use QR code check-ins every time you visit a venue if there were to be a future pandemic like the COVID-19 pandemic?
Timepoint [1] 331097 0
Immediately following viewing the intervention
Primary outcome [2] 331098 0
Stated intention to encourage family or friends to undertake a context specific behaviour scaled using a 5 point Likert scale ('extremely unlikely', 'unlikely', 'neutral', 'likely', 'extremely likely').
The specific questions for each context are:
1. If you had a family member or friend who was unsure about having a COVID-19 vaccine booster (3rd dose), how likely would you be to encourage them to get the vaccine?
2. If you had a family member or friend who was unsure about whether they should wear a mask outside if they are unable to socially distance, how likely would you be to encourage them to wear one?
3. If you had a family member or friend who was unsure about spending time with people they do not live with if they developed a cough (but that was the only issue), how likely would you be to encourage them to stay away from other people while they had a cough?
4.If you had a family member or friend who was unsure about using QR code check-ins every time they visited a venue in a future pandemic, how likely would you be to encourage them to use QR code check-ins?
Timepoint [2] 331098 0
Immediately following viewing the intervention.
Secondary outcome [1] 408733 0
Stated feelings of inclusion and representation in the developed video for each context area and how this correlates with level of agreement of the message in the video. Responses scaled using a 5 point Likert scale ('strongly disagree', 'disagree', neither agree nor disagree', 'agree', 'strongly agree'). The specific questions measuring this include:
1. We would like to further understand how well represented you felt in this video. Please indicate how much you agree to the following statement: I felt strongly represented in this video.
2. We are interested in understanding in how much feeling like you are strongly represented in a health message video makes you more likely to agree with the message in the video.
Please indicate how much you agree with the following statement: I am more inclined to agree with the message in a health video if I feel strongly represented in it.
Timepoint [1] 408733 0
Question 1: Immediately following viewing the intervention involving a video.
Question 2: At the end of all interventions delivered (end of survey).

Eligibility
Key inclusion criteria
1. Must be at least 18 years of age or older
2. Reside in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Anyone under the age of 18 years
2. Anyone not living in Australia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Qualtrics data collection platform has an inbuilt randomisation function. Therefore, random allocation will be fully concealed from participants and investigators involved in recruitment and data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In built random allocation sequence within Qualtrics data collection platform.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This design will use a "helix" counterbalanced design including 4 intervention arms across 4 different context areas related to COVID-19 health. The ordering of presentation of intervention combinations to participants will follow a Latin square pattern to eliminate study level order effects.
For more information on helix counterbalanced designs please refer to:
Sarkies MN, Skinner EH, Bowles KA, Morris ME, Williams C, O’Brien L, Bardoel A, Martin J, Holland AE, Carey L, White J. A novel counterbalanced implementation study design: methodological description and application to implementation research. Implementation Science. 2019 Dec;14:45.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analyses will be used treating the intervention levels as fixed factors, participants as random factors. Context will be ignored when investigating intervention main effects as it will be balanced across the different intervention levels. Interaction effects will be investigated to explore impacts of intervention combinations (simple effects), while also exploring interactions of main effects and simple effects across context areas.
Through our analysis we aim to:
1. Compare animated General Practitioner delivered health messages related to COVID-19 to General Practitioner 'talking head' delivered health messages related to COVID-19 (investigating how the message should be delivered).
2. Compare General Practitioner ('talking head') delivered health messages related to COVID-19 to Politician delivered health messages (investigating the effect of 'who' is delivering the message).
3. Compare written (control) approach to:
i) Animated General Practitioner delivered health messages related to COVID-19,
ii) General Practitioner 'talking head' delivered health messages related to COVID-19 iii)Politician delivered health messages related to COVID-19

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311262 0
Government body
Name [1] 311262 0
Australian Government Department of Health (Medical Research Future Fund-Communication Strategies and Approaches During Outbreaks)
Country [1] 311262 0
Australia
Primary sponsor type
Individual
Name
Terry Haines
Address
Monash University
School of Primary and Allied Health Care
Level 3, Building G Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 312619 0
None
Name [1] 312619 0
Address [1] 312619 0
Country [1] 312619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310774 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310774 0
Ethics committee country [1] 310774 0
Australia
Date submitted for ethics approval [1] 310774 0
31/03/2022
Approval date [1] 310774 0
08/04/2022
Ethics approval number [1] 310774 0
30698

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

Contacts
Principal investigator
Name 118814 0
Prof Terry Haines
Address 118814 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118814 0
Australia
Phone 118814 0
+61 433596526
Fax 118814 0
Email 118814 0
[email protected]
Contact person for public queries
Name 118815 0
Terry Haines
Address 118815 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118815 0
Australia
Phone 118815 0
+61 433596526
Fax 118815 0
Email 118815 0
[email protected]
Contact person for scientific queries
Name 118816 0
Terry Haines
Address 118816 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118816 0
Australia
Phone 118816 0
+61 433596526
Fax 118816 0
Email 118816 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
Potentially identifiable and sensitive data being collected


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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of tailored COVID-19 messages for vulnerable Australians: A study protocol.2023https://dx.doi.org/10.1371/journal.pone.0280865
N.B. These documents automatically identified may not have been verified by the study sponsor.