Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000617763
Ethics application status
Approved
Date submitted
14/04/2022
Date registered
26/04/2022
Date last updated
26/04/2022
Date data sharing statement initially provided
26/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 3, What communication strategy is most effective for both vulnerable and community group populations.
Scientific title
Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 3, What communication strategy is most effective for both vulnerable and community group populations.
Secondary ID [1] 306947 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study of ACTRN12622000606785 and ACTRN12622000605796.

Health condition
Health condition(s) or problem(s) studied:
COVID-19 infection 326058 0
Condition category
Condition code
Public Health 323365 323365 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a "helix" counterbalanced randomised trial design. Participants are randomly ordered to receive two interventions across two different context areas related to COVID-19 health.
The two arms of the study are:
1. Conversational training approach provided by a General Practitioner ('talking head').
2. Direct information provision provided by a General Practitioner ('talking head').

The two context areas are:
1. Encouraging people to ask workers attending their home if they are vaccinated or not
2. Encouraging people to avoid sharing food, utensils etc. at gatherings.

The arms of study differ by the language and tone. The conversational training approach provides a health message (one of the two context areas mentioned above), in a peer-to-peer fashion that is more about giving advice. The Direct information provision arm, provides a health message that is direct and more one-sided in tone.
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 both arms of the intervention, with each intervention level being presented in a different context area as per a counterbalanced 'helix' trial approach (DOI: https://doi.org/10.1186/s13012-019-0896-0).
It is anticipated that these videos will be observed over an approximate 10minutes period. Participants will observe the videos in their own home or at a partner organisation service provider location relative to their vulnerable population subgroup (e.g. meeting place for our ATSI subgroup).
Progression of the participant through both of the intervention/context combinations will be monitored via the online data collection platform (Qualtrics). Qualtrics enables extraction of all responses including partial completions, and allows tracking and recording of in-complete survey entries.
Intervention code [1] 323387 0
Behaviour
Comparator / control treatment
The comparators in this study are the different levels of the interventions.
Specifically we will be comparing:
1. the effectiveness of health information provision delivered through a conversational training approach by a General Practitioner and through a direct information provision approach by a General Practitioner.
Comparisons are not being made between context areas 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] 331102 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. Has viewing this video made you feel more or less inclined to ask a person visiting your home for work if they have had a COVID-19 vaccine before allowing them to enter? Since watching the video, I feel:

2. Has viewing this video made you feel more or less inclined to bring your own plates, cutlery, cups and utensils to social gatherings? Since watching this video, I feel:

Timepoint [1] 331102 0
Immediately following viewing the intervention
Primary outcome [2] 331103 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 asking people visiting their home to work whether they have had a COVID-19 vaccine before letting them enter, how likely would you be to encourage them to do so?

2. If you had a family member or friend who was unsure about whether people should bring their own plates, cups, and utensils to social gatherings, how likely would you be to encourage them to bring their own?
Timepoint [2] 331103 0
Immediately following viewing the intervention.
Secondary outcome [1] 408745 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.
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] 408745 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
We have 7 specific subgroup populations of interest for this study, below outlines the group and it's associated inclusion criteria.
1. People living with a disability and their carers: Participants must be 18 years of age or older, reside in Australia, be currently living with a disability or is a carer for someone who has a disability.
2. Aged care workers: Participants must be aged 18 years or older, reside in Australia, and be an aged care worker.
3. Refugee and asylum seekers: Participants must be aged 18 years or older, reside in Australia as a refugee or asylum seeker and be able to read/speak English, Dari or Sinhalese.
4. Deaf, hard of hearing people: Participants must be aged 18 years or older, reside in Australia and are deaf or those that are hard of hearing.
5. Aboriginal and Torres Strait Islander people: Participants must be aged 18 year or older, reside in Australia and have a heritage of Aboriginal or Torres Strait Islander.
6. Street-based sex workers: Participants must be aged 18 years or older, reside in Australia and be working as a street-based sex worker.
7. General Australian community: Participants must be aged 18 years or older, and reside in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Across all groups key exclusion criteria include:
1. Anyone who is not currently living in Australia.
2. Anyone who is under the age of 18 years.

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 2 intervention arms across 2 different context areas related to COVID-19 health. The ordering of presentation of intervention combinations is randomly assigned through the Qualtrics data collection platform.
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 the effectiveness of health information provision delivered through a conversational training approach by a General Practitioner and through a direct information provision approach by a General Practitioner.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311264 0
Government body
Name [1] 311264 0
Australian Government Department of Health (Medical Research Future Fund)-Communication Strategies and Approaches During Outbreaks)
Country [1] 311264 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] 312622 0
None
Name [1] 312622 0
Address [1] 312622 0
Country [1] 312622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310776 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310776 0
Ethics committee country [1] 310776 0
Australia
Date submitted for ethics approval [1] 310776 0
31/03/2022
Approval date [1] 310776 0
08/04/2022
Ethics approval number [1] 310776 0
30698

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

Contacts
Principal investigator
Name 118822 0
Prof Terry Haines
Address 118822 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118822 0
Australia
Phone 118822 0
+61 433596526
Fax 118822 0
Email 118822 0
[email protected]
Contact person for public queries
Name 118823 0
Terry Haines
Address 118823 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118823 0
Australia
Phone 118823 0
+61 433596526
Fax 118823 0
Email 118823 0
[email protected]
Contact person for scientific queries
Name 118824 0
Terry Haines
Address 118824 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118824 0
Australia
Phone 118824 0
+61 433596526
Fax 118824 0
Email 118824 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
No additional documents have been identified.