Trial Review

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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
ACTRN12623001246673
Ethics application status
Approved
Date submitted
2/11/2023
Date registered
1/12/2023
Date last updated
22/09/2024
Date data sharing statement initially provided
1/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing different ways to explain coronary calcium artery scoring for support of shared decision making in adults who do not have a history of cardiovascular disease
Scientific title
Testing different ways to explain coronary calcium artery scoring for support of shared decision making in adults who do not have a history of cardiovascular disease: A Study on Participant Understanding of cardiovascular disease risk
Secondary ID [1] 310886 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 331939 0
Condition category
Condition code
Cardiovascular 328664 328664 0 0
Coronary heart disease
Public Health 328665 328665 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: The study will be a randomised experiment. We will conduct a national survey recruited through Dynata to experimentally test different content options amongst consumers with varying health literacy. A 2 x 2 factorial design will test how to present risk assessment and management options (basic vs detailed) and uncertainty (implicit vs explicit) to enhance understanding.

Methods: A national sample will be recruited for an online survey through Qualtrics, with stratified education, gender and age groups (45-79 years). Participants will complete a 10-minute survey where they will: 1) respond to questions about demographics and health literacy; and 2) respond to various information: group 1 and 3 will receive basic description of CVD risk factors/management options, group 2 and 4 will receive detailed description of the triage method and intervention effects. We will also compare standard presentation of probabilities with a version that has explicit information about different types of uncertainty: aleatory (randomness of future events, represented implicitly via probabilities) for group 1 and 2; and epistemic (with explicit statements about uncertainty around numeric estimates and the quality of underlying evidence) for group 3 and 4. There will be two outcome scenarios within each of the four groups. Participants will be shown a hypothetical scenario of a person receiving an intermediate result for their heart disease risk, which will be reclassified as either low risk or high risk. Participants will receive a debriefing document at the end to explain the aims of the study and that the data is based on a hypothetical scenario which do not apply to their own situation. The survey is anonymous.

The eight groups participants can be randomised to are summarised below:
1a. Information: Basic; Uncertainty: Implicit; Final risk: Low
1b. Information: Basic; Uncertainty: Implicit; Final risk: High
2a. Information: Detailed; Uncertainty: Implicit; Final risk: Low
2b. Information: Detailed; Uncertainty: Implicit; Final risk: High
3a. Information: Basic; Uncertainty: Explicit; Final risk: Low
3b. Information: Basic; Uncertainty: Explicit; Final risk: High
4a. Information: Detailed; Uncertainty: Explicit; Final risk: Low
4b. Information: Detailed; Uncertainty: Explicit; Final risk: High
Intervention code [1] 327307 0
Prevention
Intervention code [2] 327308 0
Lifestyle
Intervention code [3] 327309 0
Behaviour
Comparator / control treatment
The design is 2x2, There are two different risk outcomes within each group, therefore participants will be randomised to one of eight groups, all of which will be compared against one another.


'Comparator' Information: Basic; Uncertainty: Implicit; Final risk: Low
Control group
Active

Outcomes
Primary outcome [1] 336460 0
Understanding of CVD risk assessment
Assessment method [1] 336460 0
Knowledge-based multiple choice questions containing 6 items. Participants will be asked questions regarding their understanding of CVD risk assessment. These questions are specific to this study.
Timepoint [1] 336460 0
Immediately post-intervention
Primary outcome [2] 336461 0
Understanding of management options
Assessment method [2] 336461 0
A 4 items, 2 response (Yes or No) Decisional Conflict Scale SURE Test: ‘Do you feel sure about the best choice for you?’, ‘Do you know the benefits and risks of each option?’, ‘Are you clear about which benefits and risks matter most to you?’, ‘Do you have enough information to make a choice?’
Timepoint [2] 336461 0
Immediately post-intervention
Secondary outcome [1] 428479 0
Intentions to get Coronary Calcium Artery Scoring (CACS) scan
Assessment method [1] 428479 0
The participant's level of agreement/disagreement on a 7-item Likert-type scale to the post-intervention statement: 'I intend to get the CACS heart scan in the next 4 weeks'
Timepoint [1] 428479 0
Immediately post-intervention
Secondary outcome [2] 428480 0
Risk perception
Assessment method [2] 428480 0
A total of 8 items multiple choice on perceived risk category and understanding of information and uncertainty. Participants will be asked questions about the hypothetical scenario shown to them regarding the initial/final/ overall risk results, risk of heart attack or stroke, risk calculator results and heart scan results. These questions are specific to this study.
Timepoint [2] 428480 0
Immediately post-intervention
Secondary outcome [3] 428481 0
Perceived credibility
Assessment method [3] 428481 0
A 4-item Likert scale (from 1 [Strongly disagree] to [Strongly agree]): ‘I felt that the numbers received were “my numbers”’, ‘I found the results to be written personally for me’, ‘I felt that the information was relevant to me’, ‘I felt that the information was designed specifically for me’
Timepoint [3] 428481 0
Immediately post-intervention
Secondary outcome [4] 428482 0
Emotional response
Assessment method [4] 428482 0
A 6-item Likert-type scale (from 1 [Not at all] to 7 [extremely]). The three positive (Assured, Hopeful, Relieved) and the three negative (afraid, anxious, worried) subscales will be scored based on the average of the relevant items.
Timepoint [4] 428482 0
Immediately post intervention
Secondary outcome [5] 429055 0
Intentions to discuss with GP about medication
Assessment method [5] 429055 0
The participant's level of agreement/disagreement on a 7-item Likert-type scale to the post-intervention statements: 'I intend to talk to my GP about taking medication in the next 4 weeks'
Timepoint [5] 429055 0
Immediately post-intervention
Secondary outcome [6] 429056 0
Intentions to discuss with GP about lifestyle modification
Assessment method [6] 429056 0
The participant's level of agreement/disagreement on a 7-item Likert-type scale to the post-intervention statements: 'I intend to make healthy lifestyle changes in the next 4 weeks'.
Timepoint [6] 429056 0
Immediately post-intervention

Eligibility
Key inclusion criteria
Individuals will be eligible if they are aged 45-79; living in Australia, able to communicate and read English; never had a heart attack or stroke nor been diagnosed with a CVD.
Minimum age
45 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The survey itself will be hosted on the Qualtrics platform. The Qualtrics platform includes a “Randomiser” tool to evenly allocate participants to each condition. Participants will be evenly randomised to one of the eight groups, participants only be exposed to one group. A debrief document will only be available at the end of the survey. There is no way participants will have knowledge of other groups and which group they are allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Qualtrics platform includes a “Randomizer” tool to evenly allocate participants to one of the eight groups,
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/12/2023
Actual
4/12/2023
Date of last participant enrolment
Anticipated
15/12/2023
Actual
12/12/2023
Date of last data collection
Anticipated
15/12/2023
Actual
12/12/2023
Sample size
Target
1624
Accrual to date
Final
1629
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315144 0
Charities/Societies/Foundations
Name [1] 315144 0
National Heart Foundation of Australia
Country [1] 315144 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Country
Australia
Secondary sponsor category [1] 317164 0
None
Name [1] 317164 0
Country [1] 317164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314082 0
The University of Sydney Human Research Ethics Committees
Ethics committee address [1] 314082 0
Ethics committee country [1] 314082 0
Australia
Date submitted for ethics approval [1] 314082 0
16/08/2023
Approval date [1] 314082 0
18/10/2023
Ethics approval number [1] 314082 0
2023/671

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 130346 0
Dr Carissa Bonner
Address 130346 0
Edward Ford Building A27, The University of Sydney, NSW 2006
Country 130346 0
Australia
Phone 130346 0
+61293517125
Fax 130346 0
Email 130346 0
carissa.bonner@sydney.edu.au
Contact person for public queries
Name 130347 0
Carissa Bonner
Address 130347 0
Edward Ford Building A27, The University of Sydney, NSW 2006
Country 130347 0
Australia
Phone 130347 0
+61293517125
Fax 130347 0
Email 130347 0
carissa.bonner@sydney.edu.au
Contact person for scientific queries
Name 130348 0
Carissa Bonner
Address 130348 0
Edward Ford Building A27, The University of Sydney, NSW 2006
Country 130348 0
Australia
Phone 130348 0
+61293517125
Fax 130348 0
Email 130348 0
carissa.bonner@sydney.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.