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Trial registered on ANZCTR


Registration number
ACTRN12620000806965
Ethics application status
Approved
Date submitted
23/06/2020
Date registered
10/08/2020
Date last updated
7/07/2021
Date data sharing statement initially provided
10/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Communicating Heart Disease Risk: Development and testing of a health-literate decision aid for people with low health literacy
Scientific title
Development and testing of an online health-literate decision aid to reduce cardiovascular disease (CVD) risk for people with low health literacy
Secondary ID [1] 300311 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 315915 0
Condition category
Condition code
Cardiovascular 314187 314187 0 0
Coronary heart disease
Public Health 316288 316288 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: 3x2 factorial design to test the effect of health-literate design (low health literacy, standard, or basic Heart Foundation patient information) and risk format (explaining CVD risk only, or CVD risk + heart age) on understanding, intentions and behaviour. Heart age is determined by using the CVD risk equation to ascertain the age that someone of the same gender as the participant, but with ideal levels of risk factors (e.g. non-smoker) would be if they had the same percentage CVD risk as the participant.

Methods: A national sample will be recruited for an online survey through Qualtrics, with stratified education, gender and age groups (45-74 years). Participants will all initially complete a CVD risk assessment. If blood pressure or cholesterol are not known, the average by age/gender based on non-diabetic participants in the Australian Diabetes, Obesity and Lifestyle Study (AusDiab) cohort will be used (accessed via CI Doust), and all participants will be advised to see a GP for a more accurate risk assessment.
Participants will then be randomised to see one of six different versions of the results page: either a version aimed at lower health literacy, a standard version, or one as the Heart Foundation present it, and each of those three either with percentage risk of having heart attack or stroke, or percentage risk plus heart age.
After this, participants will have the opportunity to look at how their risk will change if they change various factors (decision aid). This again is different based on 3 randomised conditions:
1. Those who saw either of the Heart Foundation results pages will receive a decision aid based on the cvdcheck.org.au website’s calculator, which allows participants to alter any of their risk factors (e.g. blood pressure levels, age, smoking status) and then presents this new result against their actual result.
2. Those who saw their result in the standard version will receive a more interactive decision aid, whereby a menu with various potential changes (e.g. taking medication, improving diet or stopping smoking) are presented to the participant, and they can select one of these in order to see how it will affect their CVD risk. They will also receive information about the change they have selected (e.g. exactly what type of diet they should be eating) and the pros and cons of making this change. They are able to then go back to the menu page again in order to select a different ‘change’ should they wish to.
3. Those who received their result in the low health literacy version will see the same menu page as in the standard version, and will also see their new risk percentage in the same way, however the information provided about each of the changes will be presented in a format suited to the universal precautions approach (e.g. simpler language, images).
Following the decision aid, participants will be asked questions regarding their intentions for behaviour change (e.g. will they see their GP to enquire about medications, will they do more exercise) and their reactions to seeing their risk.
Finally, there is an ‘action plan’ stage, which again differs between the conditions:
1. Participants who have been seeing the Heart Foundation version will receive the follow-up that the National Heart Foundation of Australia provide to users who complete their Heart Age Calculator online. They can select whether to see information on diet, physical activity or smoking and are then presented with the relevant information.
2. Participants in the standard condition will receive a simple action plan. They will be asked to either make a plan for physical activity, smoking or diet, and then will receive the following prompts: to create a goal, to think about how to monitor their progress, to describe why they feel able to achieve the goal, and when they plan to achieve it by.
3. Participants in the low health literacy condition will receive an action plan which has been tested by one of the investigators. They are also asked to select either physical activity, diet or smoking, and are then guided through the process of creating an action plan based on implementation intentions (if-then).

The six conditions that participants can be randomised to are summarised below:
1. low health literacy version of results showing percentage risk and heart age - low health literacy version of decision aid - low health literacy version of action plan
2. low health literacy version of results showing percentage risk only age - low health literacy version of decision aid - low health literacy version of action plan
3. standard version of results showing percentage risk and heart age - standard version of decision aid - standard version of action plan
4. standard version of results showing percentage risk only - standard version of decision aid - standard version of action plan
5. heart foundation version of results showing percentage risk and heart age - heart foundation version of decision aid - heart foundation version of action plan
6. heart foundation version of results showing percentage risk only - heart foundation version of decision aid - heart foundation version of action plan

The duration of the survey will differ between groups, however we expect participants to take between 10 and 20 minutes to complete it. We are initially going to run a ‘soft launch’ of the survey, with only a few participants, to get a better understanding of its length.

One month following the completion of this intervention, the participants will receive a further survey to determine whether they have indeed changed their behaviour, as well as recall of their percentage risk and heart age results.
Intervention code [1] 316584 0
Prevention
Intervention code [2] 318098 0
Behaviour
Intervention code [3] 318099 0
Lifestyle
Comparator / control treatment
The design is 3x2 and therefore participants are randomised to one of six conditions, all of which will be compared against one another
Control group
Active

Outcomes
Primary outcome [1] 322577 0
Intention to change lifestyle (composite outcome, found by averaging results across: intention to increase physical activity, intention to improve diet, intention to reduce smoking if relevant). This is assessed by the participant's level of agreement/disagreement on a 7-item Likert-type scale to three post-intervention statements: 'I intend to smoke less in the next 4 weeks' (if they indicated they smoke in an earlier question in the survey), 'I intend to improve my diet in the next 4 weeks', 'I intend to increase the amount of physical activity I do in the next 4 weeks'
Timepoint [1] 322577 0
Intentions measured immediately post-intervention
Secondary outcome [1] 378981 0
Self-reported behaviour change after 1 month, measured through a survey sent to participants one month post-intervention. Participants will be asked questions regarding whether or not they smoke, and if so how many cigarettes per day. They will be asked about their levels of vigorous and moderate intensity exercise. They will be asked about how many snacks, sports drinks, vegetables and fruits they eat or drink every day. These questions are specific to this study
Timepoint [1] 378981 0
One month post-intervention
Secondary outcome [2] 384721 0
Change in intention to see GP (composite outcome, found by averaging results across three questions regarding intention to see the GP for three different medication types). This is assessed by the participant's level of agreement/disagreement on a 7-item Likert-type scale to three post-intervention statements: 'I intend to talk to my GP about taking blood pressure lowering medication in the next 4 weeks', 'I intend to talk to my GP about taking cholesterol lowering medication in the next 4 weeks', 'I intend to talk to my GP about taking aspirin in the next 4 weeks'
Timepoint [2] 384721 0
Intentions measured immediately post-intervention
Secondary outcome [3] 384722 0
Recall of results - participants will be asked to recall what their percentage risk was, and what their heart age was (if they were presented with it)
Timepoint [3] 384722 0
Measured immediately post-intervention
Secondary outcome [4] 384723 0
Decisional uncertainty, as measured by the SURE scale
Timepoint [4] 384723 0
Measured immediately post=intervention
Secondary outcome [5] 384724 0
Risk perception, assessed as the perceived risk category that the result indicated (high, medium or low)
Timepoint [5] 384724 0
Measured immediately post-intervention
Secondary outcome [6] 384725 0
Emotional response, assessed using a 6-item Likert-type scale (from 0 [none of this feeling] to 10 [a lot of this feeling]). The three positive (hopeful, optimistic, enthusiastic) and the three negative (afraid, anxious, worried) subscales will be scored based on the average of the relevant items
Timepoint [6] 384725 0
Measured immediately post-intervention
Secondary outcome [7] 384726 0
Perceived credibility will be assessed with a 4 item Likert-type scale (from 1 [completely disagree] to 7 [completely agree]) scored as the average of the items (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 [7] 384726 0
Measured immediately post-intervention

Eligibility
Key inclusion criteria
Individuals will be eligible if they are aged 45-74 and are not already known to be at high risk of heart disease, and are not currently taking medication to prevent heart disease.
Minimum age
45 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with established CVD or taking CVD prevention medication will be excluded.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
6/10/2020
Actual
23/10/2020
Date of last participant enrolment
Anticipated
Actual
12/11/2020
Date of last data collection
Anticipated
Actual
5/03/2021
Sample size
Target
850
Accrual to date
Final
859
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304732 0
Charities/Societies/Foundations
Name [1] 304732 0
National Heart Foundation of Australia
Country [1] 304732 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Edward Ford Building A27
The University of Sydney
NSW
2006
Country
Australia
Secondary sponsor category [1] 306499 0
None
Name [1] 306499 0
Address [1] 306499 0
Country [1] 306499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305157 0
University of Sydney
Ethics committee address [1] 305157 0
Ethics committee country [1] 305157 0
Australia
Date submitted for ethics approval [1] 305157 0
Approval date [1] 305157 0
15/06/2020
Ethics approval number [1] 305157 0

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

Contacts
Principal investigator
Name 99430 0
Dr Carissa Bonner
Address 99430 0
Edward Ford Building A27
The University of Sydney
NSW
2006
Country 99430 0
Australia
Phone 99430 0
+61 2 9351 7125
Fax 99430 0
Email 99430 0
carissa.bonner@sydney.edu.au
Contact person for public queries
Name 99431 0
Carissa Bonner
Address 99431 0
Edward Ford Building A27
The University of Sydney
NSW
2006
Country 99431 0
Australia
Phone 99431 0
+61 2 9351 7125
Fax 99431 0
Email 99431 0
carissa.bonner@sydney.edu.au
Contact person for scientific queries
Name 99432 0
Carissa Bonner
Address 99432 0
Edward Ford Building A27
The University of Sydney
NSW
2006
Country 99432 0
Australia
Phone 99432 0
+61 2 9351 7125
Fax 99432 0
Email 99432 0
carissa.bonner@sydney.edu.au

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.