Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000910404p
Ethics application status
Submitted, not yet approved
Date submitted
31/07/2025
Date registered
21/08/2025
Date last updated
21/08/2025
Date data sharing statement initially provided
21/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Heart Health Literacy Toolkit: Targeted Cardiovascular Disease (CVD) risk screening with health literacy support by Short Message Service (SMS) in general practice
Scientific title
Health literacy support for targeted CVD risk screening invitations by SMS in general practice patients
Secondary ID [1] 315009 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 338344 0
Condition category
Condition code
Cardiovascular 334643 334643 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research aim: The aim of this study is to test the impact on patient health literacy of an enhanced CVD risk screening model that integrates the Heart Health Literacy Toolkit before, during and after the Heart Health Check.

Research setting: The trial will be initiated via text message sent by 10 participating general practices in Western Sydney Local Health District. Research activities will be conducted online.

Methodological approach: We will conduct a non-blinded randomised controlled trial [Hybrid effectiveness-implementation trial (type 1)].

Eligible participants will be identified via general practice clinical audit software. Each practice will be asked to identify 600 eligible participants. Eligible participants at each practice will be randomised to either the intervention or control arm. General practices will send Heart Health Check recall SMS to all eligible participants (intervention and control) asking them to come in for cardiovascular screening. GoShare Plus software is an add on to clinical practice software.

Intervention (enhanced CVD screening model – recall message with Heart Health Literacy Toolkit). Eligible participants will be sent a recall SMS with embedded link to a study landing page, with study information, study consent and link to the baseline survey. Participants will only be enrolled in the study if they click on the link in the SMS, consent to participate and complete the baseline survey. On completion of the survey they will be sent an SMS with an embedded link to the Heart Health Literacy Toolkit (www.checkyourheart.com.au). There is no requirement for participants to click on the link, or to view specific content. Participants can interact with the website as much or as little as they like. The website includes a video overview of the Heart Health Check, knowledge quiz, interactive risk communication tool, lifestyle change planning tools and medication decision aids. A reminder SMS will be sent at the 2 week timepoint to those people who did not open the embedded link in the initial SMS. At the 13 week timepoint, participants who completed the baseline survey will be sent a link to the follow-up survey via SMS. Participant commitment consists of two online surveys, 13 weeks apart, each expected to take approximately 10 minutes to complete.

Recall text messages will be sent in bulk via GoShare Plus software (add on to clinical practice software) by relevant staff within the participating general practice e.g. GP, practice nurse or practice manager. The recall message content will be between 200 - 230 characters long and broken into two sentences. We anticipate the reader will engage with the message for no longer than 1 minute.

Reach and content engagement will be reported using a live dashboard developed by Healthily who have developed the GoShare Plus technology. The Dashboard will report on the number of SMS sent, the open rate per practice, the open rate of SMS landing page links per practice and the open rate of SMS links to the Heart Health Literacy Toolkit. Participants in the intervention will also be asked to self-report their use of the Heart Health Literacy Toolkit during the 13 week follow-up survey.
Intervention code [1] 331603 0
Prevention
Intervention code [2] 331604 0
Early detection / Screening
Intervention code [3] 331606 0
Behaviour
Comparator / control treatment
Participants in the control group will be sent a recall SMS with embedded link to a study landing page, with study information, study consent and link to the baseline survey. A reminder SMS will be sent at the 2 week timepoint to those people who did not open the embedded link in the initial SMS. At the 13 week timepoint, participants will be sent a link to the follow-up survey via SMS. After completion of the follow-up survey, participants in the control group will receive an SMS with access to the Heart Health Literacy Toolkit.
Control group
Active

Outcomes
Primary outcome [1] 342323 0
Patient health literacy level
Timepoint [1] 342323 0
Baseline and 13 weeks after intervention (recall SMS)
Secondary outcome [1] 450314 0
Change in patient knowledge of cardiovascular disease
Timepoint [1] 450314 0
Baseline and 13 weeks after intervention (recall SMS)
Secondary outcome [2] 450329 0
Engagement with Heart Health Checks
Timepoint [2] 450329 0
13 weeks after intervention (recall SMS)
Secondary outcome [3] 450497 0
Engagement with SMS recall
Timepoint [3] 450497 0
13 weeks after intervention (recall SMS)
Secondary outcome [4] 451016 0
Engagement with Heart Health Literacy Toolkit
Timepoint [4] 451016 0
13 weeks after intervention (recall SMS)
Secondary outcome [5] 451025 0
Acceptability of Heart Health Literacy Toolkit
Timepoint [5] 451025 0
13 weeks after intervention (recall SMS)

Eligibility
Key inclusion criteria
We will aim to recruit 10 general practices across Western Sydney to participate in this trial.

General practice inclusion criteria:
- General practices must have accreditation from one of the five Australian accreditation agencies recognised by the RACGP – AGPAL, Quality Practice Accreditation, Australian Council on Healthcare Standards, Global-Mark Pty Ltd or Institute for Healthy Communities Australia Certification Pty Ltd.
- Practices must allow Healthily to enable GoShare Plus functionality in CAT4.

Eligible individual participants will be identified via general practice clinical audit software.
- Aged 45 to 74 years
- Aboriginal and/or Torres Strait Islander person aged 30-79*
- Person living with diabetes aged 35-79
- No recorded diagnosis of CVD
- No health assessment or Heart Health Check in the last 24 months
- Active patient of the practice based on RACGP definition of active patient (at least 3 visits in the last 2 years)
- Sufficient English ability to complete survey
Minimum age
30 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- If the patient has opted out of research projects or SMS and is included in the practice opt-out register
- Does not have a valid mobile phone number

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is n=900 where randomised 1:1 to either intervention arm (enhanced CVD screening model with Heart Health Literacy Toolkit) or control arm (targeted SMS recall for CVD screening). The design has >90% power to detect a 0.25 unit difference (standardised effect size of 0.33) in validated Health Literacy Questionnaire domains (Having sufficient information to manage my health; Actively managing my health), with up to 50% dropout.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319574 0
Government body
Name [1] 319574 0
National Health and Medical Research Council
Country [1] 319574 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 322068 0
None
Name [1] 322068 0
Address [1] 322068 0
Country [1] 322068 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318137 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 318137 0
Ethics committee country [1] 318137 0
Australia
Date submitted for ethics approval [1] 318137 0
10/03/2025
Approval date [1] 318137 0
Ethics approval number [1] 318137 0

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

Contacts
Principal investigator
Name 143234 0
A/Prof Carissa Bonner
Address 143234 0
Sydney School of Public Health, Edward Ford Building (A27), The University of Sydney NSW 2006
Country 143234 0
Australia
Phone 143234 0
+61293517125
Fax 143234 0
Email 143234 0
[email protected]
Contact person for public queries
Name 143235 0
Carissa Bonner
Address 143235 0
Sydney School of Public Health, Edward Ford Building (A27), The University of Sydney NSW 2006
Country 143235 0
Australia
Phone 143235 0
+61293517125
Fax 143235 0
Email 143235 0
[email protected]
Contact person for scientific queries
Name 143236 0
Carissa Bonner
Address 143236 0
Sydney School of Public Health, Edward Ford Building (A27), The University of Sydney NSW 2006
Country 143236 0
Australia
Phone 143236 0
+61293517125
Fax 143236 0
Email 143236 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Direct request to Principal Investigator (Carissa Bonner: [email protected])

Are there extra considerations when requesting access to 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.