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Trial registered on ANZCTR


Registration number
ACTRN12623000777695p
Ethics application status
Submitted, not yet approved
Date submitted
5/07/2023
Date registered
18/07/2023
Date last updated
18/07/2023
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into the effect of a text-message based intervention on managing high blood pressure for people in the community.
Scientific title
An investigation into the effect of a consumer-led text-message based intervention on managing high blood pressure medication for people in the community
Secondary ID [1] 310004 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
CHeCCK
(Consumer-led Hypertension Care in Community-based Kiosks)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Hypertension 330511 0
Condition category
Condition code
Cardiovascular 327358 327358 0 0
Hypertension
Public Health 327495 327495 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potential participants will be identified after completing a health check at a SiSU Health(TM) check station in Priceline pharmacies in all states of Australia excluding New South Wales (NSW). A formula within the SiSU health check machines will check if participants meet all inclusion criteria. If eligible a notification page will appear on screen. Participants will be given the following choices:
- “Yes, I’m in!” – participant will be enrolled in the study and emailed the participant information sheet.
- “Unsure need more information” – Participant will be sent the Participant Information Statement (PIS) along with a link to opt-in to the study.
- “No, I don’t want to take part” – The potential participant will not be enrolled in the study.

Eligible participants will receive an email from SiSU Health with specific, actionable advice, and participants randomised to intervention will receive a series of semi-personalised text messages aimed to guide, support, remind and educate on blood pressure (BP) management.

The CHeCCK (Consumer-led Hypertension Care in Community-based Kiosks) intervention is a co-designed intervention with content developed and iteratively improved through multiple review cycles by academics, clinicians and consumers. The content aims to inform participants about the nature and consequences of high BP and prompt action, and behaviour changes to improve BP management. Participants will receive 15 text messages over 30 days, the text messages will provide information on 1) high blood pressure, 2) where participants should access care and what to expect from a visit to a health care provider 3) why managing blood pressure is important 4) lifestyle changes for managing high blood pressure and 5) the value of medications for managing high blood pressure. The content of messages will be tailored according to whether the participant’s BP is measured as high BP (greater than or equal to 140-159 and/ or 90-99 mmHg) or very high BP (greater than or equal to 160 and/ or 100mm Hg).

The content of the messages will be tailored based on the participant's BP, the messages to those with very high BP have greater urgency, than those to people with people with high BP.

We will check if the messages have been delivered to the intended recipient but we will not check if they read the messages.

Participants randomised to the control group with receive usual care from SiSU Health. SiSU Health have created a one-page automated email which users who record a high blood pressure reading will receive. This email contains an easy-to-understand summary of what it means to have high blood pressure, common causes, a recommendation to re-check your blood pressure and if still high to see your doctor. For this study we will use this email as the standard of care for the control arm.
Intervention code [1] 326430 0
Prevention
Comparator / control treatment
Participants in the control group will receive an email from SiSU Health with specific, actionable advice only.
Control group
Active

Outcomes
Primary outcome [1] 335227 0
Change in BP medication

Participants will be asked (via text message) to answer Yes or No to a question asking them if their healthcare practitioner has changed their BP-lowering medication – e.g., increased dose, added new BP medicines, or changed current medicines.

Timepoint [1] 335227 0
Once during the period 30-45 days post randomisation
Secondary outcome [1] 423554 0
Blood pressure related self-efficacy.

Health self-efficacy will be measured (via survey) using a modified version of the Patient-Reported Outcome Measurement Information System (PROMIS)- self-efficacy measure for managing chronic conditions. (Gruber-Baldini et al. 2017).
This 5-item questionnaire will ask participants to rate their confidence in monitoring their BP, managing their emotions, and managing medications and treatment.
Timepoint [1] 423554 0
Once during the period 30-45 days post randomisation
Secondary outcome [2] 423555 0
Blood pressure related knowledge.

BP-related health literacy will be measured (via survey) using a modified version of the Hypertension Knowledge questionnaire. (Han et al. 2011)
This 6-item questionnaire will ask participants questions related to measurement, and management of hypertension.
Timepoint [2] 423555 0
Once during the period 30-45 days post randomisation
Secondary outcome [3] 423556 0
Blood pressure management. The 5 questions will be based on lifestyle targets recommended by the Heart Foundation. Participants will be asked if they have changed any aspect of their lifestyle to meet these recommendations.

Participants will be asked (via survey) to report changes to their diet.
Timepoint [3] 423556 0
Once during the period 30-45 days post randomisation
Secondary outcome [4] 423557 0
Blood pressure management. The 5 questions will be based on lifestyle targets recommended by the Heart Foundation. Participants will be asked if they have changed any aspect of their lifestyle to meet these recommendations.

Participants will be asked (via survey) to report changes to their physical activity.
Timepoint [4] 423557 0
Once during the period 30-45 days post randomisation
Secondary outcome [5] 424049 0
Blood pressure management. The 5 questions will be based on lifestyle targets recommended by the Heart Foundation. Participants will be asked if they have changed any aspect of their lifestyle to meet these recommendations.

Participants will be asked (via survey) to report changes to their alcohol consumption.
Timepoint [5] 424049 0
30-45 days post randomisation
Secondary outcome [6] 424051 0
Blood pressure management. The 5 questions will be based on lifestyle targets recommended by the Heart Foundation. Participants will be asked if they have changed any aspect of their lifestyle to meet these recommendations.

Participants will be asked (via survey) to report changes to their smoking status.
Timepoint [6] 424051 0
Once during the period 30-45 days post randomisation
Secondary outcome [7] 424052 0
Blood pressure management. The 5 questions will be based on lifestyle targets recommended by the Heart Foundation. Participants will be asked if they have changed any aspect of their lifestyle to meet these recommendations.

Participants will be asked (via survey) to report changes to their stress management.
Timepoint [7] 424052 0
Once during the period 30-45 days post randomisation
Secondary outcome [8] 424053 0
Blood pressure checked with GP

Participants will be asked (via text message) to reply Yes or No to questions asking them if they or other doctor in the last 30 days. This question will be asked 30 days post randomisation.
Timepoint [8] 424053 0
Once during the period 30-45 days post randomisation

Eligibility
Key inclusion criteria
Participants will be included if they meet all criteria and provide electronic consent:
1. Aged greater than or equal to 18 years old.
2. Record a BP reading of greater than or equal to 140 mmHg systolic and/or greater than or equal to 90 mm Hg diastolic pressure at a SiSU Health check station.
3. Own an operational texting-capable mobile phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation cannot be concealed from participants or research staff members conducting data entry and intervention set up. Statistical analyses will be pre-specified in a statistical analysis plan, and the statistician will not be aware of participant allocation prior to data lock.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation, using a computerised system, will be 1:1 into control and intervention groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be pre-specified in a statistical analysis plan, and the statistician will not be aware of participant allocation prior to data lock.

The data will be analysed by intention-to-treat. We will use baseline data for descriptive statistics to describe the participant characteristics.

The following outcomes will be compared between intervention and control groups at 30 days from randomisation.
• Primary outcome – change in BP medication.
• Secondary outcomes:
o BP-related self-efficacy
o overall BP knowledge
o self- reported change to diet, physical activity, smoking, alcohol, stress management
o visit to GP to discuss their BP

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
906
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314181 0
Other Collaborative groups
Name [1] 314181 0
Digital Health CRC
Country [1] 314181 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Westmead Applied Research Centre,
Faculty of Medicine and Health
The University of Sydney,
Level 5, Entrance 10, Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 316098 0
None
Name [1] 316098 0
Address [1] 316098 0
Country [1] 316098 0
Other collaborator category [1] 282744 0
Commercial sector/Industry
Name [1] 282744 0
SiSU Health
Address [1] 282744 0
442 Auburn Road, Hawthorn, Victoria, 3122
Country [1] 282744 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313309 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313309 0
Ethics committee country [1] 313309 0
Australia
Date submitted for ethics approval [1] 313309 0
26/06/2023
Approval date [1] 313309 0
Ethics approval number [1] 313309 0

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

Contacts
Principal investigator
Name 127686 0
Dr Edel O'Hagan
Address 127686 0
Westmead Applied Research Centre, Faculty of Medicine and Health,
The University of Sydney,
Level 5, Entrance 10,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
Country 127686 0
Australia
Phone 127686 0
+61404474715
Fax 127686 0
Email 127686 0
edel.ohagan@sydney.edu.au
Contact person for public queries
Name 127687 0
Edel O'Hagan
Address 127687 0
Westmead Applied Research Centre, Faculty of Medicine and Health,
The University of Sydney,
Level 5, Entrance 10,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
Country 127687 0
Australia
Phone 127687 0
+61404474715
Fax 127687 0
Email 127687 0
edel.ohagan@sydney.edu.au
Contact person for scientific queries
Name 127688 0
Edel O'Hagan
Address 127688 0
Westmead Applied Research Centre, Faculty of Medicine and Health,
The University of Sydney,
Level 5, Entrance 10,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
Country 127688 0
Australia
Phone 127688 0
+61404474715
Fax 127688 0
Email 127688 0
edel.ohagan@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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19570Study protocol  edel.ohagan@sydney.edu.au We intend to publish the protocol in a peer review... [More Details]
19571Statistical analysis plan    We will upload the SAP to a data sharing platform ... [More Details]
19572Clinical study report  edel.ohagan@sydney.edu.au A study report will be available from the PI on re... [More Details]
19573Ethical approval  edel.ohagan@sydney.edu.au Ethical approval will be available from the PI on ... [More Details]



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.