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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.
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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
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Secondary ID [1]
310004
0
Nil known
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Universal Trial Number (UTN)
Nil known
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Trial acronym
CHeCCK
(Consumer-led Hypertension Care in Community-based Kiosks)
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
330511
0
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Condition category
Condition code
Cardiovascular
327358
327358
0
0
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Hypertension
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Public Health
327495
327495
0
0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326430
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Prevention
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Comparator / control treatment
Participants in the control group will receive an email from SiSU Health with specific, actionable advice only.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
335227
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Timepoint [1]
335227
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Once during the period 30-45 days post randomisation
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Secondary outcome [1]
423554
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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.
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Assessment method [1]
423554
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Timepoint [1]
423554
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Once during the period 30-45 days post randomisation
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Secondary outcome [2]
423555
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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.
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Assessment method [2]
423555
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Timepoint [2]
423555
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Once during the period 30-45 days post randomisation
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Secondary outcome [3]
423556
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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.
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Assessment method [3]
423556
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Timepoint [3]
423556
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Once during the period 30-45 days post randomisation
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Secondary outcome [4]
423557
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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.
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Assessment method [4]
423557
0
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Timepoint [4]
423557
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Once during the period 30-45 days post randomisation
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Secondary outcome [5]
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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.
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Assessment method [5]
424049
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Timepoint [5]
424049
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30-45 days post randomisation
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Secondary outcome [6]
424051
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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.
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Assessment method [6]
424051
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Timepoint [6]
424051
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Once during the period 30-45 days post randomisation
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Secondary outcome [7]
424052
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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.
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Assessment method [7]
424052
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Timepoint [7]
424052
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Once during the period 30-45 days post randomisation
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Secondary outcome [8]
424053
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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.
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Assessment method [8]
424053
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Timepoint [8]
424053
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Once during the period 30-45 days post randomisation
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Do not consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
N/A
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2023
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Actual
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Date of last participant enrolment
Anticipated
31/10/2023
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Actual
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Date of last data collection
Anticipated
30/11/2023
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Actual
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Sample size
Target
906
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
314181
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Other Collaborative groups
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Name [1]
314181
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Digital Health CRC
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Address [1]
314181
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Suite 7.04, Level 7,
3 Spring Street, Sydney
NSW, 2000
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Country [1]
314181
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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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
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Country
Australia
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Secondary sponsor category [1]
316098
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None
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Name [1]
316098
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Address [1]
316098
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Country [1]
316098
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Other collaborator category [1]
282744
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Commercial sector/Industry
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Name [1]
282744
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SiSU Health
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Address [1]
282744
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442 Auburn Road, Hawthorn, Victoria, 3122
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Country [1]
282744
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
313309
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
313309
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Level 3, Michael Spence Building (F23), University of Sydney, NSW, 2006
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Ethics committee country [1]
313309
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Australia
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Date submitted for ethics approval [1]
313309
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26/06/2023
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Approval date [1]
313309
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Ethics approval number [1]
313309
0
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Summary
Brief summary
The CHeCCK study proposes to improve the pathway to care for people who record a high blood pressure at a self-check health station within the community. We propose to achieve this through the combination of two proven detection and health education methods. SiSU health check stations are located within Priceline pharmacies throughout Australia and have detected hundreds of thousands of Australians who recorded a high blood pressure reading. Combined with a text message-based health education program, previously clinically proven to improve health risk factors and be highly acceptable to the general public.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Edel O'Hagan
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Address
127686
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Westmead Applied Research Centre, Faculty of Medicine and Health,
The University of Sydney,
Level 5, Entrance 10,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
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Country
127686
0
Australia
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Phone
127686
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+61404474715
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Fax
127686
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Email
127686
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[email protected]
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Contact person for public queries
Name
127687
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Edel O'Hagan
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Address
127687
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Westmead Applied Research Centre, Faculty of Medicine and Health,
The University of Sydney,
Level 5, Entrance 10,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
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Country
127687
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Australia
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Phone
127687
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+61404474715
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Fax
127687
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Email
127687
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[email protected]
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Contact person for scientific queries
Name
127688
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Edel O'Hagan
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Address
127688
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Westmead Applied Research Centre, Faculty of Medicine and Health,
The University of Sydney,
Level 5, Entrance 10,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
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Country
127688
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Australia
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Phone
127688
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+61404474715
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Fax
127688
0
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Email
127688
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19570
Study protocol
[email protected]
We intend to publish the protocol in a peer review...
[
More Details
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19571
Statistical analysis plan
We will upload the SAP to a data sharing platform ...
[
More Details
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19572
Clinical study report
[email protected]
A study report will be available from the PI on re...
[
More Details
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19573
Ethical approval
[email protected]
Ethical approval will be available from the PI on ...
[
More Details
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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.
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