Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001022651
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
20/09/2023
Date last updated
10/12/2023
Date data sharing statement initially provided
20/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Shop-to-Stop Hypertension: A public screening campaign to detect and manage raised blood pressure in Australian adults
Scientific title
Shop-to-Stop Hypertension: A single-blind multicentre cluster-randomised trial of adults screened with high blood pressure in health kiosks at retail stores delivering text messages to encourage blood pressure rechecks and primary care visits
Secondary ID [1] 310467 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 331262 0
Condition category
Condition code
Cardiovascular 328016 328016 0 0
Hypertension
Public Health 328226 328226 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants screened and detected with high blood pressure (greater than or equal to 140/90 mmHg) at a SiSU (registered brand name) Health kiosk Station in Bunnings will receive text message-based nudges to a) return for a repeat SiSU Health Station blood pressure check b) visit their GP to check and manage their blood pressure and c) improve their self-care. Participants will have new data captured at each visit they attend a SiSU Health Station over the 12 month study period (study period is defined as 12 months from the date the SiSU Health Station is 'active' for data collection). Although participants are encouraged to attend for a re-check at a SiSU Health Station, this is not a requirement of study participation.

Along with blood pressure measures, SiSU health Stations will also be measuring: weight and height (which automatically calculates BMI), body composition, and heart rate, Each visit will take approximately 5-10 minutes to complete. Participants will be able to independently and accurately measure blood pressure without the need for supervision or assistance of other study members. Additionally, no assistance will be required for participants to complete the questions or health measures at the Health Stations.

Participants are nudged to go to their general practitioner for further evaluation and management via text messages.. These will be automatically sent using SiSU's text message delivery systems incorporated into the Health Stations that can track delivery of the messages. Messages will be sent to participants at 1 week, 2 weeks and 12 weeks post their initial screening. Messages have been co-designed specifically for this study by consumers, clinicians, and investigators who are experts in messaging design . There are no other readily-available resources for this study.

Text message content include:
* Encouragement for a recheck of blood pressure at week 1: 'you recorded high blood pressure at the Bunnings health check station. High blood pressure increases your risk of stroke and heart attack. To understand if your blood pressure needs treatment, Cardiologists and heart health researchers at The University of New South Wales would like to remind you to re-check your blood pressure often, ideally within the next 7 days at Bunnings.',
* Improve self-care at week 2: 'It is important to check in and have your blood pressure re-checked often. If you have high blood pressure, visit your doctor who can recommend diet and lifestyle changes or treatment options that are effective. Since your first visit, have you re-checked your blood pressure at a SiSU health station at Bunnings again?'
* Return for follow up at week 12: 'Blood pressure levels can change over time. To prevent a stroke or heart attack, it’s a good idea to have your blood pressure rechecked this week at a SiSU health station in Bunnings. Have you visited your doctor since you recorded a high blood pressure?'

All participants (regardless of blood pressure levels) will also receive an email message after their screening to provide their health check results (including blood pressure) and a link to download the SiSU Health phone app with encouragement to adopt a healthy lifestyle.

Adherence to the requests will be captured either at a follow up SiSU health station recheck, response to questions on the kiosk on whether they’ve visited their GP recently, and in response to the questions from the text message nudges.
Intervention code [1] 326861 0
Early detection / Screening
Intervention code [2] 326862 0
Behaviour
Comparator / control treatment
Participants with high blood pressure will continue as usual outlined below (i.e., no text message nudge).
All participants screened at a SiSU health station in the control group will receive a standard SiSU email message after their screening. This email includes their health check results (including blood pressure) and a link for them to download the SiSU Health phone app with encouragement to adopt a healthy lifestyle. All participants screened with an elevated blood pressure will receive a recommendation to visit their GP on the health station. Participants with a very high (160-179/100-109 mmHg) or severely high (180/110+ mmHg) blood pressure will also receive an automated email alert afterwards explaining the readings and recommending re-checking their blood pressure and recommendation to visit their doctor
Control group
Active

Outcomes
Primary outcome [1] 335885 0
Difference in the proportion of participants with high BP detected at a SiSU health station, having a repeat BP check at a SiSU health station in the intervention compared to the control group. All data is automatically captured by the health stations to determine repeat attendees and will be accessed by the investigator team in a de-identified format for analysis.
Timepoint [1] 335885 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection ) a participant with high blood pressure returns for more than one blood pressure reading at a SiSU health station
Secondary outcome [1] 425982 0
Net difference in change in systolic BP (mmHg) from baseline to last repeat measurement on a SiSU station
Timepoint [1] 425982 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last BP measure on a SiSU health station
Secondary outcome [2] 425983 0
Net difference in change in diastolic BP (mmHg) from baseline to last repeat measurement on a SiSU station
Timepoint [2] 425983 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last BP measure on a SiSU health station
Secondary outcome [3] 425984 0
The percentage of participants achieving target BP (<140/<90 mmHg). All data is automatically captured by the SiSU health stations and will be accessed by the investigator team in a de-identified format for analysis.
Timepoint [3] 425984 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last BP measure on a SiSU health station
Secondary outcome [4] 425985 0
Net difference in change in weight in participants with repeated health checks. All data is automatically captured by the SiSU health stations and will be accessed by the investigator team in a de-identified format for analysis.
Timepoint [4] 425985 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last SiSU health station check
Secondary outcome [5] 425986 0
Net difference in change in BMI (automatically calculated and captured by SiSU health stations using height and weight data) in participants with repeated health station checks. Data will be accessed by the investigator team in a de-identified format for analysis
Timepoint [5] 425986 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last health check on a SiSU health station
Secondary outcome [6] 425987 0
Net difference in change in body fat percentage (automatically captured by SiSU health stations) in participants with repeated health station checks. All data will be accessed by the investigator team in a de-identified format for analysis
Timepoint [6] 425987 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last health check on a SiSU health station
Secondary outcome [7] 425988 0
Net difference in use of BP medications based on answers in the self-reported questionnaire captured by the SiSU Health Station in participants with repeated SiSU Health Station visits. All data is automatically captured by the health stations and will be accessed by the investigator team in a de-identified format for analysis
Timepoint [7] 425988 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their last BP measure on a SiSU health station
Secondary outcome [8] 425989 0
Net difference in change in health risk behaviours (e.g., smoking, exercise and dietary practices) based on answers in the self-reported questionnaire captured by the SiSU Health Station in participants with repeated SiSU Health Station visits. All data is automatically captured by the health stations and will be accessed by the investigator team in a de-identified format for analysis
Timepoint [8] 425989 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for their health checks on a SiSU health station
Secondary outcome [9] 425990 0
Self-reported medical attendance (whether they saw their GP for high BP) based on answers in the self-reported questionnaire captured by the SiSU Health Station as well as from analytics from the responses to the text message nudges. All data is automatically captured by the health stations and will be accessed by the investigator team in a de-identified format for analysis
Timepoint [9] 425990 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant returns for a BP measure on a SiSU health station
Secondary outcome [10] 425991 0
Number of BP checks captured by analytics of number of repeated visits per participant to the SiSU health stations. All data is automatically captured by the health stations and will be accessed by the investigator team in a de-identified format for analysis.
Timepoint [10] 425991 0
At any stage during the 12 month study period (based on a 12 month period from the day the SiSU Health Station was made 'active' to begin data collection) a participant attends the SiSU health station for a BP check

Eligibility
Key inclusion criteria
Aged 18 years and older
Provided electronic consent to participate in the trial
Willing to use SiSU health station to undergo health and BP check at Bunnings in NSW
Willing to provide a valid personal mobile phone number
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to perform a SiSU health station check

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 concealed by computer generated randomisation of sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation - the 30 Bunnings stores stratified by Socio-Economic Indexes for Areas (SEIFA) and location, ensuring an equal number of metropolitan, rural and remote sites in each arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on current SISU use, we anticipate an average of 15 checks per station per operating day (conservative estimate). We target an average of 2.5 checks per participant per annum, equating to 163,350 total checks and 65,340 total participants. Assuming that 18% of those screened will have high BP (based on previous pilot data of two SiSU stations in Bunnings stores), this will equate to 11,700 people detected with raised BP.
A parallel two-group cluster-randomised design will be used to test whether the Group 1 (text message intervention) proportion (P1) is different from the Group 2 (control) proportion (P2) (H0: P1 - P2 = 0 versus H1: P1 - P2 does not equal 0). The comparison will be made using a two-sided Z-Test (Unpooled) based on the proportion difference, with a Type I error rate (a) of 0.05. The control group proportion (P2) is assumed to be 0.2. Recruiting 11,700 participants and assuming 70% drop out, results in 3,510 randomised participants completing follow-up. For a power of 90% with 15 clusters of 117 participants per cluster in Group 1 and 15 clusters of 117 subjects per cluster in Group 2, the detectable proportion difference (P1 - P2) is 0.085 (or P1 of 0.285). The intra-cluster correlation coefficient assumed is 0.02. That is, this trial will achieve 90% power to detect an 8.5% difference in the proportion of participants returning for a SiSU health station check. The detectable proportion difference (P1 - P2) was computed using PASS 2023, version 23.0.1.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
4/12/2023
Date of last participant enrolment
Anticipated
14/12/2024
Actual
Date of last data collection
Anticipated
14/12/2024
Actual
Sample size
Target
65340
Accrual to date
142
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41237 0
2015 - Alexandria
Recruitment postcode(s) [2] 41238 0
2067 - Chatswood
Recruitment postcode(s) [3] 41206 0
2148 - Blacktown
Recruitment postcode(s) [4] 41233 0
2163 - Villawood
Recruitment postcode(s) [5] 41231 0
2164 - Smithfield
Recruitment postcode(s) [6] 41240 0
2170 - Casula
Recruitment postcode(s) [7] 41226 0
2211 - Padstow
Recruitment postcode(s) [8] 41241 0
2284 - Boolaroo
Recruitment postcode(s) [9] 41232 0
2340 - Tamworth
Recruitment postcode(s) [10] 41207 0
2350 - Armidale
Recruitment postcode(s) [11] 41773 0
2390 - Narrabri
Recruitment postcode(s) [12] 41214 0
2428 - Forster
Recruitment postcode(s) [13] 41222 0
2440 - Kempsey
Recruitment postcode(s) [14] 41228 0
2444 - Port Macquarie
Recruitment postcode(s) [15] 41210 0
2450 - Coffs Harbour
Recruitment postcode(s) [16] 41218 0
2460 - Grafton
Recruitment postcode(s) [17] 41223 0
2480 - Lismore
Recruitment postcode(s) [18] 41221 0
2526 - Kembla Grange
Recruitment postcode(s) [19] 41242 0
2527 - Albion Park Rail
Recruitment postcode(s) [20] 41225 0
2541 - Nowra
Recruitment postcode(s) [21] 41209 0
2560 - Campbelltown
Recruitment postcode(s) [22] 41217 0
2580 - Goulburn
Recruitment postcode(s) [23] 41202 0
2640 - Albury
Recruitment postcode(s) [24] 41234 0
2650 - Wagga Wagga
Recruitment postcode(s) [25] 41219 0
2680 - Griffith
Recruitment postcode(s) [26] 41227 0
2750 - Penrith
Recruitment postcode(s) [27] 41239 0
2777 - Valley Heights
Recruitment postcode(s) [28] 41208 0
2795 - Bathurst
Recruitment postcode(s) [29] 41212 0
2830 - Dubbo
Recruitment postcode(s) [30] 41213 0
2871 - Forbes

Funding & Sponsors
Funding source category [1] 314671 0
Government body
Name [1] 314671 0
NSW Health
Country [1] 314671 0
Australia
Funding source category [2] 314679 0
Government body
Name [2] 314679 0
National Health and Medical Research Council
Country [2] 314679 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King StreetNewtown, NSW 2042
Country
Australia
Secondary sponsor category [1] 316645 0
None
Name [1] 316645 0
Address [1] 316645 0
Country [1] 316645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313690 0
University of New South Wales Reserach Ethics & Compliance Support
Ethics committee address [1] 313690 0
Research Ethics & Compliance Support, Level 3. Rupert Myers Building South Wing (M15), UNSW Kensington Campus, NSW 2052
Ethics committee country [1] 313690 0
Australia
Date submitted for ethics approval [1] 313690 0
31/07/2023
Approval date [1] 313690 0
26/09/2023
Ethics approval number [1] 313690 0
HC230508

Summary
Brief summary
Aim: The study is testing a novel way to improve awareness and detection of raised blood pressure in Australia by screening customers and/or the workforce of Bunnings Warehouse for raised blood pressure and related health markers on SiSU Health Stations. The aim is to to identify, refer and follow adults in need of hypertension care, whilst raising population-wide awareness. In a randomised control trial, we will determine in participants with detected high BP at a SiSU health station in Bunnings, whether text message-based nudges encouraging repeat BP checks at the SiSU health station and to visit their GP, compared to those not receiving text messages, will result in a greater proportion of participants to recheck their BP at a SiSU health station over the course of 12 months. Secondary outcomes include identifying change in BP, weight, body mass index, body fat percentage, and use of BP medications in people who visit SiSU health stations more than once.
Hypothesis: text message-based nudges will be superior to control in terms of promoting repeat BP checks in adults detected with high BP at SiSU health stations at Bunnings warehouses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129026 0
Prof Aletta Schutte
Address 129026 0
Level 18, The George Institute for Global Health, International Towers 3, 300 Barangaroo NSW 2000
Country 129026 0
Australia
Phone 129026 0
+61 450 315 918
Fax 129026 0
Email 129026 0
a.schutte@unsw.edu.au
Contact person for public queries
Name 129027 0
Prof Aletta Schutte
Address 129027 0
Level 18, The George Institute for Global Health, International Towers 3, 300 Barangaroo NSW 2000
Country 129027 0
Australia
Phone 129027 0
+61 450 315 918
Fax 129027 0
Email 129027 0
a.schutte@unsw.edu.au
Contact person for scientific queries
Name 129028 0
Prof Aletta Schutte
Address 129028 0
Level 18, The George Institute for Global Health, International Towers 3, 300 Barangaroo NSW 2000
Country 129028 0
Australia
Phone 129028 0
+61 450 315 918
Fax 129028 0
Email 129028 0
a.schutte@unsw.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.