ANZCTR - Registration

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypertension

Condition category

Condition code

Cardiovascular

Hypertension

Public Health

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]

Early detection / Screening

Intervention code [2]

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]

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]

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]

Net difference in change in systolic BP (mmHg) from baseline to last repeat measurement on a SiSU station

Timepoint [1]

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]

Net difference in change in diastolic BP (mmHg) from baseline to last repeat measurement on a SiSU station

Timepoint [2]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

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]

2640 - Albury

Recruitment postcode(s) [2]

2148 - Blacktown

Recruitment postcode(s) [3]

2350 - Armidale

Recruitment postcode(s) [4]

2795 - Bathurst

Recruitment postcode(s) [5]

2560 - Campbelltown

Recruitment postcode(s) [6]

2450 - Coffs Harbour

Recruitment postcode(s) [7]

2830 - Dubbo

Recruitment postcode(s) [8]

2871 - Forbes

Recruitment postcode(s) [9]

2428 - Forster

Recruitment postcode(s) [10]

2580 - Goulburn

Recruitment postcode(s) [11]

2460 - Grafton

Recruitment postcode(s) [12]

2680 - Griffith

Recruitment postcode(s) [13]

2526 - Kembla Grange

Recruitment postcode(s) [14]

2440 - Kempsey

Recruitment postcode(s) [15]

2480 - Lismore

Recruitment postcode(s) [16]

2541 - Nowra

Recruitment postcode(s) [17]

2211 - Padstow

Recruitment postcode(s) [18]

2750 - Penrith

Recruitment postcode(s) [19]

2444 - Port Macquarie

Recruitment postcode(s) [20]

2164 - Smithfield

Recruitment postcode(s) [21]

2340 - Tamworth

Recruitment postcode(s) [22]

2163 - Villawood

Recruitment postcode(s) [23]

2650 - Wagga Wagga

Recruitment postcode(s) [24]

2015 - Alexandria

Recruitment postcode(s) [25]

2067 - Chatswood

Recruitment postcode(s) [26]

2777 - Valley Heights

Recruitment postcode(s) [27]

2170 - Casula

Recruitment postcode(s) [28]

2284 - Boolaroo

Recruitment postcode(s) [29]

2527 - Albion Park Rail

Recruitment postcode(s) [30]

2390 - Narrabri

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Country [2]

Australia

Primary sponsor type

Other

Name

The George Institute for Global Health

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Reserach Ethics & Compliance Support

Ethics committee address [1]

Research Ethics & Compliance Support, Level 3. Rupert Myers Building South Wing (M15), UNSW Kensington Campus, NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/07/2023

Approval date [1]

26/09/2023

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Prof Aletta Schutte

Address

Level 18, The George Institute for Global Health, International Towers 3, 300 Barangaroo NSW 2000

Country

Australia

Phone

+61 450 315 918

Email

[email protected]

Contact person for public queries

Name

Aletta Schutte

Address

Level 18, The George Institute for Global Health, International Towers 3, 300 Barangaroo NSW 2000

Country

Australia

Phone

+61 450 315 918

Email

[email protected]

Contact person for scientific queries

Name

Aletta Schutte

Address

Level 18, The George Institute for Global Health, International Towers 3, 300 Barangaroo NSW 2000

Country

Australia

Phone

+61 450 315 918

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically