Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001740886
Ethics application status
Approved
Date submitted
27/10/2021
Date registered
20/12/2021
Date last updated
20/12/2021
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Hairdressers for Health: The effect of an education intervention conducted in NSW hairdressing salons on the uptake of the Heart Health Check.
Scientific title
Hairdressers for heart health: The effect of a nudge intervention to improve uptake of the Heart Health Check in women attending NSW hairdressing salons.
Secondary ID [1] 305558 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 324045 0
Condition category
Condition code
Cardiovascular 321552 321552 0 0
Coronary heart disease
Public Health 321822 321822 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Salon staff will direct their clients aged 45 years or older to a QR code which opens the study website. The decision to engage with the QR code and study website is entirely at the discretion of the potential participant. Intervention participants will be given online and printed generic women’s health advice and targeted cardiovascular (CV) risk materials designed specifically for this study at baseline comprising:
• Information about cardiovascular disease risk factors in women and the importance of a formal CV risk assessment and specific advice to book a Heart Health Check with their general practitioner. The materials will take approximately 5 minutes to read through.
• A letter for their general practitioner that promotes a formal Heart Health Check using the Medicare item number if appropriate.
The study will conducted in each salon until 27 participants have been recruited or 12 months from recruitment start date has passed (whichever occurs first).
After participants have consented and scrolled through the study materials, they will progress through the website to view a health questionnaire. Participants that complete the questionnaire will have viewed the study materials.
Intervention code [1] 322017 0
Prevention
Intervention code [2] 322018 0
Early detection / Screening
Comparator / control treatment
Salon staff will direct their clients aged 45 years or older to a QR code which opens the study website. The decision to engage with the QR code and study website is entirely at the discretion of the potential participant. Control participants will be provided with online and printed information sheet with general women’s health advice that is not specific to CV disease. The information sheet was designed specifically for this study. This will include national recommended breast screening safe alcohol intake levels and promotion of an active lifestyle and mental health. It will not mention the Heart Health Check. The materials will take approximately 2 minutes to read through.
After participants have consented and scrolled through the study materials, they will progress through the website to view a health questionnaire. Participants that complete the questionnaire will have viewed the study materials.
Control group
Active

Outcomes
Primary outcome [1] 329321 0
The proportion of women who have had a Heart Health Check within 6 months following randomisation, assessed by linkage of the study cohort to the Medical Benefits Schedule (MBS).
Timepoint [1] 329321 0
6 months post intervention commencement
Secondary outcome [1] 402117 0
A self-reported new diagnosis of a CV risk factor collected via a study-specific questionnaire emailed to participants.
Timepoint [1] 402117 0
6 months post intervention commencement
Secondary outcome [2] 402118 0
A self-reported new diagnosis of CV disease collected via a study-specific questionnaire emailed to participants.
Timepoint [2] 402118 0
6 months post intervention commencement
Secondary outcome [3] 402119 0
A self-reported GP review that included discussion of CV risk factors or risk factor review (but not claimed as Heart Health Check) collected via a study-specific questionnaire emailed to participants.
Timepoint [3] 402119 0
6 months post intervention commencement
Secondary outcome [4] 402120 0
Self-reported tobacco cessation collected via a study-specific questionnaire emailed to participants.
Timepoint [4] 402120 0
6 months post intervention commencement
Secondary outcome [5] 402121 0
Self-reported physical activity levels based on number of hours exercised per week collected via a study-specific questionnaire emailed to participants.
Timepoint [5] 402121 0
6 months post intervention commencement
Secondary outcome [6] 402122 0
Health-related quality-of-life using the EuroQol - 5 Level - 5 Dimension (EQ-5D-5L) questionnaire emailed to participants.
Timepoint [6] 402122 0
6 months post intervention commencement
Secondary outcome [7] 402123 0
New CV medication (blood pressure, cholesterol or glucose lowering, antiplatelet) prescribed in the period 6 months following the intervention and not in the period 12 months pre-intervention as assessed by linkage the the PBS dataset.
Timepoint [7] 402123 0
6 months post intervention commencement
Secondary outcome [8] 402124 0
Mammography undertaken by women at 6 months as assessed by linkage the MBS dataset.
Timepoint [8] 402124 0
6 months post intervention commencement
Secondary outcome [9] 402125 0
Cervical cancer screening undertaken by women at 6 months as assessed by linkage the MBS dataset.
Timepoint [9] 402125 0
6 months post intervention commencement
Secondary outcome [10] 402126 0
The number and description of all visits to GP/ Specialist medical professional at 6 months as assessed by linkage the MBS dataset.
Timepoint [10] 402126 0
6 months post intervention commencement

Eligibility
Key inclusion criteria
1. Women aged greater than or equal to 45 years attending a hairdressing salon
2. Able to provide online informed consent
Minimum age
45 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be ineligible if they plan to leave Australia within the trial follow-up period of 6 months.

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)
This study is a double-blind cluster randomised controlled trial where hair salons will be randomised to either the intervention or control arm. The web-based randomisation system will conceal the randomisation allocated to the salon. Study participants will thus be blinded to salon allocation and participant allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Enrolled salons will be allocated using a computer-generated randomisation algorithm 1:1 to intervention or control, stratified by salon SEIFA score. The allocation sequence will be generated by the system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Power
The sample size of 60 groups (salons) per randomisation strategy with 27 participants per group will provide 80% power (2 alpha=0.05) with an intra-class correlation of 0.1 to detect a 5% absolute difference in the primary outcome between randomised groups. This assumes a 5% background rate of Heart Health Check uptake in the control group, and a 5% absolute increase in women screened with the intervention.

Statistical Analysis
The primary intention-to-treat analyses will use a hierarchical log-binomial regression model with salon as a cluster random effect to estimate relative risks and 95% confidence intervals. Pre-specified subgroup analyses will assess effects by SEIFA decile (at a cluster level) and age and whether or not English is the first language (at an individual level). Imputation for missing data is not anticipated to be required for data linkage outcomes but may be done for self-reported data if significant missing data identified during the blind review.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
31/01/2023
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
3240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309924 0
Government body
Name [1] 309924 0
NHMRC
Country [1] 309924 0
Australia
Funding source category [2] 309978 0
Charities/Societies/Foundations
Name [2] 309978 0
Faye Williams Estate
Country [2] 309978 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King St
Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 311085 0
None
Name [1] 311085 0
Address [1] 311085 0
Country [1] 311085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309642 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 309642 0
UNSW Sydney NSW 2052
Ethics committee country [1] 309642 0
Australia
Date submitted for ethics approval [1] 309642 0
02/08/2021
Approval date [1] 309642 0
15/10/2021
Ethics approval number [1] 309642 0

Summary
Brief summary
Australian women have high rates of poorly controlled cardiovascular risk factors. In turn, cardiovascular (CV) disease is responsible for the death of 22 women every day in Australia. The ‘Heart Health Check’ is an MBS item number allowing general practitioners to be reimbursed for performing a formal CV risk assessment on a patient. Currently only around 1.1% of eligible NSW women have a formal ‘Heart Health Check’ each year with their GP.

This study aims to understand the value of promoting CV risk assessment outside traditional health care settings among female attendees of NSW hairdressing salons.

The researchers hypothesise that the intervention will:
(i) Increase the proportion of women having a Medicare-rebated Heart Health Check;
(ii) Increase the proportion with at-risk levels of cardiovascular risk factors identified; and
(iii) Increase the use of medications for cardiovascular risk management
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114878 0
Dr Clare Arnott
Address 114878 0
The George Institute for Global Health
Level 5, 1 King St
Newtown NSW 2042
Country 114878 0
Australia
Phone 114878 0
+61280524823
Fax 114878 0
Email 114878 0
carnott@georgeinstitute.org.au
Contact person for public queries
Name 114879 0
Dr Clare Arnott
Address 114879 0
The George Institute for Global Health
Level 5, 1 King St
Newtown NSW 2042
Country 114879 0
Australia
Phone 114879 0
+61280524823
Fax 114879 0
Email 114879 0
carnott@georgeinstitute.org.au
Contact person for scientific queries
Name 114880 0
Dr Clare Arnott
Address 114880 0
The George Institute for Global Health
Level 5, 1 King St
Newtown NSW 2042
Country 114880 0
Australia
Phone 114880 0
+61280524823
Fax 114880 0
Email 114880 0
carnott@georgeinstitute.org.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
13697Ethical approval  knallaiah@georgeinstitute.org.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.