Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000836437
Ethics application status
Approved
Date submitted
7/07/2025
Date registered
4/08/2025
Date last updated
4/08/2025
Date data sharing statement initially provided
4/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a primary care domestic and family violence intervention on Women's Emotional Well-Being (the WEB Project)
Scientific title
Investigating the effect of a primary care domestic and family violence intervention to improve Women's Emotional Well-Being (the WEB Project)
Secondary ID [1] 314517 0
None
Universal Trial Number (UTN)
Trial acronym
WEB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Domestic and family violence 337600 0
Condition category
Condition code
Public Health 333944 333944 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The WEB intervention is a novel model of care for women who report feeling afraid of a partner/ex-partner and/or family member in the last 12 months. All participating clinicians will be trained in addressing domestic and family violence. This will be completed at least 4 weeks prior to the first clinic randomisation at each wave (3 waves in total). Training will total 7.5 hours, including 90 mins x 3 online learning modules, reading 90 mins and workshops x 2 for 90 mins delivered online by a general practitioner (GP) and domestic and family violence worker. Eligible women who are randomised to the intervention arm will be offered a funded 30 minute appointment to provide a first line response including a family safety assessment and safety plan (based on standard Victorian government recommended safety assessment and planning) using a Clinical Decision Support System, developed for this study. During this appointment, women will be offered a referral for six one hour consultations with a trained peer support worker over a six-month period, in person or remotely. The peer support workers will be women who have experienced domestic and family violence (DFV) who have previously navigated the service system. They will be recruited and trained at least two weeks before first clinic randomisation, through a series of 4 x 5 hour workshops delivered in person. Training will include outline of peer support sessions, enhancing communication skills and boundary setting, safety issues, services available in the area and worker well-being. The peer support workers will be supported by a local DFV worker. GP/nurses and peer support workers will keep attendance and session checklists. GPs/nurses in the intervention arm will receive one rebate payment of $100 (similar to health assessment item numbers) for each assessment/patient/year. Eligible women will also be offered ongoing support by the GP/nurse and referrals to DFV services as needed. Overall duration of the study will be 3 years post first clinic randomisation.
Intervention code [1] 331147 0
Treatment: Other
Comparator / control treatment
Women who are randomised to the comparison arm will receive standard care from their GP/nurse (15-30 minutes appointment if they wish to attend) and a resource list of services.
Control group
Active

Outcomes
Primary outcome [1] 341592 0
Distress symptoms
Timepoint [1] 341592 0
Baseline and 12 months post randomisation
Secondary outcome [1] 448006 0
Referrals that are helpful
Timepoint [1] 448006 0
Baseline and 6 months post randomisation
Secondary outcome [2] 448260 0
Safety and well-being related empowerment composite
Timepoint [2] 448260 0
Baseline and 12 months post randomisation
Secondary outcome [3] 448261 0
Sense of safety
Timepoint [3] 448261 0
Baseline, 6 and 12 months post randomisation
Secondary outcome [4] 448262 0
Sense of support by GP/nurse
Timepoint [4] 448262 0
Baseline and 6 months post randomisation
Secondary outcome [5] 449105 0
Cost effectiveness
Timepoint [5] 449105 0
Baseline and 12 months post randomisation

Eligibility
Key inclusion criteria
General practices with three or more general practitioners or nurses willing to participate. Clinics will have Medical Director or Best Practice software and >1500 active patients.

Woman or trans women aged 18 years or older who have visited the participating clinci at least once in the last 12 months and experienced fear of partner, ex-partner and/or family member in the last 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
n/a

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 was concealed as it will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
GP practices will be randomly allocated 1:1 to intervention and control group using a random allocation sequence computer-generated by an independent statistician stratified by urban or rural location of the practice, with permuted block of random sizes within each stratum. To ensure concealment, the block size will be disclosed until after all the general practices have been randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
We require 24 clinics with 864 (36 per clinic) women at baseline to detect a standardised effect size of 0.3 in difference in mean distress at 12 months (primary outcome) between intervention and control groups for 80% power at a significance level of 5% for a two-sided test, allowing for an intra-cluster correlation of 0.02 and a 25% attrition in women at 12 months based on other primary care trials. A 0.3 standardised effect size is equivalent to a between-group difference in means of 4.7 on DASS-21, given standard deviation in clinical sample is 15.7. We have included four additional clinics to allow for clinics withdrawing/closing during trial and to accommodate the t-distribution in the analysis. Sample size is feasible based on previous research, where we expect 1,500 women to be active patients, of whom 10% would meet eligibility criteria, 48% agree to come into the Project.

Descriptive statistics will be used to summarise general practice characteristics and baseline participant characteristics and measures by the two study groups and overall. Means and standard deviations (or percentiles) will be used for continuous data, and frequencies and percentages for categorical data. Primary analysis will use an intention-to-treat (ITT) strategy, where all participants will be analysed in the study group that the general practice was assigned. Linear mixed effects regression model will be used to estimate the difference in mean distress at 12 months (primary outcome) between the intervention and control arms, adjusted for distress measured at baseline and location used to stratify randomisation. General practices will be treated as random effects to account for correlated outcomes within general practices. Similar regression analysis will be conducted for secondary continuous outcomes. Estimated intervention effects will be reported as differences in mean outcome between groups at each follow-up time point with 95% confidence intervals and p-values. A blinded review will inform the approach for accounting for missing outcomes. Sensitivity analysis to assess the robustness of the missing data and other supplementary analyses, including adjustment of pre-specified confounders (e.g. children vs no children), analysis that account for non-compliance with the uptake of intervention and sub-group analysis will be detailed in a statistical analysis plan.

For the economic evaluation, resource use data from self-reported questionnaires and Medicare data and will be valued at standard unit cost rates to estimate intervention delivery costs and impact of the intervention on costs of access/use and service use over the six months from the perspective of (i) government and (ii) women. Economic evaluation will, as a first step, present a cost-consequences analysis with costs presented separately for government and women compared with the difference in all outcome measures. If a significant difference in help-seeking is found, cost-effectiveness analysis against the primary outcome will then be presented.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319060 0
Government body
Name [1] 319060 0
Australian Government Department of Health and Ageing MRFF
Country [1] 319060 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321524 0
None
Name [1] 321524 0
Address [1] 321524 0
Country [1] 321524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317662 0
Science, Technology, Engineering, Mathematics and Medicine (STEMM 1)- Greater Than Low Risk (GTLR) committee
Ethics committee address [1] 317662 0
Ethics committee country [1] 317662 0
Australia
Date submitted for ethics approval [1] 317662 0
09/04/2025
Approval date [1] 317662 0
06/06/2025
Ethics approval number [1] 317662 0
31084

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

Contacts
Principal investigator
Name 141742 0
Prof Kelsey Hegarty
Address 141742 0
Department of General Practice and Primary Care, Melbourne Medical School, Level 3 North Wing, Building 181 Grattan Street, The University of Melbourne, Victoria 3010
Country 141742 0
Australia
Phone 141742 0
+61 3 8344 4992
Fax 141742 0
Email 141742 0
[email protected]
Contact person for public queries
Name 141743 0
Fiona Giles
Address 141743 0
Department of General Practice and Primary Care, Melbourne Medical School, Level 3 North Wing, Building 181 Grattan Street, The University of Melbourne, Victoria 3010
Country 141743 0
Australia
Phone 141743 0
+61 3 8344 4992
Fax 141743 0
Email 141743 0
[email protected]
Contact person for scientific queries
Name 141744 0
Fiona Giles
Address 141744 0
Department of General Practice and Primary Care, Melbourne Medical School, Level 3 North Wing, Building 181 Grattan Street, The University of Melbourne, Victoria 3010
Country 141744 0
Australia
Phone 141744 0
+61 3 8344 4992
Fax 141744 0
Email 141744 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.