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Trial registered on ANZCTR


Registration number
ACTRN12614001306606
Ethics application status
Approved
Date submitted
8/12/2014
Date registered
15/12/2014
Date last updated
3/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an online healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE)
Scientific title
I-DECIDE: A trial to determine whether an online intervention encouraging users to self-inform, self-reflect and self-manage can increase self-efficacy and reduce depressive symptoms in women who have experienced fear of a partner and/or partner abuse in the past 6 months compared to a standard website.
Secondary ID [1] 285629 0
NIL
Universal Trial Number (UTN)
U1111-1163-8828
Trial acronym
I-DECIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Domestic Violence 293580 0
Intimate Partner Abuse 293672 0
Condition category
Condition code
Mental Health 293864 293864 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will complete a brief screening questionnaire to determine eligibility (age 16-50, female, experienced fear of a partner and/or emotional, sexual or physical violence over the past 6 months). Eligible women randomised to the intervention group will be emailed to confirm their participation in the study, and will receive the link to the intervention website. After logging in and completing the introductory study questions, women will proceed to the intervention home page, which consists of three modules, focusing on relationship health, safety, and weighing up priorities for their relationship. The modules contain questions and exercises to encourage reflection and raise awareness. On completion of these modules, women who indicate that they are unaware of being in an unhealthy relationship will be directed to a motivational interviewing exercise designed to help them reflect on the positives and negatives of the relationship. Women who have a greater level of awareness will not complete this module. Women will then proceed to the "Action Plan" which is an individualised list of strategies for safety and wellbeing tailored to the woman's priorities, level of danger, and whether or not she has children. She can explore a longer list of all available strategies if she wants more information or does not like the ones selected for her. The final step is a goal-setting exercise where women are invited to workshop a chosen strategy by exploring the options available to help them enact it, and the pros and cons for each. The overall aim of the intervention is for women to self-reflect, self-inform and self-manage in a safe and private space. The website on average will taken women around 30 minutes to complete.
Intervention code [1] 290659 0
Treatment: Other
Intervention code [2] 290660 0
Behaviour
Comparator / control treatment
Women will complete a brief screening questionnaire to determine eligibility (age 16-50, female, experienced fear of a partner and/or emotional, sexual or physical violence over the past 6 months). Eligible women randomised to the comparison group will be emailed confirming their enrolment in the study and will receive a link to the comparison website. The comparison website is a standard website, and will consist of the study questions, a standard emergency safety plan and links to domestic violence services and resources.
Control group
Active

Outcomes
Primary outcome [1] 293647 0
Mean self-efficacy score as measured using the General Self-Efficacy Scale (Schwarzer & Jerusalem, 1995).
Timepoint [1] 293647 0
Baseline, immediately after completion, and at 6 and 12 months following completion.
Primary outcome [2] 293648 0
Mean depression score as measured by The Center for Epidemiologic Studies Depression Scale Revised (CESD-R) (Eaton, Muntaner, Smith, Tien & Ybarra, 2004)
Timepoint [2] 293648 0
Baseline, and at 6 and 12 months following completion.
Secondary outcome [1] 311516 0
Mean number of helpful actions for safety and wellbeing (item showing a checklist of possible actions)
Timepoint [1] 311516 0
Baseline and 6 months following completion.
Secondary outcome [2] 311517 0
Mean level of fear of partner as measured by a visual analogue scale
Timepoint [2] 311517 0
Baseline and 12 months following completion.
Secondary outcome [3] 311518 0
Cost-effectiveness as assessed by additional cost per point change in self-efficacy and per point change on CESD-R, where cost is measured by time spent on website and number of services used in an adapted version of an instrument from the Database of Instruments for Resource Use Management (Watson et al. 2013).
Timepoint [3] 311518 0
Baseline and 12 months following completion.

Eligibility
Key inclusion criteria
-Female
-Aged between 16-50
-Residing in Australia
-Has access to a safe computer and internet connection
-Had an intimate partner do ANY of the following in the past 6 months: Made her feel afraid or unsafe; Followed or harassed her over the phone or online; Called her names, humiliated, bullied, or criticised her, or threatened her in any way; Isolated her from family or friends or restricted her behaviour in any way; Physically harmed her in any way; Forced her to do sexual things she didn't want to.
-Be willing to provide her name, a valid residential address, a valid email address and telephone number, and the first name, phone number and email address of 2 trusted contacts.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
If women's details are unable to be validated against the Australian Electoral Roll, they will be contacted for clarification. If they still cannot be validated, they will be excluded from the study.

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)
Women will click "Be A Part of the Project" from the study homepage, which will direct them to an online eligibility screening questionnaire and information about the study. Once they have filled in the eligibility screens, their personal details, and consented to participate, their information is sent to a registration database for enrolment. The database automatically randomises them into the intervention or comparison group, and an email is sent to them containing the appropriate website link and their login details. As the websites are identical in design, but differ only in content, women's allocation to a particular group will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer
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
Safety/efficacy
Statistical methods / analysis
A final sample size of at least 141 women in each of the two groups will be required to detect differences of a third of a standard deviation between group means on the primary outcomes at 6 and 12 months, with at least 80% power (alpha 5%, 2-sided test). This means that, based on an attrition rate of 30% by the 12 month follow-up time point, at least 404 eligible women will need to be recruited to the baseline phase of the trial (202 women in each group). The attrition rate is based on previous studies with this population.

Characteristics of participants in each of the two study arms will be summarised using means and standard deviations (or percentiles) for continuous data, and frequencies and percentages for categorical data. Characteristics of participants in the two study arms will be compared at baseline to ensure that the randomisation was effective. Subsequent analyses will adjust for any baseline imbalances between groups strongly associated with the outcomes. Mixed effects linear regression will be used to compare scores between the two study groups on continuous outcomes. Marginal logistic regression using Generalised Estimating Equations (GEE) will be used to compare results for the two groups on binary outcomes. All regression models will adjust for baseline outcome measures and for any baseline imbalances strongly associated with the outcomes. Analyses will also take into account repeated measures over time where appropriate. A two-tailed alpha level of .05 will be used throughout analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/12/2014
Actual
21/12/2014
Date of last participant enrolment
Anticipated
21/06/2015
Actual
29/08/2015
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
404
Accrual to date
Final
430
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290285 0
Government body
Name [1] 290285 0
Australian Research Council
Country [1] 290285 0
Australia
Primary sponsor type
Individual
Name
Professor Kelsey Hegarty
Address
Department of General Practice
The University of Melbourne
200 Berkeley Street
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 288998 0
Individual
Name [1] 288998 0
Professor Cathy Humphreys
Address [1] 288998 0
Department of Social Work
The University of Melbourne
161 Barry Street
Carlton VIC 3053
Country [1] 288998 0
Australia
Secondary sponsor category [2] 289071 0
Individual
Name [2] 289071 0
Dr Laura Tarzia
Address [2] 289071 0
Department of General Practice
The University of Melbourne
200 Berkeley St
Carlton VIC 3053
Country [2] 289071 0
Australia
Other collaborator category [1] 278257 0
Individual
Name [1] 278257 0
Ms Jodie Valpied
Address [1] 278257 0
Department of General Practice
The University of Melbourne
200 Berkeley St
Carlton VIC 3053
Country [1] 278257 0
Australia
Other collaborator category [2] 278258 0
Individual
Name [2] 278258 0
Professor Angela Taft
Address [2] 278258 0
Judith Lumley Centre
La Trobe University
215 Franklin St,
Melbourne VIC 3000
Country [2] 278258 0
Australia
Other collaborator category [3] 278259 0
Individual
Name [3] 278259 0
Professor Elizabeth Murray
Address [3] 278259 0
University College London
e-Health Unit
Research Department of Primary Care and Population Health
Upper Third Floor
UCL Medical School (Royal Free Campus)
Rowland Hill Street, London NW3 2PF
Country [3] 278259 0
United Kingdom
Other collaborator category [4] 278260 0
Individual
Name [4] 278260 0
Professor Nancy Glass
Address [4] 278260 0
Johns Hopkins University
School of Nursing
525 N. Wolfe Street
Baltimore, MD 21205
Country [4] 278260 0
United States of America
Other collaborator category [5] 278261 0
Individual
Name [5] 278261 0
Associate Professor Lisa Gold
Address [5] 278261 0
Deakin University
Population Health SRC
221 Burwood Highway
Burwood VIC 3125
Country [5] 278261 0
Australia
Other collaborator category [6] 278262 0
Individual
Name [6] 278262 0
Ms Kah-Ling Sia
Address [6] 278262 0
Deakin University
Population Health SRC
221 Burwood Hwy
Burwood VIC 3125
Country [6] 278262 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291992 0
The University of Melbourne Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 291992 0
Ethics committee country [1] 291992 0
Australia
Date submitted for ethics approval [1] 291992 0
Approval date [1] 291992 0
16/09/2014
Ethics approval number [1] 291992 0
1442953

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

Contacts
Principal investigator
Name 52666 0
Prof Kelsey Hegarty
Address 52666 0
Department of General Practice
The University of Melbourne
200 Berkeley Street
Carlton VIC 3053
Country 52666 0
Australia
Phone 52666 0
+61 3 8344 4092
Fax 52666 0
Email 52666 0
k.hegarty@unimelb.edu.au
Contact person for public queries
Name 52667 0
Laura Tarzia
Address 52667 0
Department of General Practice
The University of Melbourne
200 Berkeley Street
Carlton VIC 3053
Country 52667 0
Australia
Phone 52667 0
+61 3 9035 8604
Fax 52667 0
Email 52667 0
laura.tarzia@unimelb.edu.au
Contact person for scientific queries
Name 52668 0
Laura Tarzia
Address 52668 0
Department of General Practice
The University of Melbourne
200 Berkeley Street
Carlton VIC 3053
Country 52668 0
Australia
Phone 52668 0
+61 3 9035 8604
Fax 52668 0
Email 52668 0
laura.tarzia@unimelb.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE).2015https://dx.doi.org/10.1186/s12889-015-2072-z
EmbaseAn online healthy relationship tool and safety decision aid for women experiencing intimate partner violence (I-DECIDE): a randomised controlled trial.2019https://dx.doi.org/10.1016/S2468-2667%2819%2930079-9
N.B. These documents automatically identified may not have been verified by the study sponsor.