Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000229279
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
12/02/2018
Date last updated
10/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
WEB-BASED EMPLOYEE DECISION AID TOOL - a tool to help working Australians (aged 18-65) decide if they should disclose their mental health condition at work.
READY - Reducing dEcisionAl conflict, a Decision aid tool for emploYees.
Scientific title
WEB-BASED EMPLOYEE DECISION AID TOOL
READY - Reducing dEcisionAl conflict, a Decision aid tool for emploYees.
A randomised controlled trial of a web-based tool to improve decisional conflict about disclosure by employees with a mental health condition
Secondary ID [1] 293781 0
Nil
Universal Trial Number (UTN)
Trial acronym
READY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 306176 0
Condition category
Condition code
Mental Health 305288 305288 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program (READY) is based around seven self-guided modules which have been pilot tested and refined through focus groups with employees who have disclosed mental health conditions and, designed to improve decisional conflict by informing on what could happen and reflecting on what has happened in previous experiences through modules including; risks and benefits, needs at work, values at work, deciding when the best time to tell is, reflecting on who the user has told in the past, deciding who should the user tell, and providing a summary of their answers.
Users must complete each interactive module to be able to move to the next module. Participants can log-in as many times as they like. At the end of each section participant will be asked if they would like to continue, if they would like to save and return, or if they would like to stop the intervention. If participants decide to stop the intervention they will be given the post-intervention questionnaires and then the intervention will stop. Once they have completed all modules or confirmed they would like to stop (exit/finish) they will be asked to complete the post-intervention questions immediately.
The application is supported by a research database which collects data, populates relevant interactive fields, and records time on site, number of modules completed, length of individual module use and frequency of access.

• Advantages and Disadvantages
• Needs at work
• Values at work
• Risks at work
• When would be the best time to tell
• Reflecting on previous disclosures
• Who would be the best person to tell

The intervention can be completed on any device that has adequate internet access, at home or work etc. Participants will have open access for 2 weeks. We expect that each module would take 5-10 minutes to complete, Participants can decide how many modules they would like to visit, we would expect at least 30 mins is required to complete the questionnaires pre screening and 30 minutes in total for the follow-up questionnaires.
Intervention code [1] 300034 0
Treatment: Other
Comparator / control treatment
The control group will be given access to a visually similar website with four modules that contain only information about rights and responsibilities, laws and legislations based on content from the HeadsUp website. The control arm is an information based arm only, containing content from the HeadsUp website a website containing a decision aid tool. We have obtained permission to use the content from the HeadsUp website as a control condition. The information in the control arm will be from the rights and responsibilities page and it will have 4 modules:
• Employee rights
• Privacy
• Employee responsibilities
• Safe workplace
Participants will have open access for 2 weeks. We expect that each module would take 5-10 minutes to complete, Participants can decide how many modules they would like to visit, we would expect at least 30 mins is required to complete the questionnaires pre screening and 30 minutes in total for the follow-up questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 304448 0
The main outcome is decisional conflict - measured by the Decisional Conflict Scale using the 10-item scale that measures, self-reported uncertainty, the level that they feel informed, clarity of values, whether they feel supported and effective decision-making. At post-test and follow-up two extra questions from the 16 point DCS will be asked if participants answer yes to questions 9 “Are you clear about the best choice for you?” &/or 10 “Do you feel sure about what to choose?” additional questions “Do you expect to stick with your decision?” and “Are you satisfied with your decision?” will be asked.

Timepoint [1] 304448 0
Assessments will occur at baseline, post-intervention, the primary time-point (immediately after intervention or at 2 weeks if participants do not complete modules in the given time frame) and follow-up 6 weeks post-intervention
Secondary outcome [1] 342000 0
Stage of decision making - stage of decision making scale. This is a 4 question scale to measure individual readiness to engage in decision making
Timepoint [1] 342000 0
Assessments will occur at baseline, post-intervention (immediately after intervention or at 2 weeks if participants do not complete modules in the given time frame) and follow-up 6 weeks post-intervention
Secondary outcome [2] 342733 0
Stress: The Perceived Stress Scale (PSS10)
Timepoint [2] 342733 0
Assessments will occur at baseline, post-intervention (immediately after intervention or at 2 weeks if participants do not complete modules in the given time frame) and follow-up 6 weeks post-intervention

Eligibility
Key inclusion criteria
• Aged between 18-65 years of age
• Be currently employed in a paid position
• Self-Identify as having a mental health condition (i.e. not identified by the employer)
• Have access to the internet
• Have a valid email address
• Be fluent in English
• Have not disclosed their current mental health condition to their employer
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Does not have access to reliable internet access at home or work for the duration of the study (6 weeks)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/11/2017
Date of last participant enrolment
Anticipated
30/04/2018
Actual
25/02/2018
Date of last data collection
Anticipated
18/06/2018
Actual
10/04/2018
Sample size
Target
92
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298398 0
Charities/Societies/Foundations
Name [1] 298398 0
Movember Foundation
Country [1] 298398 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Level 5 PMBC building Missenden Road
Camperdown NSW, 2050
Country
Australia
Secondary sponsor category [1] 297528 0
None
Name [1] 297528 0
Address [1] 297528 0
Country [1] 297528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299391 0
University of Sydney
Ethics committee address [1] 299391 0
Ethics committee country [1] 299391 0
Australia
Date submitted for ethics approval [1] 299391 0
12/09/2017
Approval date [1] 299391 0
17/10/2017
Ethics approval number [1] 299391 0
2017/740

Summary
Brief summary
The READY study is a double-blinded randomised controlled trial with two parallel arms. A 2 week web-based employee decision aid tool and a control website. Participants will have open access to the website for 2 weeks, this is to assist the participants in being able to make a decision by understanding that the decision aid tool will come to an end at the 2 week period with an expectation of a decision to be made at this point as informed in the PIS. Assessments will occur at baseline, post-intervention (immediately after intervention) and follow-up 6 weeks post-intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80258 0
Prof Nicholas Glozier
Address 80258 0
The University of Sydney
Level 5 PMBC Building
Missenden Road
Camperdown NSW, 2050
Country 80258 0
Australia
Phone 80258 0
+610295151439
Fax 80258 0
Email 80258 0
nick.glozier@sydney.edu.au
Contact person for public queries
Name 80259 0
Ms Elizabeh Stratton
Address 80259 0
The University of Sydney
Level 5 PMBC Building
Missenden Road
Camperdown NSW, 2050
Country 80259 0
Australia
Phone 80259 0
+610295151439
Fax 80259 0
Email 80259 0
eodg5192@uni.sydney.edu.au
Contact person for scientific queries
Name 80260 0
Ms Elizabeth Stratton
Address 80260 0
The University of Sydney
Level 5 PMBC Building
Missenden Road
Camperdown NSW, 2050
Country 80260 0
Australia
Phone 80260 0
+610295151439
Fax 80260 0
Email 80260 0
eodg5192@uni.sydney.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
No additional documents have been identified.