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Trial registered on ANZCTR


Registration number
ACTRN12619001537145
Ethics application status
Approved
Date submitted
26/10/2019
Date registered
7/11/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
7/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MS JobSeek: harnessing peer support to help job-seekers with multiple sclerosis find employment.
Scientific title
Development and evaluation of an online peer-supported intervention for job-seekers with multiple sclerosis: a pilot randomised controlled trial
Secondary ID [1] 299419 0
Nil known
Universal Trial Number (UTN)
U1111-1241-0921
Trial acronym
Linked study record
This record is a follow-up study to ACTRN12617000728336

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 314594 0
Condition category
Condition code
Neurological 312933 312933 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary intervention will involve an online discussion forum monitored by peers with multiple sclerosis and overseen by a health psychologist. Participants will be required to login with a password to the discussion forum at least once per week for at least 5 minutes, over a 2-month period. They are not required to log in at the same time. The first time they log in they will be encouraged to introduce themselves to the discussion (community) forum. Peer mentors (volunteers with MS who are currently employed) will post questions or topics of interest to the group, including examples from their own work experiences, in order to stimulate discussion. Both the moderator (health psychologist) and mentors will answer discussion threads. The moderator will also view forum activity and email those participants who fail to login for more than 1 week, encouraging them to join the discussion.

In addition, intervention participants will be emailed a 7-module written information resource on enrollment (see list of modules, below). This resource, purposely developed and pilot tested by our team, covers basic job searching and career planning skills (see below). Each module includes hyperlinks to online resources (e.g. writing a resume, relevant government legislation and job search engines) which participants can access at their discretion. The modules are self-paced although should take no more than 20 minutes, each, to complete.

Module Topics covered:
1 Introduction: Overview, including contact details for moderator
2 Job facts: Facts about employment, benefits of work, managing work barriers
3 Finding work: Researching potential employers, study options, disability employment
services in Australia, maintaining psychological health
4 &5 Interviewing skills: Determining ‘job-fit’, cover letter and resumes, interview
preparation; answering difficult interview questions, asking interview questions,
interview follow-up
6 Maintaining work: Managing symptoms in the workplace, managing the work
environment
7 Career development: Maintaining and developing work skills, finding a mentor
Intervention code [1] 315667 0
Behaviour
Comparator / control treatment
The 7-module information resource provided as part of the MS JobSeek intervention (described above) will be emailed to control participants on enrollment. Participants can view this material at their own pace during the course of the study.
Control group
Active

Outcomes
Primary outcome [1] 321533 0
Job Search Behavior Scale
Timepoint [1] 321533 0
On enrolment and 2 months thereafter
Secondary outcome [1] 375260 0
Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global)
Timepoint [1] 375260 0
On enrolment and 2 months thereafter
Secondary outcome [2] 375261 0
Job Search Self-efficacy Scale
Timepoint [2] 375261 0
On enrolment and 2-months thereafter
Secondary outcome [3] 375262 0
Self-reported employment status based on a study-specific questionnaire (i.e. single item with 6 response options: full-, part-time, casual work, unpaid work (volunteering), not working but available to take up employment, other)
Timepoint [3] 375262 0
On enrolment and 2 months thereafter

Eligibility
Key inclusion criteria
Eligibility criteria include adults of working age with relapsing-remitting or progressive forms of multiple sclerosis who are currently unemployed and want to return to the workforce, residing in Australia, with English fluency and access to a computer, tablet or smartphone with internet connection.
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are medically retired will be excluded, given the focus is on individuals who have the capacity to work. It is anticipated that people with major cognitive impairments will self-exclude because they are unlikely to access, or benefit from, the study materials.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisations will be performed by a statistician otherwise not involved in the trial (Adelaide Health Technology Assessment: https://www.adelaide.edu.au/ahta/).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule will be created using Stata v15.0, by a statistician not otherwise involved in the study, using randomly permuted blocks of size 2 and 4. The randomisation schedule, consisting of a unique non-informative study identification number, and a group allocation, will be provided to an independent investigator, who will allocate IDs sequentially to recruited participants as they are randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be performed on an intention-to-treat basis according to a pre-specified statistical analysis plan. Job-search behaviour (the primary outcome) will be compared between the two randomised groups using a repeated measures linear mixed effects model, with the model including terms for time, group, and the interaction between time and group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303926 0
Charities/Societies/Foundations
Name [1] 303926 0
Multiple Sclerosis Research Australia
Address [1] 303926 0
PO Box 625, North Sydney NSW 2059
Country [1] 303926 0
New Zealand
Primary sponsor type
University
Name
University of Adelaide
Address
School of Psychology
Faculty of Health and Medical Sciences
North Terrace campus
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 304077 0
None
Name [1] 304077 0
Address [1] 304077 0
Country [1] 304077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304425 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 304425 0
Research Services
The University of Adelaide
SA 5005 AUSTRALIA
Ethics committee country [1] 304425 0
Australia
Date submitted for ethics approval [1] 304425 0
24/09/2019
Approval date [1] 304425 0
25/10/2019
Ethics approval number [1] 304425 0
H-2019-206

Summary
Brief summary
Our team will develop and test an online forum, MS JobSeek, led by employed peers with multiple sclerosis and overseen by a health psychologist. The peers share their work experiences and help to motivate and encourage persons with MS to explore work and study options. This group coaching and mentoring is supplemented with educational material to help users better understand the current job market. To maximise reach and quality of access we will deliver this targeted support and mentoring via the internet.

We will examine whether MS JobSeek is effective in supporting return-to-work progression for persons with relapsing remitting or progressive multiple sclerosis using a rigorous scientific study design. The findings will help to generate new evidence on how job-seekers with multiple sclerosis engage with, and respond to, peer mentoring. We also hope to provide a framework for how peer support services might be run and optimised in vocational care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96914 0
Dr Diana Dorstyn
Address 96914 0
School of Psychology
University of Adelaide
ADELAIDE SA 5005
Country 96914 0
Australia
Phone 96914 0
+61 08 8313 0649
Fax 96914 0
Email 96914 0
diana.dorstyn@adelaide.edu.au
Contact person for public queries
Name 96915 0
Dr Diana Dorstyn
Address 96915 0
School of Psychology
University of Adelaide
ADELAIDE SA 5005
Country 96915 0
Australia
Phone 96915 0
+61 08 8313 0649
Fax 96915 0
Email 96915 0
diana.dorstyn@adelaide.edu.au
Contact person for scientific queries
Name 96916 0
Dr Diana Dorstyn
Address 96916 0
School of Psychology
University of Adelaide
ADELAIDE SA 5005
Country 96916 0
Australia
Phone 96916 0
+61 08 8313 0649
Fax 96916 0
Email 96916 0
diana.dorstyn@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval requires that only group, not individual participant data be made publicly available.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5475 0
Ethical approval
Citation [1] 5475 0
Link [1] 5475 0
Email [1] 5475 0
Other [1] 5475 0
Summary results
No Results