Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000728336
Ethics application status
Approved
Date submitted
16/05/2017
Date registered
18/05/2017
Date last updated
25/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting job-seeking behaviour in adults with a physical disability
Scientific title
Utilising online learning to promote job-seeking behaviour in adults with a physical disability
Secondary ID [1] 291963 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is an extension (RCT) of a trial previously registered on ANZCTR (reg no. ACTRN12616000812493)

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 303310 0
Multiple Sclerosis 303311 0
Condition category
Condition code
Neurological 302750 302750 0 0
Multiple sclerosis
Injuries and Accidents 302751 302751 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will receive 7 online modules, by email, on study enrollment. The modules, based on established principles of successful vocational rehabilitation, include 1 introductory module and 6 learning modules (see below). Each module has hyperlinks to activity worksheets and online resources. The modules are self-paced although should take no more than 20 minutes, each, to complete. To promote engagement with the resource, participants will receive standardised email prompts once weekly over the 4 week intervention period from a trained moderator (Clinical Psychologist, > 5 years experience). Participants will be asked how many, and which, modules they have completed at the second (4 week) assessment.

Structure and content of online resource

Module Topics covered
1 Introduction: Overview, including contact details for moderator
2 Job facts: Facts and figures 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] 298092 0
Behaviour
Intervention code [2] 298093 0
Lifestyle
Comparator / control treatment
Wait-list control participants will be offered the intervention at 4 weeks post enrolment, after completing the baseline and 4 week surveys.
Control group
Active

Outcomes
Primary outcome [1] 302140 0
Vocational identity (My Vocational Situation Scale). This outcome was included for participants with multiple sclerosis only.
Timepoint [1] 302140 0
On enrolment and 4 weeks thereafter
Primary outcome [2] 302141 0
Job self-efficacy (a composite of the Job Procurement Self Efficacy Scale and Work Self-efficacy Scale)
Timepoint [2] 302141 0
On enrolment and 4 weeks thereafter
Secondary outcome [1] 334926 0
Mood (Patient Health Questionnaire-9)
Timepoint [1] 334926 0
On enrolment and 4 weeks thereafter
Secondary outcome [2] 334927 0
Optimism (Life Orientation Test-Revised)
Timepoint [2] 334927 0
On enrolment and 4 weeks thereafter
Secondary outcome [3] 348813 0
Multiple Sclerosis Work Difficulties Questionnaire. This outcome was included for participants with multiple sclerosis only.
Timepoint [3] 348813 0
On enrolment and 4 weeks thereafter

Eligibility
Key inclusion criteria
Community-dwelling adults with a spinal cord injury or disorder (acquired or congenital) or multiple sclerosis (MS), Eligible participants must be actively seeking employment and/or wanting to return to the workforce. Further requirements will be English fluency, sufficient computer/or basic literacy proficiency and access to a PC with an internet provider.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who report significant cognitive concerns, are retired, or on disability support and not looking for employment are inelgibile

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Enrolment of approximately 70 participants (i.e. 35 intervention, 35 control) with the expectation of retaining a minimum sample size of 50 (or 25 per group) post-intervention is required. This minimum N would detect a large standardized mean difference between the intervention and control groups (Cohens’ d effect size = 0.5) for each of the primary outcomes (with a statistical power of .8 and alpha at .05 for a two-sided independent samples t test).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/04/2017
Date of last participant enrolment
Anticipated
Actual
21/05/2018
Date of last data collection
Anticipated
29/06/2018
Actual
15/06/2018
Sample size
Target
70
Accrual to date
Final
143
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296476 0
Charities/Societies/Foundations
Name [1] 296476 0
auDA Foundation
Country [1] 296476 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace campus
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 295433 0
None
Name [1] 295433 0
Address [1] 295433 0
Country [1] 295433 0
Other collaborator category [1] 279574 0
Hospital
Name [1] 279574 0
SA Health/Hampstead Rehabilitation Centre
Address [1] 279574 0
207-235 Hampstead Road, Northfield South Australia 5085
Country [1] 279574 0
Australia
Other collaborator category [2] 279575 0
Charities/Societies/Foundations
Name [2] 279575 0
Paraquad SA
Address [2] 279575 0
225 Greenhill Road, DULWICH South Australia 5065
Country [2] 279575 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297698 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 297698 0
Ethics committee country [1] 297698 0
Australia
Date submitted for ethics approval [1] 297698 0
11/01/2017
Approval date [1] 297698 0
24/01/2017
Ethics approval number [1] 297698 0
2015078
Ethics committee name [2] 301029 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 301029 0
Ethics committee country [2] 301029 0
Australia
Date submitted for ethics approval [2] 301029 0
Approval date [2] 301029 0
29/02/2016
Ethics approval number [2] 301029 0
2016-019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2907 2907 0 0
/AnzctrAttachments/372952-H-2016-019 Dorstyn approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 74866 0
Dr Diana Dorstyn
Address 74866 0
School of Psychology
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace campus
Adelaide SA 5005
Country 74866 0
Australia
Phone 74866 0
+61 8 8313 0649
Fax 74866 0
Email 74866 0
diana.dorstyn@adelaide.edu.au
Contact person for public queries
Name 74867 0
Diana Dorstyn
Address 74867 0
School of Psychology
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace campus
Adelaide SA 5005
Country 74867 0
Australia
Phone 74867 0
+61 8 8313 0649
Fax 74867 0
Email 74867 0
diana.dorstyn@adelaide.edu.au
Contact person for scientific queries
Name 74868 0
Diana Dorstyn
Address 74868 0
School of Psychology
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace campus
Adelaide SA 5005
Country 74868 0
Australia
Phone 74868 0
+61 8 8313 0649
Fax 74868 0
Email 74868 0
diana.dorstyn@adelaide.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
EmbaseWork and SCI: a pilot randomized controlled study of an online resource for job-seekers with spinal cord dysfunction.2019https://dx.doi.org/10.1038/s41393-018-0200-1
N.B. These documents automatically identified may not have been verified by the study sponsor.