Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000812493
Ethics application status
Approved
Date submitted
17/06/2016
Date registered
21/06/2016
Date last updated
30/09/2022
Date data sharing statement initially provided
30/09/2022
Date results information initially provided
30/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Getting back to work: a job resource package for adults with spinal cord injury
Scientific title
Development and preliminary trial of an online vocational resource for Australian adults with spinal cord injury
Secondary ID [1] 289485 0
LSA-D000653
Universal Trial Number (UTN)
U1111-1184-4012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 299176 0
Condition category
Condition code
Injuries and Accidents 299187 299187 0 0
Other injuries and accidents
Mental Health 299208 299208 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to read an online job-related information package comprising of 7 modules over a 4 week period:
- 1 x introductory module
- 3x modules related to the job-seeking process (i.e. job facts, current job market)
- 2 x modules on job interviewing (i.e. resume writing, interview do’s and don’ts, employers’ needs)
- 1 x module on career development.

Each module includes activity worksheets, links to online resources, and opportunity for email correspondence with a moderator and trained clinical psychologist (lead applicant).

The modules are short (up to 30 mins) and designed to be self-paced. Participants are encouraged to complete the introductory module first. The remaining modules can be completed in any order.

The modules were developed by a multidisciplinary team of rehabilitation specialists including psychology, social work and neurology. A detailed description of the modules is available in an earlier publication by this research group: Dorstyn DS et al., (2016). Piloting an email-based resource package for job-seekers with Multiple Sclerosis. Disability and Rehabilitation. Advance Online Publication. 10 April 2016.

A log of modules completed by each participant will be documented in a follow-up survey.
Intervention code [1] 295071 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298668 0
Job self-efficacy - as measured by the Job Procurement Self-efficacy Scale (Wenzel,1993)
Timepoint [1] 298668 0
4 weeks post-intervention
Primary outcome [2] 298669 0
Job identity - as measured by the My Vocational Situation Scale (Holland, Johnston & Asama, 1993).
Timepoint [2] 298669 0
4 weeks post intervention
Secondary outcome [1] 324908 0
Optimism - as measured by the Life Orientation Test Revised (Scheier, Carver & Bridges, 1994).
Timepoint [1] 324908 0
4 weeks post-intervention
Secondary outcome [2] 324909 0
Mood (depression) - as measured by the Patient Health Questionnaire (Spitzer, Kroenke & Williams, 1999).
Timepoint [2] 324909 0
4 weeks post intervention

Eligibility
Key inclusion criteria
Adults (i.e. > 18 years of age) with a traumatic or non-traumatic spinal cord injury or spinal condition (e.g. transverse myelitis, guillain barre syndrome, cauda equina syndrome, spinal fractures, spinal stenosis) who are of working age (i.e. 18-65 years) and currently seeking work or looking to change jobs. Participants will need access to a personal computer and internet.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Being aged less than 18 years, being a carer or family member of an individual with SCI, cognitive or medical comorbidities that may impact on participation in the online intervention, adults with SCI who are not seeking work.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Treatment outcomes will be examined using a multiple case-study design to examine individual changes in pre-post intervention outcome for each standardised measure. Although the magnitude of this treatment change cannot be precisely predicted, due to the limited quantity and quality of online research with SCI groups, they can be extrapolated from results of web-based chronic disease self-management programs which have achieved moderate psychosocial improvements. Clinical feasibility will be determined by examining process outcomes: attrition rate and perceived consumer benefit of the information package.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/02/2016
Date of last participant enrolment
Anticipated
1/09/2016
Actual
1/11/2016
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
25
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293847 0
Government body
Name [1] 293847 0
Lifetime Support Authority of South Australia
Country [1] 293847 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace campus
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 292685 0
Charities/Societies/Foundations
Name [1] 292685 0
Paraquad Association of SA
Address [1] 292685 0
225 Greenhill Road
Dulwich SA 5065
Country [1] 292685 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295275 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 295275 0
North Terrace campus
Adelaide SA 5005
Ethics committee country [1] 295275 0
Australia
Date submitted for ethics approval [1] 295275 0
01/05/2015
Approval date [1] 295275 0
22/06/2015
Ethics approval number [1] 295275 0
H-2015-078

Summary
Brief summary
Research indicates a low employment rate among adults with spinal cord injury (SCI) despite many feeling capable of engaging in paid employment.

Resuming employment after SCI provides an opportunity to interact with others and has been shown to contribute to general wellbeing and life satisfaction.

Though specialist vocational rehabilitation services exist, barriers to accessing these services have been identified. These barriers include (but are not limited to): delays in the timeliness of vocational interventions, transportation and/or financial difficulties, and social stigma.

In this context, time-efficient, cost-effective and accessible methods of vocational service delivery present clinical appeal. This includes the use of information and communication technologies (i.e. Internet) to supplement face-to-face rehabilitation.

Specific aims will of this study will be to:
1. Develop and evaluate an online vocational resource for working-age adults with SCI.
2. Identify facilitators of, and barriers to, online learning

We expect to demonstrate that:
1. Vocational rehabilitation can be applied in an online format
2. Access to online services will facilitate and promote vocational behaviours and, potentially, contribute to positive mental health outcomes.
Trial website
Trial related presentations / publications
Diana Dorstyn, Rachel Roberts, Gregory Murphy, Ian Kneebone, Ashley Craig, Anna Chur-Hansen, Christine Migliorini, Elizabeth Potter, Ruth Marshall, Jillian Clark, Sharron Neeson, and Peter Stewart (2017). Can targeted job-information for adults with spinal cord dysfunction be effectively delivered online? A pilot study. The Journal of Spinal Cord Medicine. Advance Online Publication.
Public notes
Modules (in pdf form) will be translated to PQSA website following project completion

Contacts
Principal investigator
Name 66746 0
Dr Diana Dorstyn
Address 66746 0
School of Psychology
Faculty of Health Sciences
University of Adelaide
Adelaide SA 5005
Country 66746 0
Australia
Phone 66746 0
+61 8 8313 0649
Fax 66746 0
Email 66746 0
[email protected]
Contact person for public queries
Name 66747 0
Ms Elizabeth Potter
Address 66747 0
South Australian Spinal Cord Injury Research Centre
Hampstead Rehabilitation Centre
207-255 Hampstead Rd
Northfield SA 5085
Country 66747 0
Australia
Phone 66747 0
+61 8 8222 1860
Fax 66747 0
Email 66747 0
[email protected]
Contact person for scientific queries
Name 66748 0
Dr Diana Dorstyn
Address 66748 0
School of Psychology
Faculty of Health Sciences
University of Adelaide
Adelaide SA 5005
Country 66748 0
Australia
Phone 66748 0
+61 8 8313 0649
Fax 66748 0
Email 66748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Dorstyn D, Roberts R, Murphy G, Kneebone I, Craig ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCan targeted job-information for adults with spinal cord dysfunction be effectively delivered online? A pilot study.2019https://dx.doi.org/10.1080/10790268.2017.1321821
N.B. These documents automatically identified may not have been verified by the study sponsor.