Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000179538
Ethics application status
Approved
Date submitted
24/01/2024
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a return-to-work rehabilitation program in South Australia
Scientific title
Preliminary evaluation of a rehabilitation program based on simulation techniques to rebuild capacity to return to work following an injury.
Secondary ID [1] 311352 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal injuries 332611 0
Neurological injuries 332613 0
Condition category
Condition code
Injuries and Accidents 329314 329314 0 0
Other injuries and accidents
Mental Health 329315 329315 0 0
Anxiety
Mental Health 329316 329316 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The work simulation rehabilitation program evaluated in the current study involves the following components:
- face to face, individual sessions in a community setting;
- 3 sessions per week for 90-180 mins each (depending on initial assessment and tolerances) over 4-6 weeks;
- on-site work assessments (where applicable);
- simulated work tasks performed under the supervision of a physiotherapist in a customised facility with work environments that mimic real workplaces (e.g., forklift and warehouse simulation space, office workstation) with work capacity assessed using the ErgoScience Functional Capacity Evaluation protocol);
- cognitive-behavioural therapy (where required) to manage psychological distress and reinforce coping, provided by a rehabilitation counsellor; and
-treatment adherence recorded via session attendance.
Intervention code [1] 327796 0
Rehabilitation
Intervention code [2] 327952 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337133 0
Degree of persistent pain and disability as measured by a composite primary outcome, the Örebro Musculoskeletal Pain Screening Questionnaire (Short form)
Timepoint [1] 337133 0
Baseline (at enrollment) and 8 weeks post-enrollment
Secondary outcome [1] 430825 0
Participant experience of, and satisfaction with, the rehabilitation service using a composite secondary outcome of service satisfaction.
Timepoint [1] 430825 0
8 weeks post-enrollment
Secondary outcome [2] 431082 0
Engagement in job-seeking activities
Timepoint [2] 431082 0
8 weeks post-enrollment.
Secondary outcome [3] 431526 0
Perceived change in physical and psychological functioning, assessed as a composite secondary outcome.
Timepoint [3] 431526 0
8 weeks post enrollment

Eligibility
Key inclusion criteria
All clients referred to an accredited rehabilitation service provider (project partner) for a work-related injury (physical or psychological) over a 12-month period will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients with an injury sustained > 5 years ago who have been referred for follow-up services (rather than initial rehabilitation)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
Standardised group mean change scores and individual reliable change scores will be calculated for the primary (pre-post) outcome measure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315608 0
University
Name [1] 315608 0
The University of Adelaide
Country [1] 315608 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace campus, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 317705 0
None
Name [1] 317705 0
Address [1] 317705 0
Country [1] 317705 0
Other collaborator category [1] 282928 0
Commercial sector/Industry
Name [1] 282928 0
WorkGain Solutions Ltd
Address [1] 282928 0
Adelaide Airport SA 5950
Country [1] 282928 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314496 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 314496 0
Ethics committee country [1] 314496 0
Australia
Date submitted for ethics approval [1] 314496 0
06/09/2023
Approval date [1] 314496 0
26/10/2023
Ethics approval number [1] 314496 0
H-2023-263

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

Contacts
Principal investigator
Name 131790 0
A/Prof Diana Dorstyn
Address 131790 0
University of Adelaide, North Terrace campus, Adelaide SA 5000
Country 131790 0
Australia
Phone 131790 0
+61 8 8313 0649
Fax 131790 0
Email 131790 0
[email protected]
Contact person for public queries
Name 131791 0
Diana Dorstyn
Address 131791 0
University of Adelaide, North Terrace campus, Adelaide SA 5000
Country 131791 0
Australia
Phone 131791 0
+61 8 8313 0649
Fax 131791 0
Email 131791 0
[email protected]
Contact person for scientific queries
Name 131792 0
Diana Dorstyn
Address 131792 0
University of Adelaide, North Terrace campus, Adelaide SA 5000
Country 131792 0
Australia
Phone 131792 0
+61 8 8313 0649
Fax 131792 0
Email 131792 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
Ethics approval is contingent on only group, rather than individual, data being publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21432Ethical approval  [email protected] 387183-(Uploaded-18-01-2024-10-43-19)-Study-related document.pdf



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.