Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001164189
Ethics application status
Approved
Date submitted
6/08/2019
Date registered
20/08/2019
Date last updated
23/05/2023
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early vocational intervention for people after stroke: A randomised pilot trial
Scientific title
Does an vocational intervention delivered early to people after stroke increase return to work rates at 6 months more than usual clinical rehabilitation: A randomised pilot trial
Secondary ID [1] 298924 0
nil
Universal Trial Number (UTN)
U1111-1237-1246
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 313903 0
Condition category
Condition code
Stroke 312316 312316 0 0
Haemorrhagic
Stroke 312355 312355 0 0
Ischaemic
Physical Medicine / Rehabilitation 312356 312356 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Early Vocational Rehabilitation Program is an early, individually tailored intervention that aims to improve the ability of people to return to work after stroke. It assesses the participants’ role as a worker alongside their stroke-related impairments to develop acceptable strategies to overcome problems and co-ordinate appropriate support from health care professionals, employers and community services.
The intervention is provided over a 12 week period and although total number of sessions will depend on the participant's needs, it will be no less than weekly (minimum of 12 sessions); consistent with usual occupational therapy session lengths will be 1 hour in length. There will be a maximum of five sessions per week for 12 weeks.
The intervention content comprises of key components that are delivered across four phases: 1. orientation to the participants' worker role; 2. building awareness, skills and, strategies through the use of video feedback, assessment and grading of core work activities; 3. work preparation (work hardening), that will include the simulation of pre-injury work tasks (such as developing quotes or constructing furniture); and 4. Support (to liaise with employer / to complete a work trial / to find a job / to negotiate return to work). Each stage will be tailored to each participant. Tailoring to meet each participant's unique work goal will occur, elements for tailoring will include the content of each therapy session, who is involved in the rehabilitation, how much support is provided post-discharge, and whether the employer / workplace is involved or not - this will occur to ensure the unique work-goals set by each participant can be met. Tailoring will occur according to participants’ needs and preferences, for example, whether the participant consents to employer liaison and workplace visits or whether the participant accepts advice only about employer liaison.
The intervention is delivered by an experienced occupational therapist with at least 5 years experience.
The intervention is delivered face to face, provided individually to each participant. Employer liaison (which is a potential support element) may be via telephone. The intervention will commence during the participant's hospitalisation (rehabilitation hospital), but will additionally occur in the participant's home and potentially the workplace (if permission is provided). Adherence to the protocol will be monitored by auditing clinical notes completed at the conclusion of therapy sessions.
Intervention code [1] 315203 0
Rehabilitation
Comparator / control treatment
Both groups will receive usual (clinical) rehabilitation. Clinical rehabilitation at participating hospital sites includes multidisciplinary rehabilitation by experienced allied health clinician team inclusive of occupational therapy, speech pathology, physiotherapy, neuropsychology, clinical psychology, nutrition and exercise physiology. Standard practice is to provide an occupational therapy assessment (that is likely to include work-related issues) to all patients before discharge. There is, however, no specific vocational rehabilitation service nor employer/workplace liaison.
Control group
Active

Outcomes
Primary outcome [1] 320951 0
Participation level in work reported as:
- number of hours worked in the past week

Our trial will also separate out the role of student, volunteer, homemaker, and paid worker. Rates for each will be reported to permit easy international comparisons. Data for this outcome will be collected using a study specific survey.
Timepoint [1] 320951 0
Baseline, 12 weeks and six months (primary endpoint) post recruitment.
Primary outcome [2] 321065 0
Participation in work reported as:

The proportion of hours worked against a standard working week of 38 hours per week (7.6 hours per day; Fairwork Australia). The information will be collected using a study-specific survey.
Timepoint [2] 321065 0
Baseline , 12 weeks following recruitment and 6 months (primary endpoint) following recruitment. This information will be collected using a study-specific survey.
Primary outcome [3] 321066 0
Participation level in work reported as:
Number of days worked in the past month
Timepoint [3] 321066 0
Baseline, 12 weeks post recruitment and 6 months post recruitment ( primary endpoint).
Secondary outcome [1] 373480 0
Health-related quality of life measured using the EQ-5D-5L
Timepoint [1] 373480 0
Baseline, 12 weeks and six months from recruitment.
Secondary outcome [2] 373481 0
Presence of anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale.
Timepoint [2] 373481 0
Baseline. 12-weeks and six months post recruitment
Secondary outcome [3] 373483 0
Work and social functioning will be assessed using Work and Social Adjustment Scale, where respondents rate their ability to work, manage home duties, participate in social leisure activities, and maintain close relationships.
Timepoint [3] 373483 0
Baseline, 12-weeks and six months after recruitment.
Secondary outcome [4] 373484 0
Level of functional autonomy will be measured using the Autonomy Measurement System (SMAF)
Timepoint [4] 373484 0
Baseline, 12-weeks, 6 months
Secondary outcome [5] 373485 0
Level of global disability will be measured using the modified Rankin Scale at all time-points, in adherence with the SRRR recommendations.
Timepoint [5] 373485 0
Baseline, 12-weeks and six months
Secondary outcome [6] 373486 0
Work self-efficacy, measured using a single question from the workability index, as follows. 'Assume that your workability at its best has a value of 10 points. How many points would you give your current workability?’ The question has shown to be a good predictor of retirement due to work disability and mortality in people with acquired brain injury. The lowest score is zero (0).
Timepoint [6] 373486 0
Baseline, 12-weeks and six months post recruitment
Secondary outcome [7] 373487 0
Confidence: measured using the Confidence after Stroke Measure (CaSM)
Timepoint [7] 373487 0
Baseline, 12-weeks and six months from recruitment
Secondary outcome [8] 373867 0
Participation in daily activities using the Nottingham Extended Activities of Daily Living Index.
Timepoint [8] 373867 0
Baseline, 12 weeks and six months post recruitment.

Eligibility
Key inclusion criteria
Aged 18 years and older.
Diagnosis of stroke (< 4 months)
In work at stroke onset (including self-employed, paid or unpaid)
A stated goal of returning to employment
Willing and have the capacity to provide informed consent to participate in the study
Have enough proficiency in English to contribute to the data collection required for research
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) non-English speaker; (2) less than year 10 formal education (school to aged 15 y); (3) history of non-stroke neuropsychological disorder resulting in cognitive impairment not likely to respond to rehabilitation (e.g., vascular dementia, Alzheimer disease); (4) receptive language or cognitive impairment significant enough to prevent the candidate from meaningfully participating in the intervention.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by a process of minimization using an online randomisation package to 1 of 2 groups. Minimization will aim to balance on 3 factors: starting a return to work status (unemployed/underemployed), age, and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will focus on confidence interval estimation rather than formal hypothesis testing. Eligibility, consent and recruitment rates will be reported to determine the acceptability of randomisation. Reasons for ineligibility, non-consent and non-randomisation will be summarised. Rates of retention in, adherence to and completion of, treatment will be summarised by group. Follow-up rates and compliance with outcome measurement will similarly demonstrate the acceptability of the outcome measures. Reasons for drop-out will also be summarised where possible. We will also report the difference and its confidence interval for follow-up rates between the intervention and control groups, to identify large differences between the two arms. Drop-out rates over time will also be reported. Adverse events will be monitored throughout and compared across intervention and control groups. Levels of missing data for outcomes will be summarised and compared between groups. All outcome measures will be summarised, using appropriate descriptive statistics (i.e. means and standard deviations, medians and IQR or proportions) and 95% confidence intervals constructed for the difference in outcomes between control and intervention groups. To generate evidence of proof of principle, we will generate a range of confidence intervals around the main estimate for the treatment effect to inform us as to the likelihood of where the ‘true’ estimate may lie and informing the power calculations for a definitive phase III trial. Analysis will adjust for key predictors; job type, baseline hours of work and, stroke severity

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2019
Actual
13/11/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
30/04/2022
Date of last data collection
Anticipated
31/10/2022
Actual
31/10/2022
Sample size
Target
54
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14431 0
Caulfield Hospital - Caulfield
Recruitment hospital [2] 14463 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 27441 0
3162 - Caulfield
Recruitment postcode(s) [2] 27478 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 303469 0
Government body
Name [1] 303469 0
MRFF- Stroke Foundation Initiative Funding Program 'Return to Life Return to Work'
Country [1] 303469 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Central Clinical School
Monash Univesity
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 303526 0
None
Name [1] 303526 0
Address [1] 303526 0
Country [1] 303526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303999 0
Alfred Health Ethics and Research Governance
Ethics committee address [1] 303999 0
Ethics committee country [1] 303999 0
Australia
Date submitted for ethics approval [1] 303999 0
29/07/2019
Approval date [1] 303999 0
02/09/2019
Ethics approval number [1] 303999 0
Alfred/490-29

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

Contacts
Principal investigator
Name 95506 0
Prof Natasha Lannin
Address 95506 0
Occupational Therapy Department
Alfred Health
55 Commercial Rd
Melbourne
Victoria 3004
Country 95506 0
Australia
Phone 95506 0
+61 41 7135153
Fax 95506 0
Email 95506 0
[email protected]
Contact person for public queries
Name 95507 0
Natasha Lannin
Address 95507 0
Occupational Therapy Department
Alfred Health
55 Commercial Rd
Melbourne
Victoria 3004
Country 95507 0
Australia
Phone 95507 0
+61 41 7135153
Fax 95507 0
Email 95507 0
[email protected]
Contact person for scientific queries
Name 95508 0
Natasha Lannin
Address 95508 0
Occupational Therapy Department
Alfred Health
55 Commercial Rd
Melbourne
Victoria
3004
Country 95508 0
Australia
Phone 95508 0
+61 41 7135153
Fax 95508 0
Email 95508 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
It is not yet known if there will be a plan to make IPD available.


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.