Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001118796
Ethics application status
Approved
Date submitted
8/08/2022
Date registered
15/08/2022
Date last updated
15/08/2022
Date data sharing statement initially provided
15/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of new models of rehabilitation on work and health outcomes after stroke
Scientific title
Effectiveness of two models of vocational rehabilitation to improve return to work rates in adults after stroke: a trial-within-a-cohort study.
Secondary ID [1] 307721 0
GNT2008141
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 327287 0
Condition category
Condition code
Stroke 324419 324419 0 0
Haemorrhagic
Stroke 324468 324468 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial within a cohort.

Nested RCT interventions
Intervention Arm 1: Resource Facilitation.
- participants allocated to this group will receive support to develop vocational goals in collaboration with their clinical rehabilitation team, and encouragement to use their usual clinical rehabilitation team to address these goals.
- occupational therapist with minimum 3-years experience and trained in vocational rehabilitation will provide the intervention.
- mode of delivery will include face-to-face, telehealth (telephone and videoconference), provided individually.
- 3 x 1-hour sessions, once/week for 3 weeks (schedule will be determined by the participant).
Occupational therapy sessions include assessment of the participant's stroke-related functional impairments, activity analysis of job, and clinical goal-setting to determine vocational rehabilitation plan and necessary referrals; a strengths-weaknesses-opportunities-threats analysis supports the joint decision-making in preparation for the report.
- A session-attendance record will be used to record fidelity.

Intervention Arm 2: Specialist vocational rehabilitation
- receive vocational rehabilitation delivered by a central team of expert clinicians (including occupational therapy, speech pathology and neuropsychology). This intervention will target both impairments arising from stroke and support to transition back to work using case management.
- occupational therapist, speech pathologist and neuropscyhologist with experience and trained in vocational rehabilitation will provide the intervention.
- mode of delivery will include face-to-face, telehealth (telephone and videoconference), provided individually.
- 8-10 x 1-hour sessions, once/week for 8 weeks (schedule will be determined by the participant) plus a further 8 weeks of telephone support once transitioned back-to-work (case management).
Occupational therapy sessions include assessment of the participant's stroke-related functional impairments, activity analysis of job, and clinical goal-setting to determine vocational rehabilitation plan and necessary referrals; a strengths-weaknesses-opportunities-threats analysis supports the joint decision-making in preparation for the report.
For participants who identify needs unable to be met by their clinical rehabilitation with respect to return to driving, neuropsychology assessment, memory rehabilitation, and workplace communication training, the occupational therapist will arrange a referral to a specialist stroke clinician with experience in the specific area.
For those participants who are assessed as requiring further rehabilitation in work skills, a work hardening, work accommodation, worksite visits, and/or graded return to work programs will be developed as appropriate.
For those participants who return to work or a volunteer role, case management support may include workplace support (e.g. meetings and or education with employer/supervisor/colleagues; telephone counselling; joint problem solving). Support will centre around strategies to increase confidence in work activities.
- A session-attendance record will be used to record fidelity.
Intervention code [1] 324196 0
Rehabilitation
Comparator / control treatment
Cohort comparator group: Following a comprehensive occupational therapy assessment of work ability, participants will be observed for 24 weeks post-consent. All participants enrolled in the cohort study will be invited to be randomised into the trial. and those participants enrolled in the cohort study who choose not to be randomised into the trial will form this comparator group.
Standard care will include clinical rehabilitation available to adults who have suffered a stroke, including physiotherapy, occupational therapy, speech pathology, and/or clinical and/or neuropsychology, This is generally offered via Community Rehabilitation Programs (state-based rehabilitation services) and private practitioners (funded by private health insurance as relevant). Therapy / processes that may be offered to these participants will be stroke rehabilitation as detailed in the Stroke Foundation Clinical Guidelines.
Control group
Active

Outcomes
Primary outcome [1] 332231 0
Participation in work as reported by the participant in hours worked over past week.
Timepoint [1] 332231 0
24 weeks post-intervention commencement
Secondary outcome [1] 412649 0
Health-related quality of life as measured using the EQ5D5L
Timepoint [1] 412649 0
24 weeks post-intervention commencement
Secondary outcome [2] 412650 0
Work self-efficacy as measured using the Work and Social Adjustment Measure
Timepoint [2] 412650 0
24 weeks post-intervention commencement
Secondary outcome [3] 412651 0
Fatigue as measured using the Fatigue Severity Scale
Timepoint [3] 412651 0
24 weeks post-intervention commencement
Secondary outcome [4] 412788 0
Feasibility of intervention programs as measured by an audit of the study records, including enrolment, withdrawal and attendance logs.
Timepoint [4] 412788 0
24 weeks post-intervention commencement
Secondary outcome [5] 412789 0
Adverse events will be collected prospectively using adverse events reporting form, this will include serious and unexpected adverse events. Possible adverse events will include hospital admissions and workplace accidents requiring medical attention, increase in cognitive fatigue which necessitates medical attention (GP visit), or increase in post-stroke depression which necessitates medical or psychological attention.
Timepoint [5] 412789 0
Collected across the intervention period (from the commencement of intervention to 24 weeks post-intervention commencement).

Eligibility
Key inclusion criteria
- Clinically diagnosed stroke of >4-weeks to <12-months history;
- Employed, self-employed, in full-time education or voluntary work at the time of stroke with nil plans to retire within 6 months;
- Sufficient proficiency in English to contribute to the data collection required for research;
- Working less than 80% of pre-stroke hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants with a history of pre-existing neuropsychological disorder resulting in cognitive impairment not likely to respond to rehabilitation (e.g., vascular dementia, Alzheimer disease, schizophrenia, brain injury).

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)
A centralised computer-generated randomisation system will be provided by an unblinded independent statistician (CI Farrin), using minimisation with a random element, minimised by centres, education level and work status at baseline assessment (employed / unemployed).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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, for estimating implementation elements and assessing the primary and quantitative secondary outcomes (clinical, feasibility, completion). Adverse events will be monitored throughout and compared across intervention 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 differences in outcomes between cohort control and intervention groups. To generate evidence of proof of principle, we will generate a range of confidence intervals around the main estimates for the treatment effect; all analyses will adjust for key predictors of job type, pre-stroke hours of work and, stroke severity

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2022
Actual
Date of last participant enrolment
Anticipated
14/07/2024
Actual
Date of last data collection
Anticipated
29/12/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 22920 0
Caulfield Hospital - Caulfield
Recruitment hospital [2] 22921 0
The Alfred - Melbourne
Recruitment hospital [3] 22922 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 22923 0
Sacred Heart Hospice - Darlinghurst
Recruitment postcode(s) [1] 38229 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 38227 0
3004 - Melbourne
Recruitment postcode(s) [3] 38226 0
3162 - Caulfield
Recruitment postcode(s) [4] 38228 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 311994 0
Government body
Name [1] 311994 0
Department of Health, Medical Research Futures Fund (MRFF) Cardiovascular Health Mission
Country [1] 311994 0
Australia
Primary sponsor type
University
Name
Monash University
Address
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 313489 0
None
Name [1] 313489 0
None
Address [1] 313489 0
None
Country [1] 313489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311416 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 311416 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 311416 0
Australia
Date submitted for ethics approval [1] 311416 0
Approval date [1] 311416 0
06/07/2022
Ethics approval number [1] 311416 0
81612 [NMA] / Alfred 16/22

Summary
Brief summary
There is an acknowledged lack of available specialist vocational rehabilitation services for adults with stroke. This trial-within-a-cohort will investigate the effectiveness of two models shown to be effective outside of Australia: (1) a resource facilitation approach which will support existing clinical rehabilitation teams to address return-to-work goals, and (2) a more intensive specialist rehabilitation model where a central team of expert clinicians will provide the rehabilitation. The aim is to determine whether a model of vocational rehabilitation will support returning to work after stroke more than clinical rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121018 0
Prof Natasha Lannin
Address 121018 0
Department of Neuroscience
Monash University
99 Commercial Rd, Melbourne VIC 3004
Country 121018 0
Australia
Phone 121018 0
+61 3 9903 0555
Fax 121018 0
Email 121018 0
natasha.lannin@monash.edu
Contact person for public queries
Name 121019 0
Prof Natasha Lannin
Address 121019 0
Department of Neuroscience
Monash University
99 Commercial Rd, Melbourne VIC 3004
Country 121019 0
Australia
Phone 121019 0
+61 3 9903 0555
Fax 121019 0
Email 121019 0
natasha.lannin@monash.edu
Contact person for scientific queries
Name 121020 0
Prof Natasha Lannin
Address 121020 0
Department of Neuroscience
Monash University
99 Commercial Rd, Melbourne VIC 3004
Country 121020 0
Australia
Phone 121020 0
+61 3 9903 0555
Fax 121020 0
Email 121020 0
natasha.lannin@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical clearance for IPD was not obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16844Study protocol  natasha.lannin@monash.edu Study protocol may be obtained from the chief inve... [More Details]
16845Statistical analysis plan  natasha.lannin@monash.edu
16846Informed consent form  natasha.lannin@monash.edu Copy of the informed consent form may be obtained ... [More Details]
16847Ethical approval  natasha.lannin@monash.edu Copy of the ethical approval certificate may be ob... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.