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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

19/10/2024

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]

GNT2008141

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

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]

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]

Participation in work as reported by the participant in hours worked over past week.

Timepoint [1]