Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 27, 2022
Date Accepted: Aug 18, 2022
An occupational therapist-led vocational intervention for people with stroke: study protocol for a single-centre individually-randomised controlled pilot trial
ABSTRACT
Background:
Resuming work after stroke is a common goal of working-age adults, yet there are few vocational rehabilitation programs designed to address the unique challenges faced following stroke. The Work intervention was developed to address these gaps.
Objective:
To pilot both the intervention and trial processes for the Work trial.
Methods:
The Work trial is a two-arm prospective randomized, blinded-assessor study design with intention to treat analysis. Fifty-four adults of working age who have experienced a stroke <4 months prior, will be randomized 1:1 to either (i) experimental group who will receive a 12-week early vocational intervention (Work intervention) plus usual clinical rehabilitation, or (ii) control group who will receive only their usual clinical rehabilitation.
Results:
Outcomes include study and intervention feasibility and intervention benefit. In addition to evaluating the feasibility of delivering vocational intervention early after stroke, benefit will be assessed by measuring rates of vocational participation and quality of life improvements at 3- and 6-months follow-up. Process evaluation using data collected during the study, as well as post-intervention individual interviews with participants and surveys with trial therapists will complement quantitative data.
Conclusions:
The results of the trial will provide details of the feasibility of delivering the Work intervention embedded within the clinical rehabilitation context and inform future trial processes. Pilot data will enable a future definitive trial so as to determine the clinical effectiveness of vocational rehabilitation when delivered in the early sub-acute phase of stroke recovery. Clinical Trial: www.anzctr.og.au ACTRN12619001164189, Date registered 20/08/2019
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