A Tailored Occupational Therapist–Led Vocational Intervention for People With Stroke: Protocol for a Pilot Randomized Controlled Trial

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: This paper presents a protocol that outlines the steps that will be undertaken to pilot both the intervention and trial processes for the Work trial. METHODS: The Work trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. A total of 54 adults of working age who have experienced a stroke <4 months prior will be randomized 1:1 to either (1) an experimental group who will receive a 12-week early vocational intervention (Work intervention) plus usual clinical rehabilitation or (2) a 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 the 3- and 6-month follow-ups. Process evaluation using data collected during the study, as well as postintervention individual interviews with participants and surveys with trial therapists, will complement quantitative data. CONCLUSIONS: The results of the trial will provide details on 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 to determine the clinical effectiveness of vocational rehabilitation when delivered in the early subacute phase of stroke recovery. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001164189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378112&isReview=true INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40548