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Arthritis;Inflammatory clinical trials

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NCT ID: NCT03942783 Active, not recruiting - Clinical trials for Arthritis, Rheumatoid

WORKWELL: Testing Work Advice for People With Arthritis

WORKWELL
Start date: March 22, 2019
Phase: N/A
Study type: Interventional

Background: Inflammatory arthritis (IA) causes work disability, absenteeism (sick leave) and presenteeism (reduced productivity) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) amongst people with IA in the US showed that VR reduced work disability. However, it is unknown whether this approach transfers to the United Kingdom (UK) with a different social and welfare structure. Previously, we modified the VR for the UK, funded by Arthritis Research UK (the WORKWELL programme) and demonstrated it to be deliverable and acceptable in a feasibility trial. Our aim now is to move to the definitive UK trial testing the effectiveness and cost-effectiveness of WORKWELL. Methods: A multicentre randomized controlled trial will be conducted. Employed people with rheumatoid, psoriatic or inflammatory arthritis (n=240), with concerns about continuing working due to arthritis, will be randomized to receive WORKWELL or control (written advice). WORKWELL includes individualised VR (maximum 4.5 hours over several months): assessing work problems; encouraging arthritis self-management in the workplace; addressing ergonomics; considering fatigue and stress management; providing orthoses and educating on employment rights and support services, assistive technology and work modifications. It also includes psychological and disclosure support, workplace visits and employer liaison (as applicable). Outcomes will be assessed at 0, 6 and 12 months by questionnaire. The primary outcome is the Work Limitations Questionnaire-25 (measuring presenteeism: summed score) at 12 and 36 months, with cost-effectiveness analysis at 12 months. Discussion: If effective and cost-effective, WORKWELL can be rolled out in Rheumatology services to help improve the quality and duration of people with arthritis' working lives.