NCT03942783Completed
WORKWELL: Testing Work Advice for People With Arthritis
A Randomised Controlled Trial of Job Retention Vocational Rehabilitation for Employed People With Inflammatory Arthritis: the WORKWELL Trial.
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 249 (actual)
- First submitted
- 8 Sept 2018
- Start date
- 22 Mar 2019
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- University of Salford
- Diseases
- Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT03942783
What you commit to
- Study type: Interventional
- Participants enrolled: 249
- From 22 Mar 2019 to the primary completion date, 30 Apr 2024
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- already receiving or awaiting VR services from Access to Work or a Vocational Rehabilitation company. These services conduct work assessments as part of VR provision. (Those receiving work services from other sources (e.g. occupational health or human resources in their organisation, online advice from Fit for Work) may still be recruited as VR provision can be of varied quality and this will be considered as "usual care."
Age
- Already planning to retire due to age or to take early retirement (for any health or non-health reason) within the next 12 months (i.e. within the trial follow-up period)
Other
- on extended sick leave (i.e. \> 4 weeks). The WORKWELL intervention is designed for people currently in work. Long-term sick leave is defined as being \> 4 weeks \[NICE, 2009b\].
- planning to move out of area within the next 3 months and therefore would be unable to attend for WORKWELL sessions if allocated to that group (as treatment may not be completed in time).
- Employed in the armed forces (as they could be stationed overseas during the trial period. The armed services also have their own Vocational Rehabilitation service.
Who the study is looking for
- Adults (i.e. aged ≥ 18 years)
- diagnosed with RA, UIA or PsA by a Rheumatology Consultant. (Undifferentiated Inflammatory Arthritis is defined as: persistent synovitis in more than one small joint of the hand, without any other known cause, but the person does not yet meet all the diagnostic criteria for RA. Participants can have co-morbidities (which may also be related to having RA, UIA or PsA, for example, osteoarthritis, fibromyalgia, heart condition, mild to moderate anxiety or depression; or are unrelated, e.g. diabetes.
- In paid work (full or part-time, self-employed or contractual work) for at least 15 hours per week.
- Participants may be on sick leave at the time of screening BUT this must be for less than 4 weeks duration and not planned or likely to extend for longer than 4 weeks.
- Able to read and understand English.
- Score ≥10 on the RA-Work Instability Scale (RA-WIS), a measure of mismatch between the person's abilities and their job demands.
- Able to attend the participating site for WORKWELL appointments, if allocated to that group
- Able to provide informed consent.
Age in the registry: 18 years to 68 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barnsley Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Barnsley | United Kingdom | Unknown status |
| Northern Devon Healthcare NHS Trust Coordinator of this site? Confirm its status | Barnstaple | United Kingdom | Unknown status |
| Royal United Hospitals Bath NHS Foundation Trust Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| North Bristol NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| The Royal Wolverhampton NHS Trust Coordinator of this site? Confirm its status | Cannock | United Kingdom | Unknown status |
| Cardiff and Vale UHB: LLandough Hospital Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Aneurin Bevan University Health Board Coordinator of this site? Confirm its status | Chepstow | United Kingdom | Unknown status |
| Countess of Chester Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Chester | United Kingdom | Unknown status |
| Northumbria Healthcare NHS Foundation Trust Coordinator of this site? Confirm its status | Hexham | United Kingdom | Unknown status |
| NHS Fife Coordinator of this site? Confirm its status | Kirkcaldy | United Kingdom | Unknown status |
| The Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Newcastle-upon-Tyne Hospitals NHS Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Salford Royal NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| St Helens and Knowsley Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | St Helens | United Kingdom | Unknown status |
| Sherwood Forest Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Unknown status |
| Worcestershire Acute Hospitals NHS Trust Coordinator of this site? Confirm its status | Worcester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.