An interventional study of WORKWELL and Control in Arthritis, Rheumatoid, Arthritis, Psoriatic and Arthritis, Inflammatory, sponsored by University of Salford. Completed at 18 sites in United Kingdom. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by University of Salford · Not applicable, Interventional, and Treatment
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.
Background Work problems are common in people with inflammatory arthritis (IA). In rheumatoid arthritis (RA) 33% stop working within two years and 50% within 10 years. Work difficulties include: pain (particularly hand pain); fatigue; unadapted work environments, equipment and work schedules; poor work self-efficacy (i.e. lack of confidence about working); job strain; limited use of self-management strategies; and limited support from employers and work colleagues. Two USA trials of brief (3 hours) job retention vocational rehabilitation (VR) identified job loss was postponed by modifying such factors. A UK proof-of-principle trial (n=32) identified 10 hours (minimum) of VR reduced work instability. VR is not routinely available in the NHS and Rheumatology departments. It is unclear from the evidence if brief VR provided by therapists is effective and cost-effective in the UK.
Aims
Design A pragmatic, multi-centre individually randomised controlled trial (RCT) comparing the effects of brief VR (intervention) with written self-help advice only (control). Cost-effectiveness and process evaluations will also be conducted.
Methodology Employed people with RA/ UIA/ PsA who have concerns about being able to continue to work in future due to arthritis, will be consented into the study. They will complete a baseline questionnaire (hard copy or online according to participant preference) and will then be randomly allocated in equal numbers, stratified by participants' job skill levels, to either intervention or control groups. Participants (in both groups) will be mailed a self-help work information pack. Participants' in the intervention group will be referred to receive the WORKWELL intervention from a trained occupational therapist/ physiotherapist. The Lancashire Clinical Trials Unit (CTU: University of Central Lancashire) will contact participants monthly by text/ e-mail/ telephone to identify numbers of days on sick leave. Six months after completing the baseline questionnaire, participants will complete a short postal/online questionnaire including presenteeism, productivity health status measures and resource data. At 12 months, participants will complete a third postal/online questionnaire with most of the measures collected at baseline. Two sub-samples from the intervention and control groups will be interviewed: employed participants about their views of VR; and any unemployed/ retired due to ill-health participants about factors contributing to job loss. At 36 months, participants will complete a fourth postal/online questionnaire with some of the key work status measures collected at baseline. Two sub-samples from the intervention and control groups will be interviewed: employed participants about their views of VR; and any unemployed/ retired due to ill-health participants about factors contributing to job loss.
Planned Sample Size 240 people will be recruited from 18 sites. On completion of the trial, qualitative interviews will be completed with 15 employed participants and up to 7 (if any) unemployed / early retired through ill-health from the intervention group. WORKWELL participants' line managers/employers will also be interviewed (where possible: n=10). WORKWELL Therapists and their line managers will also be interviewed (one each from each site, or less if data saturation is reached (n=18 for each).
Analyses Statistical analyses will investigate differences in outcomes at 12 and 36 months after baseline between intervention and control groups using mixed effects linear, logistic or ordinal logistic regression modelling, adjusted for baseline values and stratification variables (as applicable). The primary outcome is the summed score of the Combined Work Activities Limitations Scale -Work Limitations Questionnaire-25 (a measure of work presenteeism) at 12 and 36 months after baseline assessment. The health economic analysis will be conducted from the UK National Health Service (NHS) and employer perspectives. Interviews will be thematically analysed. Records will be analysed using content analysis.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 249 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →University of Salford is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will receive a written work self-help information pack plus usual care. The pack includes published arthritis patient information booklets about work; a decision-tree flowchart; information about the UK Equality Act. The self-help information pack is mailed to the participants by the CTU following randomisation. Usual care consists of: prescribed medication; attending Rheumatology clinics; referral to rehabilitation, as and when deemed necessary from the Rheumatology clinic, but not including work advice. Any rehabilitation required will be provided as normal, e.g. provision of exercise, self-management education, activities of daily living advice, psychosocial support.
Other: Control
The same as the Control Group (i.e. self-help information pack, plus usual care) PLUS the WORKWELL intervention. This consists of, on average, 4.5 hours contact, including: a structured work assessment; identification of work-related barriers and priority problems; collaborative treatment planning with the participant; a range of self-management, work advice and job modifications appropriate to the individual participant's problems; goal setting and action planning; and a 30 minute telephone review to identify progress with goals at the end of treatment.
Other: WORKWELL
Individualised, tailored work advice and work/vocational rehabilitation, including self-management and job modifications.
Also known as: Vocational rehabilitation, Work rehabilitation
Published arthritis work booklets;written guidance on work problem identification; potential actions
Also known as: written work self-help information pack
Combined Work Activities Limitations Scale - Work Limitations Questionnaire-25
Measure of presenteeism (i.e. productivity at work). Scale range 0-111Higher values indicate worse outcome
Time frame: Change between 0 to 12 months; 0 to 36 months
Rheumatoid Arthritis Work Instability Scale
Measure of the degree of mismatch between functional abilities and workplace demands. Scale range 0-23. Higher scores indicate worse problems.
Time frame: Change 0 to 12 months
Work status
Options are whether in full- or part-time work; early retired; retired; unemployed
Time frame: Change between 0 and 12 months; 0 to 36 months
Absenteeism
Number of days sick leave/month. Total number of sick days over 12 month period is calculated.
Time frame: Monthly for 12 months
Work Self-Efficacy Scale
Confidence about working; 0-10 scale; higher scores indicate greater confidence
Time frame: Change 0 to 12 months
Work Productivity and Activity Impairment Scale
Measures time off on sick leave or for any other reason, hours worked; health problems effect on work productivity and ability to do other daily activities; percentage absenteeism - all in the last 7 days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows: Scoring instructions available at: http://www.reillyassociates.net/WPAI_Scoring.html
Time frame: Change 0 to 12 months
Short Form-12 (SF-12) Health Survey
Physical and mental health.
Time frame: Change 0 to 12 months
EuroQol Five Dimensions QuestionnaireEQ5DL-5
Quality of Life Scale
Time frame: Change 0 to 12 months.
Rheumatoid Arthritis Impact of Disease Scale
Domains of impact of RA: coping, helplessness, fatigue, physical function, sleep, global assessment and pain. RAID final value = (pain NRS value (range 0-10) x 0.21) + (function NRS value (range 0-10) x 0.16) + (fatigue NRS value (range 0-10) x 0.15) + (phys well being NRS value (range 010) x 0.12) + (sleep NRS value (range 0-10) x 0.12) + (emotional well being NRS value (range 0-10) x 0.12) + (coping NRS value (range 0-10) x 0.12). Thus, the range of the final RAID value is 0-10 where higher figures indicate worse status.
Time frame: Change 0 to 12 months
RA Disease Activity Index-5
The RADAI contains five items on global disease activity during the past 6 months (item 1), current disease activity as measured by swollen and tender joints (item 2), current amount of arthritis pain (item 3), current duration of morning stiffness (item 4) and current number of tender joints in a joint list (item 5). The first three items are scored on an 11-point numerical rating scale, with verbal anchors from ''no disease activity''/''no pain'' (score 0) to ''extreme disease activity''/''extreme pain'' (score 10). The last two items are scored on a seven-point (item 4) and four-point (item 5) verbal rating scale.
Time frame: Change 0 to 12 months
Health Resource Use Questionnaire
Measure of health resource use (secondary and primary care; social care; private health care)
Time frame: cumulative health recourse use over 12 months
The Perceived Workplace Support Scale
Perceived level of managerial, co-worker and organisational support available to respondent. Each subscale is scored by adding the scores. Sub-scale a: managerial support score range 4 to 20; co-worker support scale b range 8-40; organisational support scale c score range 7-35. Higher scores indicate less support
Time frame: Change 0 to 12 months
The Work Transitions Index
Work disruptions due to arthritis
Time frame: Change 0 to 12 months;
Work-Health - Personal Life Perceptions Scale: short form
Ability to balance demands of work, health and personal life. Score range 4 - 16, higher score indicates worse balance
Time frame: Change 0 to 12 months
The Workplace Accommodations, Benefits, Policies and Practices Scale
a) The number of job accommodations, policies and workplace practices employees have available in their workplace (range 0 - 17), and b) how helpful they find it helpful each of these to manage health related work difficulties (1 to 5 scale). Higher scores indicate greater level of helpfulness
Time frame: Change 0 to 12 months
Plan to share: Yes — UK Work Environment Survey (work assessment: already open access). Workwell Solutions Manual to be shared at end of trial (open access).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: At end of trial.
Access criteria: Application to study team
Ran from Mar 2019 to primary completion in Apr 2024, 61 months.
Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 61 months is above that.
Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Salford