Arthritis, RheumatoidWORKWELLNCT03942783
WORKWELL: Testing Work Advice for People With Arthritis
A study testing WORKWELL in people with Arthritis, Rheumatoid and Arthritis, Psoriatic, run by University of Salford at 18 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Arthritis, Inflammatory
- What is being tested?
- WORKWELL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- 22 Mar 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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].
- 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)
- 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).
- 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."
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United Kingdom18 sites
Barnsley Hospitals NHS Foundation Trust
Barnsley, Yorkshire, S75 2EP
Northern Devon Healthcare NHS Trust
Barnstaple, Devon, EX31 4JB
Royal United Hospitals Bath NHS Foundation Trust
Bath, Wiltshire, BA1 1RL
North Bristol NHS Trust
Bristol, Avon, BS10 5NB
The Royal Wolverhampton NHS Trust
Cannock, Staffordshire, WS11 5XY
Cardiff and Vale UHB: LLandough Hospital
Cardiff, Vale of Glamorgan, CF64 2XX
Aneurin Bevan University Health Board
Chepstow, Monmouthshire, NP16 5YX
Countess of Chester Hospital NHS Foundation Trust
Chester, Cheshire, CH2 1UL
Northumbria Healthcare NHS Foundation Trust
Hexham, Northumberland, NE46 1QJ
NHS Fife
Kirkcaldy, Fife, KY1 2ND
The Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS7 4SA
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Newcastle Upon Tyne Hospitals NHS Trust.
Newcastle upon Tyne, Co Tyne and Wear, NE7 7DN
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7HE.
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
St Helens and Knowsley Teaching Hospitals NHS Trust
St Helens, Merseyside, WA9 3DA
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, Nottinghamshire, NG17 4JL
Worcestershire Acute Hospitals NHS Trust
Worcester, Worcestershire, WR5 1DD
About this study
Official title: A Randomised Controlled Trial of Job Retention Vocational Rehabilitation for Employed People With Inflammatory Arthritis: the WORKWELL Trial.
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.
Read the detailed description
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
- Assess if there is a difference in work presenteeism between people with RA, undifferentiated IA (UIA) or psoriatic arthritis (PsA) who receive either: usual care, written work self-help information plus brief VR (WORKWELL) provided by a therapist trained in providing VR; or usual care and written work self-help information only (WP1).
- To assess if there are differences in self-reported work instability, work, activity limitations, work productivity, absenteeism, work status, work self-efficacy, health status, NHS and societal costs between people receiving WORKWELL or written work self-help information only (WP1)
- To assess the cost-effectiveness of WORKWELL from the perspective of: the NHS using health-related quality of life as the primary outcome; the employer using presenteeism as the primary outcome; and the employer using health-related quality of life as the primary outcome and including presenteeism as a cost. (WP5)
- To update and evaluate a VR programme for occupational therapists and physiotherapists to help them keep people with RA, IA or PsA in work (WP2).
- To measure fidelity to the WORKWELL intervention (WP3).
- To understand the social and structural context in which the intervention is delivered and to identify factors which may influence the quality of implementation (WP3).
- Investigate contextual factors influencing participants' presenteeism (WP4).
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.
- Being tested
- WORKWELL, Control
- Keywords
- work rehabilitation, vocational rehabilitation, occupational therapy, rehabilitation, presenteeism, employment
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WORKWELLOther
Also called Vocational rehabilitation, Work rehabilitation
Individualised, tailored work advice and work/vocational rehabilitation, including self-management and job modifications.
ControlOther
Also called written work self-help information pack
Published arthritis work booklets;written guidance on work problem identification; potential actions
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Control |
| WORKWELL Group | Experimental | 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. Receives: Other: WORKWELL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between 0 to 12 months; 0 to 36 months
Secondary outcomes (10)
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.
Measured: Change 0 to 12 months
Work status
Options are whether in full- or part-time work; early retired; retired; unemployed
Measured: 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.
Measured: Monthly for 12 months
Work Self-Efficacy Scale
Confidence about working; 0-10 scale; higher scores indicate greater confidence
Measured: 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
Measured: Change 0 to 12 months
Short Form-12 (SF-12) Health Survey
Physical and mental health.
Measured: Change 0 to 12 months
EuroQol Five Dimensions QuestionnaireEQ5DL-5
Quality of Life Scale
Measured: 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.
Measured: 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.
Measured: Change 0 to 12 months
Health Resource Use Questionnaire
Measure of health resource use (secondary and primary care; social care; private health care)
Measured: cumulative health recourse use over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start22 Mar 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The WORKWELL trial is a definitive, pragmatic, patient-blinded, multi-centre superiority randomised parallel group trial of: a) WORKWELL compared to b) written work self-help advice in people with RA, UIA or PsA. Both groups will continue to receive usual care. The primary endpoint is the summed score of the Work Limitations Questionnaire-25 (a measure of work presenteeism) at 12 months after baseline assessment. 2022 update: An extension to the study had been approved to complete a 36 month follow-up.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Lancashire, University of Manchester, Versus Arthritis
- Responsible party
- Principal investigator, Yeliz Prior, University of Salford
- Investigators
- Yeliz Prior, PhD, Principal investigator, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942783
- Sponsor's protocol ID
- UoSWORKWELL1.1
- Acronym
- WORKWELL
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2018
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: UK Work Environment Survey (work assessment: already open access). Workwell Solutions Manual to be shared at end of trial (open access).
Publications
Battista S, Parker J, Ching A, Culley J, Long S, Heard A, Hammond A, Radford K, Holland P, O'Neill T, Walker-Bone K, Prior Y. WORKWELL process evaluation: qualitative data analyses of the participant interviews at 12- and 36-month follow-ups. Rheumatol Adv Pract. 2025 Mar 14;9(2):rkaf034. doi: 10.1093/rap/rkaf034. eCollection 2025.
PubMed 40124973Hammond A, Sutton C, Cotterill S, Woodbridge S, O'Brien R, Radford K, Forshaw D, Verstappen S, Jones C, Marsden A, Eden M, Prior Y, Culley J, Holland P, Walker-Bone K, Hough Y, O'Neill TW, Ching A, Parker J. The effect on work presenteeism of job retention vocational rehabilitation compared to a written self-help work advice pack for employed people with inflammatory arthritis: protocol for a multi-centre randomised controlled trial (the WORKWELL trial). BMC Musculoskelet Disord. 2020 Sep 10;21(1):607. doi: 10.1186/s12891-020-03619-1.
PubMed 32912199Sutton CJ, Cotterill S, Forshaw D, Rhodes S, Haig A, Hammond A. Randomised evaluation of pre-notification of trial participants before self-report outcome data collection to improve retention: SWAT86. Res Methods Med Health Sci. 2022 May 7;3(4):107-115. doi: 10.1177/26320843221098427. eCollection 2022 Sep.
PubMed 41908263Hammond A, Radford KA, Ching A, Prior Y, O'Brien R, Woodbridge S, Culley J, Parker J, Holland P. The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis. Trials. 2022 Nov 9;23(1):937. doi: 10.1186/s13063-022-06871-z.
PubMed 36352479Ching A, Parker J, Haig A, Sutton CJ, Cotterill S, Forshaw D, Culley J, Hammond A. Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the WORKWELL trial due to the impact of the COVID-19 pandemic. Trials. 2022 Dec 20;23(1):1030. doi: 10.1186/s13063-022-06941-2.
PubMed 36539794Hammond A, Parker J, Cotterill S, Sutton C, Mirza S, Ching A, O'Neill TW, Holland F, Marsden A, Holland P, Radford K, Verstappen SMM, Eden M, Dalal G, Battista S, Culley J, Walker-Bone K, Woodbridge S, O-Brien R, Hough Y, Prior Y. The WORKWELL programme: a randomized controlled trial of job retention vocational rehabilitation for people with inflammatory arthritis. Rheumatology (Oxford). 2026 Aug 1;65(8):keag373. doi: 10.1093/rheumatology/keag373.
PubMed 42467833Hammond A, O'Brien R, Woodbridge S, Prior Y, Ching A, Culley J, Parker J. Upskilling Rheumatology Occupational Therapists in Work Rehabilitation: An Evaluation of a Job Retention Vocational Rehabilitation Training Course (the Workwell Trial). Musculoskeletal Care. 2025 Mar;23(1):e70067. doi: 10.1002/msc.70067.
PubMed 40022440Hammond A, O'Brien R, Woodbridge S, Parker J, Ching A. The Work Experience Survey - Rheumatic conditions (United Kingdom): Psychometric properties and identifying the workplace barriers of employed people with inflammatory arthritis receiving vocational rehabilitation. Musculoskeletal Care. 2023 Dec;21(4):1578-1591. doi: 10.1002/msc.1835. Epub 2023 Oct 25.
PubMed 37876334
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Job Retention Vocational Rehabilitation for Employed People With Inflammatory Arthritis: the WORKWELL Trial.
- ClinicalTrials.gov ID
- NCT03942783
- Acronym / sponsor ID
- WORKWELL / UoSWORKWELL1.1
- Keywords
- work rehabilitation, vocational rehabilitation, occupational therapy, rehabilitation, presenteeism, employment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- University of Central Lancashire, University of Manchester, Versus Arthritis
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Assess if there is a difference in work presenteeism between people with RA, undifferentiated IA (UIA) or psoriatic arthritis (PsA) who receive either: usual care, written work self-help information plus brief VR (WORKWELL) provided by a therapist trained in providing VR; or usual care and written work self-help information only (WP1).
- To assess if there are differences in self-reported work instability, work, activity limitations, work productivity, absenteeism, work status, work self-efficacy, health status, NHS and societal costs between people receiving WORKWELL or written work self-help information only (WP1)
- To assess the cost-effectiveness of WORKWELL from the perspective of: the NHS using health-related quality of life as the primary outcome; the employer using presenteeism as the primary outcome; and the employer using health-related quality of life as the primary outcome and including presenteeism as a cost. (WP5)
- To update and evaluate a VR programme for occupational therapists and physiotherapists to help them keep people with RA, IA or PsA in work (WP2).
- To measure fidelity to the WORKWELL intervention (WP3).
- To understand the social and structural context in which the intervention is delivered and to identify factors which may influence the quality of implementation (WP3).
- Investigate contextual factors influencing participants' presenteeism (WP4).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The WORKWELL trial is a definitive, pragmatic, patient-blinded, multi-centre superiority randomised parallel group trial of: a) WORKWELL compared to b) written work self-help advice in people with RA, UIA or PsA. Both groups will continue to receive usual care. The primary endpoint is the summed score of the Work Limitations Questionnaire-25 (a measure of work presenteeism) at 12 months after baseline assessment. 2022 update: An extension to the study had been approved to complete a 36 month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: ControlThe 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. |
| WORKWELL Group | Experimental | Other: WORKWELLThe 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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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].
- 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)
- 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).
- 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."
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WORKWELLAlso: Vocational rehabilitation, Work rehabilitationIndividualised, tailored work advice and work/vocational rehabilitation, including self-management and job modifications. | Other | WORKWELL Group |
| ControlAlso: written work self-help information packPublished arthritis work booklets;written guidance on work problem identification; potential actions | Other | Control Group |
Primary outcome
Combined Work Activities Limitations Scale - Work Limitations Questionnaire-25
Time frame: Change between 0 to 12 months; 0 to 36 months
Measure of presenteeism (i.e. productivity at work). Scale range 0-111Higher values indicate worse outcome
10 secondary outcomes
Rheumatoid Arthritis Work Instability Scale
Time frame: Change 0 to 12 months
Work status
Time frame: Change between 0 and 12 months; 0 to 36 months
Absenteeism
Time frame: Monthly for 12 months
Work Self-Efficacy Scale
Time frame: Change 0 to 12 months
Work Productivity and Activity Impairment Scale
Time frame: Change 0 to 12 months
Short Form-12 (SF-12) Health Survey
Time frame: Change 0 to 12 months
EuroQol Five Dimensions QuestionnaireEQ5DL-5
Time frame: Change 0 to 12 months.
Rheumatoid Arthritis Impact of Disease Scale
Time frame: Change 0 to 12 months
RA Disease Activity Index-5
Time frame: Change 0 to 12 months
Health Resource Use Questionnaire
Time frame: cumulative health recourse use over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Results publication: PubMed 40124973Battista S, Parker J, Ching A, Culley J, Long S, Heard A, Hammond A, Radford K, Holland P, O'Neill T, Walker-Bone K, Prior Y. WORKWELL process evaluation: qualitative data analyses of the participant interviews at 12- and 36-month follow-ups. Rheumatol Adv Pract. 2025 Mar 14;9(2):rkaf034. doi: 10.1093/rap/rkaf034. eCollection 2025.
- Results publication: PubMed 32912199Hammond A, Sutton C, Cotterill S, Woodbridge S, O'Brien R, Radford K, Forshaw D, Verstappen S, Jones C, Marsden A, Eden M, Prior Y, Culley J, Holland P, Walker-Bone K, Hough Y, O'Neill TW, Ching A, Parker J. The effect on work presenteeism of job retention vocational rehabilitation compared to a written self-help work advice pack for employed people with inflammatory arthritis: protocol for a multi-centre randomised controlled trial (the WORKWELL trial). BMC Musculoskelet Disord. 2020 Sep 10;21(1):607. doi: 10.1186/s12891-020-03619-1.
- Results publication: PubMed 41908263Sutton CJ, Cotterill S, Forshaw D, Rhodes S, Haig A, Hammond A. Randomised evaluation of pre-notification of trial participants before self-report outcome data collection to improve retention: SWAT86. Res Methods Med Health Sci. 2022 May 7;3(4):107-115. doi: 10.1177/26320843221098427. eCollection 2022 Sep.
- Results publication: PubMed 36352479Hammond A, Radford KA, Ching A, Prior Y, O'Brien R, Woodbridge S, Culley J, Parker J, Holland P. The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis. Trials. 2022 Nov 9;23(1):937. doi: 10.1186/s13063-022-06871-z.
- Results publication: PubMed 36539794Ching A, Parker J, Haig A, Sutton CJ, Cotterill S, Forshaw D, Culley J, Hammond A. Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the WORKWELL trial due to the impact of the COVID-19 pandemic. Trials. 2022 Dec 20;23(1):1030. doi: 10.1186/s13063-022-06941-2.
- Derived from this study: PubMed 42467833Hammond A, Parker J, Cotterill S, Sutton C, Mirza S, Ching A, O'Neill TW, Holland F, Marsden A, Holland P, Radford K, Verstappen SMM, Eden M, Dalal G, Battista S, Culley J, Walker-Bone K, Woodbridge S, O-Brien R, Hough Y, Prior Y. The WORKWELL programme: a randomized controlled trial of job retention vocational rehabilitation for people with inflammatory arthritis. Rheumatology (Oxford). 2026 Aug 1;65(8):keag373. doi: 10.1093/rheumatology/keag373.
- Derived from this study: PubMed 40022440Hammond A, O'Brien R, Woodbridge S, Prior Y, Ching A, Culley J, Parker J. Upskilling Rheumatology Occupational Therapists in Work Rehabilitation: An Evaluation of a Job Retention Vocational Rehabilitation Training Course (the Workwell Trial). Musculoskeletal Care. 2025 Mar;23(1):e70067. doi: 10.1002/msc.70067.
- Derived from this study: PubMed 37876334Hammond A, O'Brien R, Woodbridge S, Parker J, Ching A. The Work Experience Survey - Rheumatic conditions (United Kingdom): Psychometric properties and identifying the workplace barriers of employed people with inflammatory arthritis receiving vocational rehabilitation. Musculoskeletal Care. 2023 Dec;21(4):1578-1591. doi: 10.1002/msc.1835. Epub 2023 Oct 25.
- Individual participant dataSharing planned: Yes. UK Work Environment Survey (work assessment: already open access). Workwell Solutions Manual to be shared at end of trial (open access).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeliz Prior, PhD principal investigator
University of Salford
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WORKWELL in people with Arthritis, Rheumatoid and Arthritis, Psoriatic, run by University of Salford at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Work Activities Limitations Scale - Work Limitations Questionnaire-25 (time frame: Change between 0 to 12 months; 0 to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942783, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.