WORKWELL: Testing Work Advice for People With Arthritis

NCT03942783 | Completed

• 1 other identifier: UoSWORKWELL1.1
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 18

Brief 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. 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.

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Arthritis, Inflammatory

Keywords

work rehabilitation; vocational rehabilitation; occupational therapy; rehabilitation; presenteeism; employment

Outcome Measures

Primary Outcomes (1)

• 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

  Change between 0 to 12 months; 0 to 36 months

Secondary Outcomes (10)

• Rheumatoid Arthritis Work Instability Scale

  Change 0 to 12 months

• Work status

  Change between 0 and 12 months; 0 to 36 months

• Absenteeism

  Monthly for 12 months

• Work Self-Efficacy Scale

  Change 0 to 12 months

• Work Productivity and Activity Impairment Scale

  Change 0 to 12 months

Other Outcomes (4)

• The Perceived Workplace Support Scale

  Change 0 to 12 months

• The Work Transitions Index

  Change 0 to 12 months;

• Work-Health - Personal Life Perceptions Scale: short form

  Change 0 to 12 months

Study Arms (2)

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.

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.

Other: WORKWELL

Interventions

WORKWELL OTHER

Individualised, tailored work advice and work/vocational rehabilitation, including self-management and job modifications.

Also known as: Vocational rehabilitation, Work rehabilitation

WORKWELL Group

Control OTHER

Published arthritis work booklets;written guidance on work problem identification; potential actions

Also known as: written work self-help information pack

Control Group

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salford: lead
• University of Central Lancashire: collaborator
• University of Manchester: collaborator
• Versus Arthritis: collaborator

Study Sites (18)

North Bristol NHS Trust

Bristol, Avon, BS10 5NB, United Kingdom

Location

Countess of Chester Hospital NHS Foundation Trust

Chester, Cheshire, CH2 1UL, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust.

Newcastle upon Tyne, Co Tyne and Wear, NE7 7DN, United Kingdom

Location

Northern Devon Healthcare NHS Trust

Barnstaple, Devon, EX31 4JB, United Kingdom

Location

NHS Fife

Kirkcaldy, Fife, KY1 2ND, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

St Helens and Knowsley Teaching Hospitals NHS Trust

St Helens, Merseyside, WA9 3DA, United Kingdom

Location

Aneurin Bevan University Health Board

Chepstow, Monmouthshire, NP16 5YX, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Hexham, Northumberland, NE46 1QJ, United Kingdom

Location

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7HE., United Kingdom

Location

The Royal Wolverhampton NHS Trust

Cannock, Staffordshire, WS11 5XY, United Kingdom

Location

Cardiff and Vale UHB: LLandough Hospital

Cardiff, Vale of Glamorgan, CF64 2XX, United Kingdom

Location

Royal United Hospitals Bath NHS Foundation Trust

Bath, Wiltshire, BA1 1RL, United Kingdom

Location

Worcestershire Acute Hospitals NHS Trust

Worcester, Worcestershire, WR5 1DD, United Kingdom

Location

Barnsley Hospitals NHS Foundation Trust

Barnsley, Yorkshire, S75 2EP, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, LS7 4SA, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 40124973 BACKGROUND

• Hammond 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.

  PMID: 32912199 BACKGROUND

• Sutton C, Cotterill S, Forshaw D, Rhodes S, Haig A, Hammond A. SWAT 86 evaluation: Randomised evaluation of prenotification of trial participants before self-report outcome data collection to improve retention. Research Methods in Medicine and Health Sciences 2022 3(4): 107-115 https://doi.org/10.1177/26320843221098427

  BACKGROUND

• Hammond 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.

  PMID: 36352479 BACKGROUND

• Ching 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.

  PMID: 36539794 BACKGROUND

• Hammond 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.

  PMID: 40022440 DERIVED

• Hammond 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.

  PMID: 37876334 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Arthritis

Interventions

Rehabilitation, Vocational

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yeliz Prior, PhD

  University of Salford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigators will remain blinded to group allocation until the participant has completed and returned their baseline questionnaire, and the data verified at the Lancashire CTU. Data co-ordination staff at the CTU, who will be responsible for contacting patients to obtain missing data from 6- and 12-month questionnaires will be blinded to group allocation. The Data Manager and Information Systems team will be unblinded. Due to the nature of the intervention it will not be possible for therapists to be blinded to group allocation. Participants cannot be blinded to the intervention they receive. The statistician will be blinded to group allocation by using a dummy variable for group allocation until analysis is complete. The health economist will not be blinded as the costs of WORKWELL will need to be included into the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Yeliz Prior

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: May 8, 2019
• Study Start: March 22, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At end of trial.
• Access Criteria: Application to study team

Locations

GB (18)