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Trial record 70 of 1224 for:    arthritis+management

WORKWELL: Testing Work Advice for People With Arthritis (WORKWELL)

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ClinicalTrials.gov Identifier: NCT03942783
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
University of Central Lancashire
University of Manchester
Versus Arthritis
Information provided by (Responsible Party):
Alison Hammond, University of Salford

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 months, with cost-effectiveness analysis.

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.


Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis, Inflammatory Other: WORKWELL Other: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Job Retention Vocational Rehabilitation for Employed People With Inflammatory Arthritis: the WORKWELL Trial.
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group

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
Published arthritis work booklets;written guidance on work problem identification; potential actions
Other Name: written work self-help information pack

Experimental: WORKWELL Group
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.
Other Names:
  • Vocational rehabilitation
  • Work rehabilitation




Primary Outcome Measures :
  1. Combined Work Activities Limitations Scale - Work Limitations Questionnaire-25 [ Time Frame: Change between 0 to 12 months ]
    Measure of presenteeism (i.e. productivity at work). Scale range 0-111Higher values indicate worse outcome


Secondary Outcome Measures :
  1. Rheumatoid Arthritis Work Instability Scale [ Time Frame: Change 0 to 12 months ]
    Measure of the degree of mismatch between functional abilities and workplace demands. Scale range 0-23. Higher scores indicate worse problems.

  2. Work status [ Time Frame: Change between 0 and 12 months ]
    Options are whether in full- or part-time work; early retired; retired; unemployed

  3. Absenteeism [ Time Frame: Monthly for 12 months ]
    Number of days sick leave/month. Total number of sick days over 12 month period is calculated.

  4. Work Self-Efficacy Scale [ Time Frame: Change 0 to 12 months ]
    Confidence about working; 0-10 scale; higher scores indicate greater confidence

  5. Work Productivity and Activity Impairment Scale [ Time Frame: Change 0 to 12 months ]

    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


  6. Short Form-12 (SF-12) Health Survey [ Time Frame: Change 0 to 12 months ]
    Physical and mental health.

  7. EuroQol Five Dimensions QuestionnaireEQ5DL-5 [ Time Frame: Change 0 to 12 months. ]
    Quality of Life Scale

  8. Rheumatoid Arthritis Impact of Disease Scale [ Time Frame: Change 0 to 12 months ]

    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.


  9. RA Disease Activity Index-5 [ Time Frame: Change 0 to 12 months ]
    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.

  10. Health Resource Use Questionnaire [ Time Frame: cumulative health recourse use over 12 months ]
    Measure of health resource use (secondary and primary care; social care; private health care)


Other Outcome Measures:
  1. The Perceived Workplace Support Scale [ Time Frame: Change 0 to 12 months ]
    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

  2. The Work Transitions Index [ Time Frame: Change 0 to 12 months ]
    Work disruptions due to arthritis

  3. Work-Health - Personal Life Perceptions Scale: short form [ Time Frame: Change 0 to 12 months ]
    Ability to balance demands of work, health and personal life. Score range 4 - 16, higher score indicates worse balance

  4. The Workplace Accommodations, Benefits, Policies and Practices Scale [ Time Frame: Change 0 to 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942783


Contacts
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Contact: Alison Hammond, PhD 0161 295 0038 a.hammond@salford.ac.uk
Contact: Angela Ching, PhD 0161 295 6979 a.ching@salford.ac.uk

Locations
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United Kingdom
North Bristol NHS Trust Not yet recruiting
Bristol, Avon, United Kingdom, BS10 5NB
Contact: Jennifer Philpott, BSc(HOns)    0117 414 1683    Jennifer.Philpott@nbt.nhs.uk   
Contact: Wendy Wilmott, RN    0117 3232399    wendy.wilmott@nhs.net   
Principal Investigator: Jennifer Philpott, BSc(Hons)         
Countess of Chester Hospital NHS Foundation Trust Not yet recruiting
Chester, Cheshire, United Kingdom, CH2 1UL
Contact: Kate Dulson, BSc(Hons)    01244 365334    kate.dulson@nhs.net   
Contact: Helen Jeffrey, RN    01244 363337    helenjeffrey1@nhs.net   
Principal Investigator: Kate Dulson, BSc(Hons)         
Newcastle Upon Tyne Hospitals NHS Trust. Not yet recruiting
Newcastle Upon Tyne, Co Tyne And Wear, United Kingdom, NE7 7DN
Contact: Ben Thompson, MD    0191 2231853    ben.thompson@nuth.nhs.uk   
Contact: Sarah Grant, BSc(Hons)    0191 2131685    sarah.grant3@nuth.nhs.uk   
Principal Investigator: Ben Thompson, MD         
Northern Devon Healthcare NHS Trust Not yet recruiting
Barnstaple, Devon, United Kingdom, EX31 4JB
Contact: Joanna Harness, BSc(Hons)    01271 311680    joanna.harness@nhs.net   
Contact: Jane Hunt, RN    01271 311610    Jane.hunt9@nhs.net   
Principal Investigator: Joanna Harness, BSc(Hons)         
NHS Fife Not yet recruiting
Kirkcaldy, Fife, United Kingdom, KY1 2ND
Contact: Janet Harkess, BSc(Hons)    01592 648193 ext 20769    janetharkess@nhs.net   
Contact: Claire Stewart, RN    01383 623623 ext 20944    Claire.stewart18@nhs.net   
Principal Investigator: Janet Harkess, BSc(Hons)         
Manchester University NHS Foundation Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9WL
Contact: Janet Perkins, BSc(Hons)    0161 291 2110    Janet.perkins@mft.nhs.uk   
Contact: JoAnn Nicholson, RN    0161 276 7936    JoAnn.nicholson@mft.nhs.uk   
Principal Investigator: Janet Perkins, BSc(Hons)         
Salford Royal NHS Foundation Trust Not yet recruiting
Salford, Greater Manchester, United Kingdom, M6 8HD
Contact: Terence O'Neill, MD    0161 306 0547    terence.o'neill@manchester.ac.uk   
Contact: Nicola Harwood, RN    0161 206 6077    Nicola.harwood@srft.nhs.uk   
Principal Investigator: Terence O'Neill, MD         
St Helens and Knowsley Teaching Hospitals NHS Trust Recruiting
St Helens, Merseyside, United Kingdom, WA9 3DA
Contact: Yvonne Hough, DipCOT    01744 646454    Yvonne.hough@sthk.nhs.uk   
Contact: Denise Graham, RN    01744 646205    Denise.graham@sthk.nhs.uk   
Principal Investigator: Yvonne Hough         
Aneurin Bevan University Health Board Recruiting
Chepstow, Monmouthshire, United Kingdom, NP16 5YX
Contact: Diane Webb, BSc(Hons)    01291 636664    diane.webb@wales.nhs.uk   
Contact: Melinda Robinson, BSc(Hons)    01633 238246    Melinda.robinson@wales.nhs.uk   
Principal Investigator: Diane Webb, BSc(Hons)         
Northumbria Healthcare NHS Foundation Trust Not yet recruiting
Hexham, Northumberland, United Kingdom, NE46 1QJ
Contact: Anne Boulton, BSc(Hons)    01434 655632    Anne.boulton@nhct.nhs.uk   
Contact: Rachel Browell, RN    0344 811 8111 ext 334561    Rachel.browell@northumbria-healthcare.nhs.uk   
Principal Investigator: Anne Boulton, BSc(HOns)         
Sherwood Forest Hospitals NHS Foundation Trust Recruiting
Sutton In Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
Contact: David Walsh, PhD    0115 823 1766    David.walsh@nottingham.ac.uk   
Contact: Deborah Wilson, RN    01623 672533    Deborah.wilson21@nhs.net   
Principal Investigator: David Walsh, PhD         
Oxford University Hospitals NHS Foundation Trust Not yet recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7HE.
Contact: Clare McKenzie, BSc(Hons)    01865 737526    clare.mckenzie@ouh.nhs.uk   
Contact: Jacqueline Sherwood, BSc(Hons)    01865 737551    Jacqueline.sherwood@ouh.nhs.uk   
Principal Investigator: Clare McKenzie, BSc(Hons)         
The Royal Wolverhampton NHS Trust Not yet recruiting
Cannock, Staffordshire, United Kingdom, WS11 5XY
Contact: Jill Spicer, BSc(Hons)    01543 576411    jill.spicer@nhs.net   
Contact: Julie Edwards, RN    01543 576449    Julie.edwards26@nhs.net   
Principal Investigator: Jill Spicer, BSc(Hons)         
Cardiff and Vale UHB: LLandough Hospital Recruiting
Cardiff, Vale Of Glamorgan, United Kingdom, CF64 2XX
Contact: Sally Green, BSc(Hons)    029 20715578    Sally.green@wales.nhs.uk   
Contact: Wendy Wade    029 2074 2028    Wendy.Wade@wales.nhs.uk   
Principal Investigator: Sally Green, BSc(Hons)         
Royal United Hospitals Bath NHS Foundation Trust Recruiting
Bath, Wiltshire, United Kingdom, BA1 1RL
Contact: Sandi Derham, MSc    01225 473416    s.derham@nhs.net   
Contact: Suzanne Green, BSc(Hons)    01225 473410    Suzanne.greeen1@nhs.net   
Principal Investigator: Sandi Derham, MSc         
Worcestershire Acute Hospitals NHS Trust Not yet recruiting
Worcester, Worcestershire, United Kingdom, WR5 1DD
Contact: Alison Hinton, BSc(Hons)    01905 760462    alison.hinton1@nhs.net   
Contact: Jessica Thrush, RN    01905 760825 ext 38797    jessicathrush@nhs.net   
Principal Investigator: Alison Hinton, BSc(Hons)         
Barnsley Hospitals NHS Foundation Trust Recruiting
Barnsley, Yorkshire, United Kingdom, S75 2EP
Contact: Ursula McFarlane, BSc(Hons)    01226 432736    ursula.macfarlane@.nhs.net   
Contact: Nicola Lancaster, RN    01226 432520    Nicola.lancaster2@nhs.net   
Principal Investigator: Ursula McFarlane, BSc(Hons)         
The Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, Yorkshire, United Kingdom, LS7 4SA
Contact: Julia Rushworth, BSc(Hons)    0113 3924528    julia.rushworth@nhs.net   
Contact: Laura Kelly, BSc    0113 392 0302    Laura.kelly8@nhs.net   
Principal Investigator: Julia Rushworth, BSc(Hons)         
Sponsors and Collaborators
University of Salford
University of Central Lancashire
University of Manchester
Versus Arthritis
Investigators
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Principal Investigator: Alison Hammond, BSc(Hons)PhD University of Salford

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Responsible Party: Alison Hammond, Professor Alison Hammond, University of Salford
ClinicalTrials.gov Identifier: NCT03942783     History of Changes
Other Study ID Numbers: UoSWORKWELL1.1
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: UK Work Environment Survey (work assessment: already open access). Workwell Solutions Manual to be shared at end of trial (open access).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: At end of trial.
Access Criteria: Application to study team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alison Hammond, University of Salford:
work rehabilitation
vocational rehabilitation
occupational therapy
rehabilitation
presenteeism
employment

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases