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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|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)|
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.
|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|
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.
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.
Individualised, tailored work advice and work/vocational rehabilitation, including self-management and job modifications.
- 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
- 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.
- Work status [ Time Frame: Change between 0 and 12 months ]Options are whether in full- or part-time work; early retired; retired; unemployed
- Absenteeism [ Time Frame: Monthly for 12 months ]Number of days sick leave/month. Total number of sick days over 12 month period is calculated.
- Work Self-Efficacy Scale [ Time Frame: Change 0 to 12 months ]Confidence about working; 0-10 scale; higher scores indicate greater confidence
- 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
- Short Form-12 (SF-12) Health Survey [ Time Frame: Change 0 to 12 months ]Physical and mental health.
- EuroQol Five Dimensions QuestionnaireEQ5DL-5 [ Time Frame: Change 0 to 12 months. ]Quality of Life Scale
- 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.
- 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.
- 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)
- 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
- The Work Transitions Index [ Time Frame: Change 0 to 12 months ]Work disruptions due to arthritis
- 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
- 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
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
|Contact: Alison Hammond, PhD||0161 295 email@example.com|
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|Principal Investigator:||Alison Hammond, BSc(Hons)PhD||University of Salford|