Short summary

This is a a randomised controlled trial to test the efficacy of a six month vocational rehabilitation, WORK-ON, relative to usual care for people with inflammatory arthritis. WORK-ON consists of 1) A coordinating occupational therapist, 2) Group sessions, and 3) individual consultations with physiotherapist, nurse or/and social worker. Primary outcome is work ability measured by the Work Ability Index single item. Secondary outcomes are sick leave and job loss.

Rationale

In Denmark, about 100,000 people are diagnosed with chronic autoimmune inflammatory arthritis (IA). In this study, IA includes rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and psoriatic arthritis (PsA). Despite major advances in pharmacological treatment, there are still unmet needs among people with IA. Many experience pain, fatigue, sleep problems, anxiety, physical disability or problems with participation in everyday activities, including paid work. Up to 40% lose their job in the first years after being diagnosed with IA. Support to maintain work needs to be offered early, as it is difficult to get back to work if long-term absenteeism occurs. In 2013, people with RA had 5.6 more days away per year from work due to sickness absenteeism than people without RA in Denmark. This corresponds to more than 50,000 days of sick leave per year and a productivity loss of 67.3 million DKK (9.1 million EURO). Being able to work is of great importance to the experience of identity and quality of life among people with RA. People with IA struggle to find a balance between their disease, paid work, and other aspects of everyday life. In a systematic review on job loss prevention interventions targeting people with IA, we found that strategies such as job accommodation, job coaching, physical exercise, and ergonomic, and vocational counselling may have an effect on work ability, absenteeism, and job loss. The study pointed to a need for context specific tailored vocational rehabilitation (VR). Given that VR depends on the context, and countries have different social security systems, we set out to develop and test a context-specific VR. At the Danish Hospital for Rheumatic Diseases (DHR), we developed a VR called 'WORK-ON' for people with IA who consider that they were at risk of job loss within the following two years. WORK-ON was developed based on the updated Medical Research Counsil's framework for developing and evaluating Complex Interventions. In the development of WORK-ON, relevant stakeholders including patient research partners were involved. In 2022-2023 we have tested the feasibility of WORK-ON in 19 participants. The preliminary results are positive and the participants are very satisfied with the WORK-ON intervention. Based on the results from the feasibility study, we have slightly adjusted the WORK-ON intervention and we now want to test these proof of concept findings in a randomised controlled trial (RCT). Thus, the aim of this study is to test the efficacy of the adjusted WORK-ON intervention on work ability, absenteeism, and job loss relative to standard care and evaluate cost-effectiveness.

Description of the cohort

Setting: The WORK-ON RCT will be carried out at the DHR, which is a specialised hospital for rheumatic diseases and rehabilitation owned by the Danish Rheumatism Association, which is a patient organisation. The hospital has a large outpatient department and offers inpatient rehabilitation for patients with rheumatic diseases from all five regions in Denmark. Inclusion criteria - 18 - 65 years - Diagnosed with RA, PsA or ax-SpA by a rheumatologist. - Undertakes paid work (full or part-time work or studying). - Answers "unlikely" or "not certain" to question #6 from the Work Ability Questionnaire (WAI): "Do you believe, according to your present state of health, that you will be able to do your current job two years from now?" - Willing to participate in an RCT of the modified WORK-ON VR. Exclusion criteria - Planned adjustment or change in pharmacological anti-rheumatic treatment. - Morbidities other than IA that may explain reduced work ability. - Under examination for comorbidities influencing their work ability. - Had major surgery within the past six months or if future surgery is planned - Unable to understand or speak Danish at a sufficient level to participate. - Cognitive or psychological impairments that may affect participation. - Involved in another rehabilitation program (apart from physiotherapy). - Have s participated in the WORK-ON feasibility study. - An ongoing retirement application process or do not plan a to become retirement retired within the next five years. - On long-term sick leave (> 4 weeks).

Data and biological material

Socio-demographic and disease related information are collected at baseline (Age, sex, height (cm), weight (kg), living status, diagnosis, disease duration, work level, educational level, support schemes and comorbidities). The primary outcome, work ability, measured by the Work Ability Index (WAI) single item, is measured at baseline, and 6 and 12 months after baseline by questionnaire, and 18 and 30 months after baseline by phone. Key secondary outcomes are likewise measured at baseline, 6, 12, 18 and 30 months after baseline and encompass the Work Productivity and Impairment questionnaire: General Health (WPAI:GH), WAI question 2 ("How do you rate your current work ability with respect to the physical demands of your work?" and "How do you rate your current work ability with respect to the mental demands of your work?") and WAI question 6 ("Do you believe, according to your present state of health, that you will be able to do your current job two years from now?") and work hours per week. Number of days of sickness absence is collected by text-messages every month through the six month WORK-ON intervention period. Job loss is measured at 6, 12, 18 and 30 months after baseline. Secondary outcomes may be explanatory variables and encompasses Occupational Balance Questionnaire (OBQ), health-related quality of life (EQ-5D-5L), fatigue measured by the British Rheumatoid Arthritis Fatigue questionnaire (BRAF) numerical rating scales for fatigue severity, impact and coping, the WHO-5 well-being index, questions about physical activity and sleep from a Danish National Health Profile, pain measured by a visual analogue scale.

Collaborating researchers and departments

Danish Hospital for Rheumatic Diseases, Sønderborg

• Proffesor, Jette Primdahl

Publications associated with the project

Madsen CMT, Bisgaard SK, Primdahl J, Christensen JR, von Bülow C. A Systematic Review of Job Loss Prevention Interventions for Persons with Inflammatory Arthritis. J Occup Rehabil. 2021;31(4):866-85.

Madsen CMT, Primdahl J, Bremander A, Eggen L, Christensen JR. Developing a complex vocational rehabilitation intervention for patients with inflammatory arthritis: the WORK-ON study. BMC Health Serv Res. 2023;23(1):739.