WORK-ON Vocational Rehabilitation for People with Inflammatory Arthritis

Sponsor
The Danish Center for Expertise in Rheumatology
Study ID
NCT06299917
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • WORK-ON — OTHER
    The intervention includes three parts: 1) a coordinating occupational therapist, 2) four group sessions and 3) Individual consultations based on the agreed upon goals.

Study Details

People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues. Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.

Key Dates

First listed
Mar 8, 2024
Start date
Mar 1, 2024
Status verified
Oct 2024
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: WORK-ON
    The 6-months WORK-ON VR includes three parts in addition to usual care: 1: A coordinating occupational therapist (OT) (10 hours): An initial assessment and goal setting process. Support to navigate offers in the municipalities and to involve the employer. Provides individual support in relation to the goals agreed upon. After six months, goals, the patients' progress during the intervention and future need for support are evaluated. Follow-up consultation 12 months after baseline. Group sessions to meet with others in the same situation and exchange experiences. 1. Legislative offers (social worker and coordinating OT) 2. Acceptance of the disease in relation to work (nurse and the coordinating OT). 3. Coping strategies (physiotherapist and coordinating OT). 4. Follow-up (nurse and the coordinating OT). Up to 8 individual consultations are offered with a physiotherapist, nurse and or social worker to achieve the goals.
  • No Intervention: Usual care
    Both the intervention and the control group will receive usual care in the outpatient department. Usual care consists of planned outpatient consultations every 3-12 months depending on the patient's needs, alternating between a rheumatologist and rheumatology nurses. In addition, they have access to support from a telephone help-line to the rheumatology nurses. The planned consultations include review of blood tests, joint examinations, review of completed questionnaires in DANBIO, which is a national rheumatology quality database, adherence to the pharmacological treatment and evaluation of whether pharmacological adjustment is necessary. The nurses can provide limited occasional patient education tailored to the specific patient on management of their disease, medications and symptoms. The participants in the control group will be offered pamphlets for their employer and colleagues (Dear Employer and Dear colleague)

Primary Outcome Measure

Work Ability Index (WAI) single item [ Time Frame: Baseline to 6 months after baseline ]

Central Contacts

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