WORK-ON Vocational Rehabilitation for People with Inflammatory Arthritis

NCT06299917 | Recruiting

• 2 other identifiers: CeViGS-20232000 - 3
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Work Ability Index (WAI) single item

  A visual analogue scale that compares perceived work ability with lifetime best score. The score ranges from 0 (completely unable to work) to 10 (work ability at its best)

  Baseline to 6 months after baseline

Secondary Outcomes (15)

• Job loss

  6,12,18 and 30 months after baseline

• Work hours per week

  Baseline, 6,12,18 and 30 months after baseline

• Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH)

  Baseline, 6,12,18 and 30 months after baseline

• Sickness absenteeism

  Each month after baseline during the 6 month intervention period via text message reminders.

• Work ability in relation to demands

  Baseline, 6,12,18 and 30 months after baseline

Study Arms (2)

WORK-ON

EXPERIMENTAL

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.

Other: WORK-ON

Usual care

NO INTERVENTION

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)

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.

WORK-ON

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years.
• Diagnosed with RA, PsA or axSpA by a rheumatologist.
• Undertakes paid work (full- or part-time work or studying).
• Able to read and understand Danish.
• Answers 'unlikely' or 'not certain' to question #6 from the WAI questionnaire: 'Do you believe, according to your present state of health, that you will be able to do your current job two years from now?' (36).
• Willing to participate in an RCT of the modified WORK-ON VR.

You may not qualify if:

• Planned or present adjustments of the pharmacological anti-rheumatic treatment (DMARDs, glucocorticoid) within the last three months.
• Presence of morbidities other than IA that may explain reduced work ability.
• Is under examination for comorbidities that influence work ability.
• Major surgery was conducted within the past six months, or a surgery has been planned.
• Is unable to understand or speak Danish at a sufficient level to participate.
• Has cognitive or psychological impairments that may affect participation.
• Planned or ongoing participation in another rehabilitation program (apart from physiotherapy).
• Has participated in the WORK-ON feasibility study.
• Retirement application process is ongoing or plans to retire within the next five years.
• Has taken long-term sick leave (\>4 weeks).

Sponsors & Collaborators

• The Danish Center for Expertise in Rheumatology: lead
• Odense Patient Data Explorative Network: collaborator
• The Danish Rheumatism Association: collaborator
• Danish Association of Occupational Therapist: collaborator
• Schaufuss foundation: collaborator

Study Sites (1)

Danish Hospital for Rheumatic Diseases

Sønderborg, 6400, Denmark

RECRUITING

Related Publications (1)

• Madsen CMT, Primdahl J, Christensen JR. Testing the efficacy of WORK-ON: vocational rehabilitation for people with chronic inflammatory arthritis in Denmark-protocol for a randomised controlled trial. BMJ Open. 2024 Nov 27;14(11):e089050. doi: 10.1136/bmjopen-2024-089050.

  PMID: 39609020 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Arthritis; 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; Ankylosis

Central Study Contacts

Christina M T Madsen, MSc

CONTACT

+4540297154; cmadsen@danskgigthospital.dk

Jette Primdahl, PhD

CONTACT

jprimdahl@danskgigthospital.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analyses will be blinded for group allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in rheumatology rehabilitation

Model Details: Single center parallel randomized study

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)