WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis

Rheumatoid Arthritis Clinical Trial

— WORK-ON  

Official title:

WORK-ON - Vocational Rehabilitation for People With Chronic Inflammatory Arthritis - a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299917
• Other study ID #: CeViG
• Secondary ID: S-20232000 - 3
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: The Danish Center for Expertise in Rheumatology
• Contact: Christina M T Madsen, MSc
• Phone: +4540297154
• Email: cmadsen[@]danskgigthospital.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 and/or problems with participation in everyday activities, including paid work.

Up to 40% lose their job in the first years after being diagnosed. 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 from work due to sickness absenteeism than people without RA in Denmark. This corresponds to more than 50,000 days of sickness absenteeism per year and a productivity loss of 67.3 million DKK (app. 9 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 interventions to prevent job loss among people with IA, showed that strategies such as job accommodation, job coaching, physical exercise, and ergonomic and vocational counselling may have an effect on job loss, work ability and absenteeism. The study pointed to a need for a context specific tailored vocational rehabilitation (VR). Given that VR depends on the context, and countries have different social security systems, it is important to develop and test a context-specific VR.

At the Danish Hospital for Rheumatic Diseases (DHR), a VR called 'WORK-ON' for people with IA who consider they are at risk of job loss within the following two years 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 addition, a logic model to help explain the associations between resources and outcomes of the intervention was developed.

In 2022-2023 the feasibility of the WORK-ON VR was tested in 19 participants. Based on the results from the feasibility test, the WORK-ON VR was slightly adjusted based on qualitative evaluations with patients and rehabilitation clinicians.

Work ability is considered to be a proxy for future job loss.

Aim: To test the efficacy of the adjusted WORK-ON VR on work ability relative to usual care.

Material and Methods: This study was developed in accordance with the Usual Protocol Items:

Recommendations for Interventional Trials (SPIRIT) reporting guideline. The trial is planned as a randomised controlled trial (RCT) with a two group parallel design. Participants will be allocated 1:1 to either the WORK-ON VR (the intervention group) or usual care (the control group) stratified by diagnosis and disease duration.

The trial is based on a two-sided superiority framework where the primary null hypothesis is that there is no difference between the groups (H0: µ[I] = µ[C]) on change in the primary outcome.

Study setting: The WORK-ON VR will be carried out at the DHR, which is a specialised hospital for rheumatic diseases and rehabilitation owned by the patient organisation, the Danish Rheumatism Association. The hospital has a large outpatient department and offers inpatient rehabilitation for patients with rheumatic diseases from all five regions in Denmark.

Recruitment: Before each outpatient consultation at the DHR, all patients with IA complete questionnaires collected in the national rheumatology quality database, DANBIO at a touchscreen in the waiting area or at a mobile phone, tablet or computer at home. An initial screening will be performed in DANBIO. For patients with a diagnosis of RA, axSpA or PsA and 18 ≤ age ≤65, the regular questionnaires at the present visit are followed by a question whether the patient is in paid work or not. If yes, question #6 from the WAI questionnaire follows: "Do you believe, according to your present state of health, that you will be able to do your current job two years from now?". If the patient answers "unlikely" or "not certain", a short information about WORK-ON is shown as a pop-up text at the screen. If the patient is interested to hear more about the WORK-ON VR, they are prompted to insert their phone number. Interested patients are contacted by a project member by phone to offer more information about the study within the following week. If still interested, a project member will check the remaining in- and exclusion criteria in the patient's medical journal. If the patient fulfils all eligibility criteria, written participant information is sent by e-mail to allow interested patients time for consideration before they are asked to give their written consent. If the patient wants to participate, a written consent is collected through REDCap

Randomisation and blinding: Randomisation and data collection will be performed using the Research Electronic Data Capture (REDCap) hosted by the Open Patient data Explorative Network (OPEN). OPEN is a safe storage and analysis environment in the Region of Southern Denmark. REDCap is a secure web application to be used for randomisation and for building and managing online surveys. Randomisation will be performed using block randomisation and is stratified by diagnosis. Due to the nature of the intervention, neither the rehabilitation clinicians nor the participants can be blinded. The statistical analyses will be performed blinded to group allocation.

Ethics: The participants will be informed verbally and in writing about the study before providing their written consent to participate before the first consultation. The study will be conducted in accordance with the Helsinki Declaration. The leaflet," Research subjects' rights in health science research" published by the Danish National Committee on Health Research Ethics, is provided to all participants. The Regional Committees on Health Research Ethics waived the need for a formal approval (Journal number S-20232000-3). Data will be stored and managed in OPEN, which adheres to the European General Data Protection Regulations and the Danish data protection law.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• =18 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 a trial of the modified WORK-ON intervention.

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).

• An ongoing retirement application process or do not plan a retirement within the next three years.

• On long-term sick leave (> 4 weeks).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Axial Spondyloarthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Hospital for Rheumatic Diseases	Sønderborg

Sponsors (5)

Lead Sponsor	Collaborator
The Danish Center for Expertise in Rheumatology	Danish Association of Occupational Therapist, Odense Patient Data Explorative Network, Schaufuss foundation, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Job loss	Number of participants who currently has a job	6,12,18 and 30 months after baseline
Secondary	Work hours per week	Number of work hours per week	Baseline, 6,12,18 and 30 months after baseline
Secondary	Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH)	Measures Absenteeism, Presenteeism, Overall work impairment and Activity impairment.	Baseline, 6,12,18 and 30 months after baseline
Secondary	Sickness absenteeism	Days and hours of sick leave	Each month after baseline during the 6 month intervention period via text message reminders.
Secondary	Work ability in relation to demands	Work Ability Index (WAI), question 2 Includes two questions about current work ability in relation to physical and mental demands.	Baseline, 6,12,18 and 30 months after baseline
Secondary	Job insecurity	Work ability Index (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?"	Baseline, 6,12,18 and 30 months after baseline
Secondary	Physical activity while at work	Standing or walking with lifting or carrying Physically demanding job Mostly stationary work Mostly standing or walking	Baseline, 6 and 12 months after baseline
Secondary	Occupational balance	Occupational Balance Questionnaire (OBQ-11) that measures measures the participant's experience of balance in the amount and variation of their everyday activities.	Baseline, 6 and 12 months after baseline
Secondary	Health related quality of life	EuroQol-5 Dimensions, 5 levels (EQ-5D-5L) is a generic measure to assess population health. Includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) -1 to 1, worst to best.	Baseline, 6 and 12 months after baseline
Secondary	VAS Pain	Visual analogue scale (VAS) pain, measuring self-rated pain at the moment from 0-10 One question encompassing pain experienced over the previous four weeks and to what extent physical pain affected work and household chores	Baseline, 6 and 12 months after baseline
Secondary	Fatigue	Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales version 2 (BRAF-NRSv2) is three separate numerical rating scales (scored from 0-10, higher is better), which cover three items: fatigue level (severity), effect on life (impact), and coping	Baseline, 6 and 12 months after baseline
Secondary	Physical activity	Over the previous year, how would you describe your physical activity? How many days a week are you physically active for at least 30 minutes?	Baseline, 6 and 12 months after baseline
Secondary	Mental well-being	WHO-5 Well-being Index, The 5-item Well-Being Index is a generic rating scale measuring subjective well-being.	Baseline, 6 and 12 months after baseline
Secondary	Sleep	Number of hours and minutes of sleep during a normal night the previous 4 weeks During the previous 4 weeks, did you get enough sleep to feel rested?; Questions about how you sleep: Did you have trouble falling asleep? Did you wake up several times at night and have difficulty falling asleep? Did you wake up early and were unable to fall asleep again? Did you sleep restlessly?	Baseline, 6 and 12 months after baseline
Secondary	Work Ability Index (WAI) single item	A visual analogue scale that compares perceived work ability with lifetime best score (0-10) The score ranges from 0 (completely unable to work) to 10 (work ability at its best)	12, 18 and 30 months after baseline