WORK-ON - Vocational Rehabilitation for People With Chronic Inflammatory Arthritis - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Work Ability Index (WAI) single item
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Statistical analyses will be blinded for group allocation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
- Legislative offers (social worker and coordinating OT)
- Acceptance of the disease in relation to work (nurse and the coordinating OT).
- Coping strategies (physiotherapist and coordinating OT).
- 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.
干预措施: WORK-ON (Other)
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)
结局指标
主要结局
Work Ability Index (WAI) single item
时间窗: Baseline to 6 months after baseline
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)
次要结局
- Sickness absenteeism(Each month after baseline during the 6 month intervention period via text message reminders.)
- Work hours per week(Baseline, 6,12,18 and 30 months after baseline)
- Job insecurity(Baseline, 6,12,18 and 30 months after baseline)
- Mental well-being(Baseline, 6 and 12 months after baseline)
- Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH)(Baseline, 6,12,18 and 30 months after baseline)
- Sleep(Baseline, 6 and 12 months after baseline)
- Job loss(6,12,18 and 30 months after baseline)
- Work ability in relation to demands(Baseline, 6,12,18 and 30 months after baseline)
- Health related quality of life(Baseline, 6 and 12 months after baseline)
- Occupational balance(Baseline, 6 and 12 months after baseline)
- Fatigue(Baseline, 6 and 12 months after baseline)
- Physical activity while at work(Baseline, 6 and 12 months after baseline)
- VAS Pain(Baseline, 6 and 12 months after baseline)
- Physical activity(Baseline, 6 and 12 months after baseline)
- Work Ability Index (WAI) single item(12, 18 and 30 months after baseline)
研究者
Jette Primdahl
Professor in rheumatology rehabilitation
University of Southern Denmark