Bakker N F, van Weely S F E, Hutting N, Heerkens Y F, Engels J A, Staal J B, van der Leeden M, Boonen A, van den Hout W B, Vliet Vlieland T P M, Knoop J
Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Albinusdreef 2, P.O.Box 9600, 2300 RC, Leiden, the Netherlands.
Research Group Occupation & Health, HAN University of Applied Sciences, Nijmegen, the Netherlands.
BMC Rheumatol. 2023 Sep 20;7(1):31. doi: 10.1186/s41927-023-00357-4.
Although reduced work ability is a substantial problem among people with inflammatory arthritis (IA), work ability is an underexposed area in clinical practice. Evidence on vocational interventions in IA is limited, but favourable results of delivery by a physiotherapist (PT) warrant the need for further research. Therefore, we aim to evaluate the (cost-)effectiveness of a multimodal, PT-led, vocational intervention in (self-)employed people with IA compared to usual care.
This randomized controlled trial will include 140 people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who are (self-)employed and have reduced work ability (Work Ability Index - Single Item Scale (WAS) ≤ 7/10) and/or RA/axSpA related sick leave (≤ 6 months). Participants will be randomized 1:1 to the intervention or control condition (usual care). The intervention, delivered by primary care PTs, will be personalized to each patient, consisting of 10 to 21 sessions over 12 months. The intervention will be multimodal, comprising of 1) exercise therapy and a physical activity plan, 2) education/self-management support, 3) work-roadmap to guide participants in finding relevant other care, with optionally 4) online self-management course and 5) workplace examination. Assessments will be performed at baseline and after 3, 6, and 12 months. The primary outcome measure of effectiveness is work ability, as measured with the WAS at 12 months. For the cost-effectiveness analysis, the EuroQol (EQ-5D-5L), self-reported healthcare use, sick leave and productivity while at work will be used to estimate the trial based cost-utility from a societal perspective. A process evaluation, including assessments of adherence and treatment fidelity, will be undertaken using the registrations of the PTs and semi-structured interviews at 12 months follow-up in a random sample of the intervention group.
The results of this study will provide insights in the (cost-)effectiveness of a multimodal, PT-led, vocational intervention in people with IA and a reduced work ability.
This study is registered in the International Clinical Trial Registry Platform (ICTRP) under number NL9343.
尽管工作能力下降在炎性关节炎（IA）患者中是一个重大问题，但工作能力在临床实践中是一个未得到充分关注的领域。关于IA职业干预的证据有限，但物理治疗师（PT）提供的干预取得了良好效果，这表明有必要进行进一步研究。因此，我们旨在评估与常规护理相比，由PT主导的多模式职业干预对（个体）从业IA患者的（成本）效益。
这项随机对照试验将纳入140名患有类风湿关节炎（RA）或中轴型脊柱关节炎（axSpA）的（个体）从业者，他们工作能力下降（工作能力指数 - 单项量表（WAS）≤7/10）和/或有RA/axSpA相关病假（≤6个月）。参与者将按1:1随机分配至干预组或对照组（常规护理）。由初级保健PT提供的干预将针对每位患者进行个性化定制，包括在12个月内进行10至21次治疗。干预将是多模式的，包括1）运动疗法和身体活动计划，2）教育/自我管理支持，3）工作路线图以指导参与者寻求其他相关护理，还可选择4）在线自我管理课程和5）工作场所检查。将在基线以及3、6和12个月后进行评估。有效性的主要结局指标是工作能力，通过12个月时的WAS进行测量。对于成本效益分析，将使用欧洲五维度健康量表（EQ - 5D - 5L）、自我报告的医疗保健使用情况、病假和工作时的生产力，从社会角度估计试验的成本效用。将通过PT的记录以及在干预组随机样本中进行的12个月随访时的半结构化访谈，开展包括依从性和治疗保真度评估在内的过程评估。
本研究结果将为对工作能力下降的IA患者进行由PT主导的多模式职业干预的（成本）效益提供见解。
本研究已在国际临床试验注册平台（ICTRP）注册，注册号为NL9343。
