Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial

BMC Rheumatology

Study Protocol

W. B. van den Hout¹  A. Boonen²  T. P. M. Vliet Vlieland³  S. F. E. van Weely³  N. F. Bakker³  J. Knoop⁴  J. B. Staal⁵  M. van der Leeden⁶  J. A. Engels⁷  N. Hutting⁷  Y. F. Heerkens⁷ 

[1] Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands;Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, Maastricht, the Netherlands;Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands;Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, P.O.Box 9600, Albinusdreef 2, 2300 RC, Leiden, the Netherlands;Musculoskeletal Rehabilitation Research Group, HAN University of Applied Sciences, Nijmegen, the Netherlands;Musculoskeletal Rehabilitation Research Group, HAN University of Applied Sciences, Nijmegen, the Netherlands;Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Centre, Nijmegen, the Netherlands;Reade, Rehabilitation and Rheumatology, Amsterdam, the Netherlands;Amsterdam Movement Sciences, Musculoskeletal Health, Amsterdam, The Netherlands;Research Group Occupation & Health, HAN University of Applied Sciences, Nijmegen, the Netherlands;

关键词: Vocational rehabilitation;    Rheumatoid arthritis;    Axial spondyloarthritis;    Randomized controlled trial;    Physiotherapy;   

DOI  :  10.1186/s41927-023-00357-4

 received in 2023-06-13, accepted in 2023-09-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAlthough 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.MethodsThis 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.DiscussionThe 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.Trial registrationThis study is registered in the International Clinical Trial Registry Platform (ICTRP) under number NL9343.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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