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

Abstract Background 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) war...

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Main Authors: N. F. Bakker, S. F. E. van Weely, N. Hutting, Y. F. Heerkens, J. A. Engels, J. B. Staal, M. van der Leeden, A. Boonen, W. B. van den Hout, T. P. M. Vliet Vlieland, J. Knoop
Format: Article
Language:English
Published: BMC 2023-09-01
Series:BMC Rheumatology
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Online Access:https://doi.org/10.1186/s41927-023-00357-4
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author N. F. Bakker
S. F. E. van Weely
N. Hutting
Y. F. Heerkens
J. A. Engels
J. B. Staal
M. van der Leeden
A. Boonen
W. B. van den Hout
T. P. M. Vliet Vlieland
J. Knoop
author_facet N. F. Bakker
S. F. E. van Weely
N. Hutting
Y. F. Heerkens
J. A. Engels
J. B. Staal
M. van der Leeden
A. Boonen
W. B. van den Hout
T. P. M. Vliet Vlieland
J. Knoop
author_sort N. F. Bakker
collection DOAJ
description Abstract Background 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. Methods 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. Discussion 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. Trial registration This study is registered in the International Clinical Trial Registry Platform (ICTRP) under number NL9343.
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spelling doaj.art-d8bbbea4a4874047ad062c67439691e22023-11-26T14:32:24ZengBMCBMC Rheumatology2520-10262023-09-017111310.1186/s41927-023-00357-4Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trialN. F. Bakker0S. F. E. van Weely1N. Hutting2Y. F. Heerkens3J. A. Engels4J. B. Staal5M. van der Leeden6A. Boonen7W. B. van den Hout8T. P. M. Vliet Vlieland9J. Knoop10Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical CenterDepartment of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical CenterResearch Group Occupation & Health, HAN University of Applied SciencesResearch Group Occupation & Health, HAN University of Applied SciencesResearch Group Occupation & Health, HAN University of Applied SciencesMusculoskeletal Rehabilitation Research Group, HAN University of Applied SciencesReade, Rehabilitation and RheumatologyDepartment of Internal Medicine, Division of Rheumatology, Maastricht University Medical CentreDepartment of Biomedical Data Sciences, Leiden University Medical CenterDepartment of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical CenterMusculoskeletal Rehabilitation Research Group, HAN University of Applied SciencesAbstract Background 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. Methods 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. Discussion 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. Trial registration This study is registered in the International Clinical Trial Registry Platform (ICTRP) under number NL9343.https://doi.org/10.1186/s41927-023-00357-4Vocational rehabilitationRheumatoid arthritisAxial spondyloarthritisRandomized controlled trialPhysiotherapy
spellingShingle N. F. Bakker
S. F. E. van Weely
N. Hutting
Y. F. Heerkens
J. A. Engels
J. B. Staal
M. van der Leeden
A. Boonen
W. B. van den Hout
T. P. M. Vliet Vlieland
J. Knoop
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
Vocational rehabilitation
Rheumatoid arthritis
Axial spondyloarthritis
Randomized controlled trial
Physiotherapy
title Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial
title_full Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial
title_fullStr Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial
title_full_unstemmed Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial
title_short Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial
title_sort effectiveness and cost effectiveness of a multimodal physiotherapist led vocational intervention in people with inflammatory arthritis study protocol of the physiotherapy works trial
topic Vocational rehabilitation
Rheumatoid arthritis
Axial spondyloarthritis
Randomized controlled trial
Physiotherapy
url https://doi.org/10.1186/s41927-023-00357-4
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