Physiotherapy WORKs: a randomized controlled trial on the (cost)effectiveness of a physiotherapist-led, multi-modal, personalized, work-oriented intervention in inflammatory arthritis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26117

Enrollment

140

Registered

2021-03-17

Start date

2020-11-02

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis and Axial Spondyloarthritis

Interventions

A physiotherapist-led, multi-modal, personalized, work-oriented intervention (intervention) or usual care (control)

Eligibility

Inclusion criteria

Inclusion criteria: A patient should meet all of the following criteria to be eligible, tested by the rheumatologist (during regular visit) and/or researcher (by phone): • Diagnosed with RA or axSpA by a rheumatologist. • Having (self-)payed employment for =12 hours/week. • Moderate to poor work ability (Work Ability Index-Single Item Scale (WAS) =7/10 (13)) related to RA/axSpA and/or self-reported history of sick-leave in the past 6 months related to RA/axSpA. • Self-reported limitations in physical functioning. • Willingness to consult a participating PT located nearby. • Willingness to pay for physical therapy (out-of-pocket or by supplementary health insurance). • Command of Dutch language. • Providing informed consent.

Exclusion criteria

Exclusion criteria: A patient will be excluded if any of the following criteria are met, tested by the rheumatologist (during regular visit) and/or researcher (by phone): • Pension-eligible age within 2 years. • Comorbid disease or other (e.g. financial) situation influencing work ability. • Pregnancy. • In labour dispute. • Current sick leave period of more than 6 months.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be work ability, assessed by the Work Ability Index – Single Item Scale.	—

Secondary

Measure	Time frame
The secondary outcome measures include: i. Presenteeism, absenteeism and productivity, assessed by the RA-specific or axSpA-specific Work Productivity and Activity Impairment questionnaire (WPAI) ii. Job satisfaction iii. Self-efficacy at work iv. Pain severity in past 7 days with a Numeric Rating Scale (NRS) a. Supplementary measure only for axSpA: disease activity, assessed with Bath AS Disease Activity Index (BASDAI) v. Fatigue in past 7 days on NRS vi. Specific work-related limitations in physical functioning, assessed on the Patient Specific Complaints instrument (PSC) vii. Physical function, assessed on Patient Reported Outcomes Measurement Information System (PROMIS Short Form Physical Function) a. Supplementary measure only for axSpA: Bath Ankylosing Spondylitis Functional Index (BASFI) viii. Physical activity level, assessed on the modified Short Questionnaire to Assess Health-enhancing physical activity (m-SQUASH) ix. Anxiety and depression, assessed by the Hospital Anxiety and Depression Scale (HADS) x. Global Perceived Effect (GPE) xi. Societal costs (health care utilization, informal care and work-related costs); 10 items. xii. Quality-adjusted life years (QALYs), calculated by EQ-5D-5L; 6 items (36).	—

Measure

Time frame

The secondary outcome measures include: i. Presenteeism, absenteeism and productivity, assessed by the RA-specific or axSpA-specific Work Productivity and Activity Impairment questionnaire (WPAI) ii. Job satisfaction iii. Self-efficacy at work iv. Pain severity in past 7 days with a Numeric Rating Scale (NRS) a. Supplementary measure only for axSpA: disease activity, assessed with Bath AS Disease Activity Index (BASDAI) v. Fatigue in past 7 days on NRS vi. Specific work-related limitations in physical functioning, assessed on the Patient Specific Complaints instrument (PSC) vii. Physical function, assessed on Patient Reported Outcomes Measurement Information System (PROMIS Short Form Physical Function) a. Supplementary measure only for axSpA: Bath Ankylosing Spondylitis Functional Index (BASFI) viii. Physical activity level, assessed on the modified Short Questionnaire to Assess Health-enhancing physical activity (m-SQUASH) ix. Anxiety and depression, assessed by the Hospital Anxiety and Depression Scale (HADS) x. Global Perceived Effect (GPE) xi. Societal costs (health care utilization, informal care and work-related costs); 10 items. xii. Quality-adjusted life years (QALYs), calculated by EQ-5D-5L; 6 items (36).

—

Contacts

Public ContactThea Vliet Vlieland

LUMC, Leiden

FTWERKt@lumc.nl071-5263616

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)