Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299917
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-02-23
Brief Title:
WORK-ON Vocational Rehabilitation for People with Inflammatory Arthritis
Sponsor:
The Danish Center for Expertise in Rheumatology
Organization:
The Danish Center for Expertise in Rheumatology
Study Overview
Official Title:
WORK-ON - Vocational Rehabilitation for People with Chronic Inflammatory Arthritis - a Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WORK-ON
Brief Summary:
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 Councils 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
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
Detailed Description:
In Denmark about 100000 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 andor 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 56 more days away from work due to sickness absenteeism than people without RA in Denmark This corresponds to more than 50000 days of sickness absenteeism per year and a productivity loss of 673 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 Counsils 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
Work ability is considered to be a proxy for future job loss
Aim To test the efficacy of the adjusted WORK-ON VR on work ability relative to usual care
Material and Methods This study was developed in accordance with the Usual Protocol Items Recommendations for Interventional Trials SPIRIT reporting guideline The trial is planned as a randomised controlled trial RCT with a two group parallel design Participants will be allocated 11 to either the WORK-ON VR the intervention group or usual care the control group stratified by diagnosis and disease duration
The trial is based on a two-sided superiority framework where the primary null hypothesis is that there is no difference between the groups H0 µI µC on change in the primary outcome
Study setting The WORK-ON VR will be carried out at the DHR which is a specialised hospital for rheumatic diseases and rehabilitation owned by the patient organisation the Danish Rheumatism Association The hospital has a large outpatient department and offers inpatient rehabilitation for patients with rheumatic diseases from all five regions in Denmark
Recruitment Before each outpatient consultation at the DHR all patients with IA complete questionnaires collected in the national rheumatology quality database DANBIO at a touchscreen in the waiting area or at a mobile phone tablet or computer at home An initial screening will be performed in DANBIO For patients with a diagnosis of RA axSpA or PsA and 18 age 65 the regular questionnaires at the present visit are followed by a question whether the patient is in paid work or not If yes question 6 from the WAI questionnaire follows Do you believe according to your present state of health that you will be able to do your current job two years from now If the patient answers unlikely or not certain a short information about WORK-ON is shown as a pop-up text at the screen If the patient is interested to hear more about the WORK-ON VR they are prompted to insert their phone number Interested patients are contacted by a project member by phone to offer more information about the study within the following week If still interested a project member will check the remaining in- and exclusion criteria in the patients medical journal If the patient fulfils all eligibility criteria written participant information is sent by e-mail to allow interested patients time for consideration before they are asked to give their written consent If the patient wants to participate a written consent is collected through REDCap
Randomisation and blinding Randomisation and data collection will be performed using the Research Electronic Data Capture REDCap hosted by the Open Patient data Explorative Network OPEN OPEN is a safe storage and analysis environment in the Region of Southern Denmark REDCap is a secure web application to be used for randomisation and for building and managing online surveys Randomisation will be performed using block randomisation and is stratified by diagnosis Due to the nature of the intervention neither the rehabilitation clinicians nor the participants can be blinded The statistical analyses will be performed blinded to group allocation
Ethics The participants will be informed verbally and in writing about the study before providing their written consent to participate before the first consultation The study will be conducted in accordance with the Helsinki Declaration The leaflet Research subjects rights in health science research published by the Danish National Committee on Health Research Ethics is provided to all participants The Regional Committees on Health Research Ethics waived the need for a formal approval Journal number S-20232000-3 Data will be stored and managed in OPEN which adheres to the European General Data Protection Regulations and the Danish data protection law
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 56 more days away from work due to sickness absenteeism than people without RA in Denmark This corresponds to more than 50000 days of sickness absenteeism per year and a productivity loss of 673 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 Counsils 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
Work ability is considered to be a proxy for future job loss
Aim To test the efficacy of the adjusted WORK-ON VR on work ability relative to usual care
Material and Methods This study was developed in accordance with the Usual Protocol Items Recommendations for Interventional Trials SPIRIT reporting guideline The trial is planned as a randomised controlled trial RCT with a two group parallel design Participants will be allocated 11 to either the WORK-ON VR the intervention group or usual care the control group stratified by diagnosis and disease duration
The trial is based on a two-sided superiority framework where the primary null hypothesis is that there is no difference between the groups H0 µI µC on change in the primary outcome
Study setting The WORK-ON VR will be carried out at the DHR which is a specialised hospital for rheumatic diseases and rehabilitation owned by the patient organisation the Danish Rheumatism Association The hospital has a large outpatient department and offers inpatient rehabilitation for patients with rheumatic diseases from all five regions in Denmark
Recruitment Before each outpatient consultation at the DHR all patients with IA complete questionnaires collected in the national rheumatology quality database DANBIO at a touchscreen in the waiting area or at a mobile phone tablet or computer at home An initial screening will be performed in DANBIO For patients with a diagnosis of RA axSpA or PsA and 18 age 65 the regular questionnaires at the present visit are followed by a question whether the patient is in paid work or not If yes question 6 from the WAI questionnaire follows Do you believe according to your present state of health that you will be able to do your current job two years from now If the patient answers unlikely or not certain a short information about WORK-ON is shown as a pop-up text at the screen If the patient is interested to hear more about the WORK-ON VR they are prompted to insert their phone number Interested patients are contacted by a project member by phone to offer more information about the study within the following week If still interested a project member will check the remaining in- and exclusion criteria in the patients medical journal If the patient fulfils all eligibility criteria written participant information is sent by e-mail to allow interested patients time for consideration before they are asked to give their written consent If the patient wants to participate a written consent is collected through REDCap
Randomisation and blinding Randomisation and data collection will be performed using the Research Electronic Data Capture REDCap hosted by the Open Patient data Explorative Network OPEN OPEN is a safe storage and analysis environment in the Region of Southern Denmark REDCap is a secure web application to be used for randomisation and for building and managing online surveys Randomisation will be performed using block randomisation and is stratified by diagnosis Due to the nature of the intervention neither the rehabilitation clinicians nor the participants can be blinded The statistical analyses will be performed blinded to group allocation
Ethics The participants will be informed verbally and in writing about the study before providing their written consent to participate before the first consultation The study will be conducted in accordance with the Helsinki Declaration The leaflet Research subjects rights in health science research published by the Danish National Committee on Health Research Ethics is provided to all participants The Regional Committees on Health Research Ethics waived the need for a formal approval Journal number S-20232000-3 Data will be stored and managed in OPEN which adheres to the European General Data Protection Regulations and the Danish data protection law
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S-20232000 - 3 | OTHER | Committees on Health Research Ethics for Southern Denmark | None |