ISRCTN61762297进行中（未招募）未知
A randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis: the WORKWELL trial
niversity of Salford0 个研究点目标入组 249 人开始时间: 2019年6月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 249
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32912199/ protocol (added 15/09/2020) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36352479/ protocol for the process evaluation (added 11/11/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36539794/ study adaption due to the COVID-19 pandemic (added 30/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults (i.e. aged > = 18 years). (Upper age limit: Participants can be above the normal age for receiving their state pension as long as they are still in paid employment)
- •2. Diagnosed with RA, UIA or PsA by a Rheumatology Consultant. (Undifferentiated Inflammatory Arthritis is defined as: persistent synovitis in more than one small joint of the hand, without any other known cause, but the person does not yet meet all the diagnostic criteria for RA. Participants can have co-morbidities (which may also be related to having RA, UIA or PsA, for example, osteoarthritis, fibromyalgia, heart condition, mild to moderate anxiety or depression; or are unrelated, e.g. diabetes
- •3. In paid work (full or part-time, self-employed or regular contractual work) for at least 15 hours per week
- •4. Participants may be on sick leave at the time of screening BUT this must be for less than 4 weeks duration and not planned or likely to extend for longer than 4 weeks
- •5. Able to read and understand English. This is because:
- •5.1. The control group will only receive the written work self-help information and unfortunately it is not possible to translate the published booklets into multiple languages within the resources of this trial and
- •5.2. Data is being collected by self-report questionnaires and many of the measures included are not linguistically validated/ translated and psychometrically tested in other languages. Thus, translating them into Welsh, for example, will not provide valid, reliable results
- •6. Score > = 10 on the RA-Work Instability Scale (RA-WIS), a measure of mismatch between the person’s abilities and their job demands. A score of > = 10 is indicative of medium to high risk of work instability and need for VR. This takes about 5 minutes to be completed and scored
- •7. Able to attend the participating site for WORKWELL appointments, if allocated to that group
- •8. Able to provide informed consent
排除标准
- •Current participant exclusion criteria as of 07/02/2022:
- •1. On extended sick leave (i.e. > 4 weeks). The WORKWELL intervention is designed for people currently in work. Long-term sick leave is defined as being > 4 weeks [NICE, 2009b]. For that group, there is advice available through the UK Government Fit for Work service, with support for return to work plans. Many people with RA, UIA or PsA do not take long-term sick leave, as once on an effective medication regimen, short-term absences are more common than long-term absences due to the fluctuating nature of these conditions. (Most (95%) of UK absences amongst all workers last less than 20 days
- •2. Already planning to retire due to age or to take early retirement (for any health or non-health reason) within the next 12 months (i.e. within the trial follow-up period)
- •3. Already due to stop work for any other reason (e.g. planned redundancy, fixed term contract due to end) within the next 12 months (i.e. within the trial follow-up period)
- •4. Planning to move out of area within the next 3 months and therefore would be unable to attend for WORKWELL appointments if allocated to that group (as treatment may not be completed in time). (If patients move out of area at short notice, they will continue to be in the trial as this is an intent-to-treat analysis)
- •5. Already receiving or awaiting VR services from Access to Work or a Vocational Rehabilitation company. These services conduct work assessments as part of VR provision. (Those receiving work services from other sources (e.g. occupational health or human resources in their organisation, online advice from Fit for Work) may still be recruited as VR provision can be of varied quality and this will be considered as usual care
- •6. Employed in the armed forces (as they could be stationed overseas during the trial period. The armed services also have their own Vocational Rehabilitation service
- •7. On furlough or Self-Employment Income Support (i.e., currently unable to attend work or work from home)
- •Previous participant exclusion criteria:
- •1. On extended sick leave (i.e. > 4 weeks). The WORKWELL intervention is designed for people currently in work. Long-term sick leave is defined as being > 4 weeks [NICE, 2009b]. For that group, there is advice available through the UK Government Fit for Work service, with support for return to work plans. Many people with RA, UIA or PsA do not take long-term sick leave, as once on an effective medication regimen, short-term absences are more common than long-term absences due to the fluctuating nature of these conditions. (Most (95%) of UK absences amongst all workers last less than 20 days
- •2. Already planning to retire due to age or to take early retirement (for any health or non-health reason) within the next 12 months (i.e. within the trial follow-up period)
- •3. Already due to stop work for any other reason (e.g. planned redundancy, fixed term contract due to end) within the next 12 months (i.e. within the trial follow-up period)
- •4. Planning to move out of area within the next 3 months and therefore would be unable to attend for WORKWELL appointments if allocated to that group (as treatment may not be completed in time). (If patients move out of area at short notice, they will continue to be in the trial as this is an intent-to-treat analysis)
- •5. Already receiving or awaiting VR services from Access to Work or a Vocational Rehabilitation company. These services conduct work assessments as part of V
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