Background
Feasibility study
Choice of comparators
Objectives
Trial design
Methods
Study setting
Eligibility criteria
Inclusion criteria
Exclusion criteria
Interventions
Control and intervention groups: treatment regimens
Concomitant care
Criteria for discontinuing or modifying allocated interventions
Therapist training in WORKWELL JRVR
Ancillary and post-trial care
Participant timeline
Outcomes
Data collection | Measurement Method | Details | 0-Months | 6-Months | 12-Months |
---|---|---|---|---|---|
Contextual factors: personal (demographic; disease status) | |||||
Age | Date of birth | ✓ | |||
Gender | ✓ | ||||
Ethnic group | ✓ | ||||
Marital status | ✓ | ||||
Living status | Alone; or with family/ significant others | ✓ | |||
Educational status | Highest qualification | ✓ | |||
Time since RA/ IA/ PsA symptom onset | ✓ | ||||
Time since RA/ IA/ PsA diagnosis | ✓ | ||||
Comorbidities | Rheumatic Disease Comorbidity Index [39] | Presence/absence of 11 comorbidities | ✓ | ||
Job Descriptors | a) number of hours worked/week; b) contract type/ self-employment; c) length of time in current main job (0 m only). | ✓ | ✓ | ✓ | |
Income status | Sole income earner in household | ✓ | |||
Primary Outcome measure: | |||||
Presenteeism | The Work Limitations Questionnairea (WLQ-25) [27] | 25 items: percentage time (in last 2/52) limited in: physical work demands, time demands, mental-interpersonal demands and output demands (0–4 scale of 0 to 100%). | ✓ | ✓ | ✓ |
Secondary outcome measures | |||||
Presenteeism | Work Activities Limitations Scalea (WALS) [40] | 12 items: degree of difficulty in work activities (0 = no difficulty; 3 = unable to do) | ✓ | ✓ | ✓ |
Combined WLQ-25 WALSa [41] | Combination of above two measures | ✓ | ✓ | ✓ | |
WLQ-25 [27] | 4 subscales calculated from relevant items in the WLQ-25 questionnaire | ✓ | ✓ | ✓ | |
Absenteeism and Presenteeism | Work Productivity and Activity Impairment Questionnaire General Health V2.0 (WPAI-GH) [42] | Last 7 days: time off on sick leave/any other reason; hours worked; health problems effect on work productivity and ability to do other daily activities. | ✓ | ✓ | ✓ |
Work status | Work Transitions Index [43] | Whether employed; in full- or part-time work | ✓ | ✓ | ✓ |
Work instability | Work instability scale (RA-WIS) [30] | 23 true/false items: degree mismatch between functional abilities and workplace demands | ✓ | ✓ | |
Work self-efficacy | 0–10-point numeric rating scales (NRS) 0 = not at all to 10 = very. 3 work self-efficacy items (confidence in working, managing health condition at work and work not making condition worse (0–10 NRS) | ✓ | ✓ | ||
Health Outcome measures | |||||
Health status | SF-12v2 Health Survey [44] | 12 items, assessed over the last four weeks, scored as physical and mental health sub-scales | ✓ | ✓ | ✓ |
Disease impact | Rheumatoid Arthritis Impact of Disease (RAID) [45] | Composite score from: 7domains of impact of RA: coping, emotional wellbeing, fatigue, physical function, sleep, global assessment and pain | ✓ | ✓ | |
Disease activity | RA Disease Activity Index-5 (RADAI-5) [46] | Self- reported disease severity in last 6 months; current joint tenderness and swelling; pain, general health; hand joint stiffness duration | ✓ | ✓ | |
Hand/ wrist pain | In the last week during moderate activity (e.g. cooking, housework): 0–10 NRS | ✓ | ✓ | ||
Exploratory outcome measures | |||||
Number of hours worked | On average, number of hours contracted to work and number of hours usually work | ✓ | ✓ | ✓ | |
Change in occupation or hours | Any change in occupation or number of hours worked with reason for change | ✓ | ✓ | ||
Work self-efficacy | Confidence, motivation and importance of continuing to work over next year, scored 0–10 | ✓ | ✓ | ||
Work advice received | Satisfaction with work advice received (0–10 NRS) and what other work advice they received from where | ✓ | |||
Economic Evaluation: Use of Resources | |||||
Health related Quality of Life | EuroQol Five Dimensions questionnaire (EQ-5D-5L) [47] | 5-items Scale (Mobility; Self-care; Usual activities; Pain/Discomfort; Anxiety/Depression; plus 0–100 scale | ✓ | ✓ | ✓ |
Use of NHS and Social Care, Local Authority and Private Health Services | Your use of hospital in-patient services | a) Any planned hospital overnight stays in the last 6 months b) If yes, department, and number nights | ✓ | ✓ | ✓ |
Your use of hospital out-patient appointments | a) Any planned hospital outpatient appointments lasting 4 h or less in the last 6 months b) If yes, department and number of appointments | ✓ | ✓ | ✓ | |
Your use of day hospital appointments | a) Any day or hospital outpatient lasting more than 4 h but not overnight during the last 6 months b) If yes, department, and number of appointments | ✓ | ✓ | ✓ | |
Your use of accident and emergency services | a) Any A&E attendance in the last 6 months b) If yes, number of visits not leading to hospital admission c) number of visits admitted into a hospital as an in-patient from A&E d) reason for admission | ✓ | ✓ | ✓ | |
Your use of primary and community-based health services; Local Authority Social Services; private health services | a) Use of primary care services / Local Authority Social Services (e.g. GP, Practice Nurse, District Nurse, Counsellor, social worker, occupational therapist) in the last 6 months b) If yes, number of visits to each | ✓ | ✓ | ✓ | |
Medication | Current medication for RA/IA/PsA; date medication started | ✓ | ✓ | ✓ | |
Workplace changes | Changes to workplace environment | Changes made by employer (e.g. specialised equipment). | ✓ | ✓ | ✓ |
Contextual factors: environmental factors | |||||
Nature of work | Job skill level 1–4 (UK Standard Occupational Classification (SOC2010)) [48]. | Main job title and industry working in | ✓ | ||
Job responsibilities | e.g. overtime, variable hours; and need to travel for business | ✓ | |||
Work demands | Two items: physical and mental work demands | ✓ | ✓ | ||
Control over work and flexibility [49] | Four items: control over work schedule, job flexibility, ability to postpone work tasks and help from colleagues with work | ✓ | ✓ | ||
Work productivity | One item: self-reported work productivity in the last 6 months | ✓ | ✓ | ✓ | |
Work Transitions | The Work Transitions Index (WTI)a [43]. | Includes a) employment status; b) 14 items assessing: job disruptions due to arthritis c) sickness absence due to arthritis or other conditions in the last 6 months; d) change in occupation or working hours in the last 6 months. | ✓ | ✓ | ✓ |
Workplace Support | The Perceived Workplace Support Scale (PWSS) [50] | a 19-item questionnaire, of perceived managerial, co-worker and organisational support (REF) | ✓ | ✓ | |
Work support services | Access to occupation health and work support services | ✓ | ✓ | ||
Work Policies and Accommodations | The Workplace Accommodations, Benefits, Policies and Practices Scale (WABPPS) | 17 items: job accommodations, policies and workplace practices available, use of and helpfulness | ✓ | ✓ | |
Organization Polices | Organization size | Numbers of employees in company | ✓ | ||
Contextual Factors: Personal | |||||
Personal appraisal | Job strain [53] | One item: stress currently experienced at work | ✓ | ✓ | |
Work motivation/ importance/self-efficacy | 3 items: motivation, importance and confidence to continue working (0–10 NRS) (0–10 NRS) | ||||
Disclosure [50] | Disclosure about condition to employer /line manager | ✓ | ✓ | ||
Job satisfaction | Satisfaction with job: 0–10 NRS | ✓ | ✓ | ||
Future job expectations | Two items: concerns about health affecting ability to work in future; and likelihood of leaving job in the next year due to arthritis | ✓ | ✓ | ||
Work-Life Balance | Work-life balance [54]. | Four items: perceived work-life balance taken from the Work, Health Life Balance Perceptions Scale | ✓ | ✓ |
Data collection
Work- related outcome measures
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WLQ-25 sub-scales: the four subscales measuring physical work demands, time demands, mental interpersonal demands and output demands from specific items in the WLQ-25 questionnaire [27].
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The Work Activities Limitations Scale (WALS): a reliable, valid measure including 12 items assessing degree of difficulty performing work activities (0 = no difficulty; 3 = unable to do [40].
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The Work Productivity and Activity Impairment Questionnaire General Health V2.0 (WPAI:GH): a reliable, valid measure of extent of absenteeism, presenteeism, and impairment in daily activities attributable to general health [42].
Health outcome measures
Health economic outcome measures
Process evaluation
Sample size
Recruitment
Assignment of intervention
Allocation and sequence generation
Concealment mechanism
Implementation
Blinding
Emergency unblinding
Data collection methods
Data management and confidentiality
Data validation
Data entry and coding
Confidentiality and data storage
Data transfer from the University of Salford to CTU
Data access
Statistical methods
Economic evaluation
Costs
Outcomes
Economic analysis
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a CEA conducted in line with the base case analysis but using the SF-12 to generate QALYs; previous work has indicated that this tool is particularly appropriate for the economic evaluation of work-based interventions
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a CEA in which the ICER represents the cost to employers for reduced presenteeism as measured by the WLQ-25
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a CEA in which the ICER represents the cost to employers for reduced presenteeism as measured by the WPAI
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a CEA in which the ICER represents the cost to employers for QALY gains and where levels of presenteeism, as measured by the WLQ-25, are translated into costs using the human capital approach