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| ID | Type | Description | Link |
|---|---|---|---|
| HTA 17/94/49 | Other Grant/Funding Number | NIHR Health Technology Grant |
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| Name | Class |
|---|---|
| University of Southampton | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| University of Birmingham | OTHER |
| Aston University |
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Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain.
The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective?
WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis.
Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs).
The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work.
Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice. | |
| Usual care plus vocational support | Experimental | Vocational support following a stepped care model based on the principles of case management in addition to usual primary care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocational Support | Behavioral | Participants randomised to receive vocational advice will all be offered: Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) to identify obstacles to Return to Work (RTW) and support RTW planning. Step 2, face-to-face (in person or by videoconference) in-depth discussion of obstacles to RTW and further support for RTW planning. Step 3, contact by the VSW (with participant consent) with the participants' workplace. The frequency of contact will be individualised to the needs of participants and the offer of support continued until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Absent From Work | Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Work Interference | Work Productivity Activity Impairment (WPAI) Questionnaire to measure impairments to work and activities in the past seven days. The WPAI provides four sets of scores; absenteeism, presenteeism, work productivity loss and activity impairment. It calculates four main scores calculated and expressed as percentages ranging from 0% to 100%. A higher percentage means a greater reduction in productivity and a higher level of impairment due to a health problem:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwenllian Wynne-Jones, PhD | Keele University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keele University | Newcastle-under-Lyme | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41469060 | Derived | Wynne-Jones G, Sowden G, Madan I, Walker-Bone K, Chew-Graham C, Saunders B, Lewis M, Bromley K, Jowett S, Parsons V, Mansell G, Cooke K, Lawton SA, Linaker C, Pemberton J, Cooper C, Foster NE. Can vocational advice be delivered in primary care? The Work And Vocational advicE (WAVE) mixed method single arm feasibility study. BMJ Open. 2025 Dec 29;15(12):e098768. doi: 10.1136/bmjopen-2025-098768. |
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Any requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University's data sharing procedure.
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Patients were recruited from GP practices in three regions of England
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice. |
| FG001 | Usual Care Plus Vocational Support |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2024 | Jul 28, 2025 |
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| OTHER |
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Participants, their treating clinicians and VSWs cannot be blinded to allocation due to the nature of the intervention. The data will be analysed independently by two statisticians one of whom will be blinded to intervention allocation the other statistician will be unblinded to allow intervention delivery details to be reported to the Trial Steering Committee (TSC) / Data Monitoring Committee (DMC) if required.
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| 6 months |
| Work Performance | Single Item Productivity Questionnaire (SIPQ) measured using a Visual Analogue Scale with scores ranging from 0 (health has not impacted on work performance at all) to 10 (health is so bad participant has been unable to do their job) a higher score indicates a worse outcome. | 6 months |
| Return to Work Self-efficacy (RTW-SE) | Return to work self-efficacy evaluates an employee's confidence in their ability to successfully resume their job while managing a health condition. This is indicated with scores ranging from 1 (not at all confident) to 10 (totally confident), a lower score indicates poorer confidence. | 6 months |
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice. |
| BG001 | Usual Care Plus Vocational Support | Vocational support following a stepped care model based on the principles of case management in addition to usual primary care. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days Absent From Work | Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation). | Data are reported at the 6-month timepoint, there is some loss to follow-up. | Posted | Mean | Standard Deviation | Days absence | 6 months |
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| Secondary | Work Interference | Work Productivity Activity Impairment (WPAI) Questionnaire to measure impairments to work and activities in the past seven days. The WPAI provides four sets of scores; absenteeism, presenteeism, work productivity loss and activity impairment. It calculates four main scores calculated and expressed as percentages ranging from 0% to 100%. A higher percentage means a greater reduction in productivity and a higher level of impairment due to a health problem:
| Data are reported at the 6-month timepoint, there is some loss to follow-up. | Posted | Mean | Standard Deviation | Scores on a scale (0-100%) | 6 months |
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| Secondary | Work Performance | Single Item Productivity Questionnaire (SIPQ) measured using a Visual Analogue Scale with scores ranging from 0 (health has not impacted on work performance at all) to 10 (health is so bad participant has been unable to do their job) a higher score indicates a worse outcome. | Data are reported at the 6-month timepoint, there is some loss to follow-up. | Posted | Mean | Standard Deviation | Scores on a scale (0-10) | 6 months |
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| Secondary | Return to Work Self-efficacy (RTW-SE) | Return to work self-efficacy evaluates an employee's confidence in their ability to successfully resume their job while managing a health condition. This is indicated with scores ranging from 1 (not at all confident) to 10 (totally confident), a lower score indicates poorer confidence. | Posted | Mean | Standard Deviation | Scores on a scale (1-10) | 6 months |
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From enrolment to the end of follow-up at 6-months.
Anyone involved in the WAVE trial (including Vocational Support Workers, GPs and Trial Managers) were asked to record events or concerns about the safety of participants that arose as a result of the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice. | 0 | 64 | 0 | 64 | 0 | 64 |
| EG001 | Usual Care Plus Vocational Support | Vocational support following a stepped care model based on the principles of case management in addition to usual primary care. | 0 | 66 | 0 | 66 | 0 | 66 |
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The WAVE trial was significantly affected by the COVID-19 pandemic which impacted the trial timelines with recruitment to the feasibility study commencing in December 2021. Additionally the WAVE trial was set in primary care which was under pressure to reduce footfall in practices and to change ways of working to more remote healthcare delivery which impacted on the methods of recruitment. As a result the trial closed early due to recruitment challenges.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gwenllian Wynne-Jones | Keele University | 01782 732950 | ctu.operations@keele.ac.uk |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2021 | Jul 28, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D001523 | Mental Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| Male |
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| Other ethnicity |
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