- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04543097
Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care (WAVE)
Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gwenllian Wynne-Jones, PhD
- Phone Number: 01782 733962
- Email: g.wynne-jones@keele.ac.uk
Study Contact Backup
- Name: Angela Clifford, PhD
- Phone Number: 01782 731549
- Email: a.clifford@keele.ac.uk
Study Locations
-
-
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Newcastle Under Lyme, United Kingdom
- Keele University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years and over
- currently in paid employment (full or part time)
- current absence from work of at least two consecutive calendar weeks but not more than six continuous months
- received a fit note
- access to a mobile phone that can receive and respond to SMS text messages
- able to read and write English
- able to give full informed consent
- willing to participate.
Exclusion Criteria:
- Long-term work absence defined as over six continuous months
- pregnancy or on maternity leave
- patients presenting with signs or symptoms indicative of serious illness requiring urgent medical attention ('red' flags)
- severe mental health problems (e.g. severe depression with risk of self-harm, exacerbation of schizophrenia or bipolar disorder, cognitive impairment or lack of capacity)
- high vulnerability (e.g. palliative stages of illness, recent bereavement, dementia).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
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|
Experimental: 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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days absent from work
Time Frame: 6 months
|
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to work
Time Frame: 6 months or until sustained return to work (return to any work for 4 consecutive weeks)
|
RTW - Self reported number of days until return to work over 6 months, or until a sustained return to work is achieved (defined as return to any work for 4 consecutive weeks).
|
6 months or until sustained return to work (return to any work for 4 consecutive weeks)
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Work interference
Time Frame: 6 months
|
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.
Scores are multiplied by 100 to express percentages with higher numbers indicating greater impairment and less productivity i.e. worse outcomes.
|
6 months
|
Work performance
Time Frame: 6 months
|
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.
The scores will be reported as a percentage perceived loss in productivity.
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6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gwenllian Wynne-Jones, PhD, Keele University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG-0283-19
- HTA 17/94/49 (Other Grant/Funding Number: NIHR Health Technology Grant)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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