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Completed

NCT Number: NCT04543097

Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care

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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Key information

Conditions

Musculoskeletal Pain Absence Behavior Mental Disorders Mental Health Disorder Mental Health Issue Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Other Physical Health Condition Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keele University

Newcastle-under-Lyme, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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. 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:

    • Absenteeism ([hours missed due to health, divided by total hours should have worked] multiplied by 100)
    • Presenteeism (how much health affected productivity 0 to 10, multiplied by 10)
    • Overall Work Impairment (total hours missed, plus [remaining hours worked multiplied by the presenteeism score])
    • Activity Impairment (score for how much health affected regular activities 0 to 10, multiplied by 10).

  2. 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.

  3. Return to Work Self-efficacy (RTW-SE)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Keele University

Other

Collaborators

  • Aston University
  • Guy's and St Thomas' NHS Foundation Trust
  • University of Birmingham
  • University of Southampton

Registry information

Official study title

Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial

Acronym: WAVE

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Sep 9, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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