NCT04543097

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

August 12, 2020

Last Update Submit

May 8, 2025

Conditions

Musculoskeletal PainMental Health IssueMental Health DisorderOther Physical Health ConditionAbsence

Keywords

Work absenceOther health conditionsReturn to workMusculoskeletal painMental health

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Return to work

    6 months or until sustained return to work (return to any work for 4 consecutive weeks)

  • Work interference

    6 months

  • Work performance

    6 months

Study Arms (2)

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.

Behavioral: Vocational Support

Interventions

Vocational SupportBEHAVIORAL

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.

Usual care plus vocational support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keele University

Newcastle-under-Lyme, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 41469060DERIVED

Related Links

MeSH Terms

Conditions

Musculoskeletal PainMental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Gwenllian Wynne-Jones, PhD

    Keele University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

September 9, 2020

Study Start

December 23, 2020

Primary Completion

April 20, 2023

Study Completion

January 31, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Locations

GB(1)