Trial Outcomes & Findings for Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care (NCT NCT04543097)
NCT ID: NCT04543097
Last Updated: 2026-07-30
Results Overview
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
TERMINATED
NA
130 participants
6 months
2026-07-30
Participant Flow
Patients were recruited from GP practices in three regions of England
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
|
Overall Study
COMPLETED
|
49
|
45
|
|
Overall Study
NOT COMPLETED
|
15
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care
Baseline characteristics by cohort
| Measure |
Usual Care
n=64 Participants
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
n=66 Participants
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.62 Years
STANDARD_DEVIATION 11.41 • n=20 Participants
|
49.30 Years
STANDARD_DEVIATION 11.31 • n=20 Participants
|
48.97 Years
STANDARD_DEVIATION 11.32 • n=40 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=20 Participants
|
47 Participants
n=20 Participants
|
90 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=20 Participants
|
51 Participants
n=20 Participants
|
97 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other ethnicity
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Missing or not stated
|
14 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data are reported at the 6-month timepoint, there is some loss to follow-up.
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
Outcome measures
| Measure |
Usual Care
n=64 Participants
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
n=66 Participants
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care.
|
|---|---|---|
|
Number of Days Absent From Work
|
42.66 Days absence
Standard Deviation 57.67
|
37.86 Days absence
Standard Deviation 48.76
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data are reported at the 6-month timepoint, there is some loss to follow-up.
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: 1. Absenteeism (\[hours missed due to health, divided by total hours should have worked\] multiplied by 100) 2. Presenteeism (how much health affected productivity 0 to 10, multiplied by 10) 3. Overall Work Impairment (total hours missed, plus \[remaining hours worked multiplied by the presenteeism score\]) 4. Activity Impairment (score for how much health affected regular activities 0 to 10, multiplied by 10).
Outcome measures
| Measure |
Usual Care
n=39 Participants
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
n=42 Participants
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care.
|
|---|---|---|
|
Work Interference
a) Absenteeism (work hours missed)
|
19.37 Scores on a scale (0-100%)
Standard Deviation 39.43
|
28.45 Scores on a scale (0-100%)
Standard Deviation 43.69
|
|
Work Interference
b) Presenteeism (reduced productivity at work)
|
34.85 Scores on a scale (0-100%)
Standard Deviation 34.38
|
33.33 Scores on a scale (0-100%)
Standard Deviation 31.44
|
|
Work Interference
c) Work productivity loss (combined absenteeism & presenteeism)
|
40.56 Scores on a scale (0-100%)
Standard Deviation 34.55
|
35.86 Scores on a scale (0-100%)
Standard Deviation 31.71
|
|
Work Interference
d) Activity impairment (affected unpaid daily activities)
|
38.21 Scores on a scale (0-100%)
Standard Deviation 32.51
|
42.00 Scores on a scale (0-100%)
Standard Deviation 37.84
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data are reported at the 6-month timepoint, there is some loss to follow-up.
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.
Outcome measures
| Measure |
Usual Care
n=39 Participants
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
n=42 Participants
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care.
|
|---|---|---|
|
Work Performance
|
4.90 Scores on a scale (0-10)
Standard Deviation 3.67
|
4.30 Scores on a scale (0-10)
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: 6 monthsReturn 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.
Outcome measures
| Measure |
Usual Care
n=39 Participants
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
n=42 Participants
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care.
|
|---|---|---|
|
Return to Work Self-efficacy (RTW-SE)
|
6.31 Scores on a scale (1-10)
Standard Deviation 2.59
|
6.05 Scores on a scale (1-10)
Standard Deviation 2.69
|
Adverse Events
Usual Care
Usual Care Plus Vocational Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place