Optimising Access to Vocational Rehabilitation for People With Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06966115
• Lead Sponsor: University of Nottingham

Brief Summary

People with multiple sclerosis (MS) often leave the workforce prematurely due to MS symptoms and difficulties managing workplace relationships and performance. Vocational rehabilitation (VR) can improve job retention outcomes for people with MS, but there is a lack of evidence on the effectiveness of these interventions.

A psychologist and occupational therapist-delivered VR intervention was previously developed to support people with MS to remain in paid employment. This programme was tested in a community setting and within the UK National Health Service (NHS). The preliminary findings demonstrate that the intervention is highly acceptable to people with MS and their employers and helped participants with MS to meet their vocational goals. However, the study also identified various barriers (e.g., lack of staff, service structure, etc.) to delivering this programme more widely within a healthcare setting.

Because of this, patient and public involvement (PPI) representatives suggested testing the VR intervention within the services provided by MS charities. This approach could be beneficial to reach people with MS who might be in the earlier stages of the illness and looking for information or who have not considered discussing "work" with their healthcare providers.

Therefore, the VR intervention MSVR ("multiple sclerosis vocational rehabilitation") was adapted to be delivered by non-specialists working for MS charities. Over recent years, the practice of training non-specialists to deliver evidence-based and complex interventions has increased to reach communities where there is a lack of resources or to help increase the reach of these interventions.

This study aims to:

1. Explore the feasibility and acceptability of providing employment support through MS charities.

2. Determine the parameters for a future large-scale randomised controlled trial.

3. Explore the experiences of those receiving and delivering the MSVR intervention.

Sixty people with MS in paid employment will be recruited to receive support with employment tailored to their needs over six months. Participants with MS will be asked to complete a booklet of questionnaires with variables known to affect employment status.

Approximately 20 participants will be asked to participate in a feedback interview at the end of the intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-06-10
• Primary Completion: 2027-07-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged ≥18
2. Can give informed consent,
3. Can communicate in English,
4. Are in paid employment (including self-employed).

Exclusion Criteria

1. Planning to retire within the next 12 months.
2. Currently receiving vocational rehabilitation support from the NHS or other employer services.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	At baseline, and -6, -9 and 12-months post-randomisation.	The short form 36 health survey questionnaire measures eight health constructs relating to physical and mental health. The scale ranges from 0-100, with 100 representing highest level of health and functioning, and lower scores representing higher levels of disability. This measure has a high internal consistency (Cronbach's alpha \>0.80) and good test-retest reliability (\>0.70).
Work Productivity and Activity Impairment Questionnaire- Multiple Sclerosis	At baseline, and -6, -9 and 12-months post-randomisation.	This questionnaire includes questions about the employment situation of the person with MS, hours missed at work due to MS, and two numerical scales measuring how MS impacts productivity at work and conducting everyday activities.; The numeric scales range from 0 (no impact) to 10 (unable to perform an activity), where a higher score represents a larger impact of MS at work and conducting everyday life activities.; The recall will be extended from seven days to four weeks.

Secondary Outcome Measures

Name	Time	Method
Goal Attaiment Scaling	At baseline, and -6, -9 and 12-months post-randomisation.	The Goal Attainment Scale (GAS) (Turner-Stokes L., 2009) will be used to ascertain the intervention's impact on the vocational goals.; Participants will be asked to evaluate whether or not they met the intervention goals using a 5-point scale from -2 (goal not met, much worse than expected) to +2 (goal met, much more than expected). A GAS T score will be calculated using the standardised formula for goal attainment. Goals are considered met if the GAS T score is \>50.
Patient Health Questionnaire - 9 (PHQ-9)	At baseline, and -6, -9 and 12-months post-randomisation.	Change in the level of depression symptoms. Higher scores indicate a worse outcome, total scores range from 0-27, scale values range from 0-3.
Generalised Anxiety Disorder - 7 (GAD-7)	At baseline, and -6, -9 and 12-months post-randomisation.	Change in the level of anxiety symptoms. Higher scores indicate a worse outcome, total scores range from 0-21, scale values range from 0-3.
Perceived Difficulties Questionnaire	At baseline, and -6, -9 and 12-months post-randomisation.	The Perceived Deficits Questionnaire (PDQ) (Sullivan et al. 1990) explores the perceived cognitive difficulties and measures four sub-scales within the questionnaire: attention/concentration, planning/organisation, retrospective memory and prospective memory.; The PDQ is a 20-item scale scored with a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The total score for the scale ranges between 0- 80 points, and the domain sub-scales range from 0-20; where a higher score represents a greater perceived cognitive deficits. There is no cut-off score for the sub-scales, but a score of ≥40 on the PDQ is considered as being in a "risk range".
Health-related quality of life	At baseline, and -6, -9 and 12-months post-randomisation.	EQ-5D-5L - Five scaled questions assess five domains of quality of life (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each response corresponds to a 1-digit number. The total responses are combined into a 5-digit number to represent the health state; e.g., 11111 represents no problems in the health state. These are then converted to an index score; higher scores indicate greater health-related quality of life.
Fatigue levels	At baseline, and -6, -9 and 12-months post-randomisation.	Modified Impact Fatigue Scale - 5 items (MFIS-5) (Fisk et al., 1994; Fischer et al., 1999). Total score ranges from 0-20; higher scores indicate greater impact of fatigue.; Scale scores range from 0-4 with 5 scaled questions.
Self-efficacy	At baseline, and -6, -9 and 12-months post-randomisation.	The Generalised Self-Efficacy Scale (GSE) assesses the participants' belief in their ability to complete tasks successfully. This scale has high internal consistency with alphas are between .76 and .90). The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Reasonable Adjustments	At baseline, and -6, -9 and 12-months post-randomisation.	Questions regarding whether the employer has provided or not reasonable adjustments to the employee in the workplace.

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Nottingham, United Kingdom