Clinical trial NCT06966115: Optimising Access to Vocational Rehabilitation for People With Multiple Sclerosis
Official title: Optimising Access to Vocational Rehabilitation Through Multiple Sclerosis Charities: A Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Vocational Rehabilitation
multiple sclerosis
job retention
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Work Productivity and Activity Impairment Questionnaire- Multiple Sclerosis
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
Secondary outcomes:
measure: Goal Attaiment Scaling
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Generalised Anxiety Disorder - 7 (GAD-7)
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Perceived Difficulties Questionnaire
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Health-related quality of life
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Fatigue levels
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Self-efficacy
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
measure: Reasonable Adjustments
timeFrame: At baseline, and -6, -9 and 12-months post-randomisation.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
References: