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Not yet recruiting NCT06966115

Optimising Access to Vocational Rehabilitation for People With Multiple Sclerosis

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multiple Sclerosis Vocational Rehabilitation (MSVR).
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 66 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Optimising Access to Vocational Rehabilitation Through Multiple Sclerosis Charities: A Feasibility Randomised Controlled Trial

Overview

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.

Interventions

  • Behavioral Multiple Sclerosis Vocational Rehabilitation (MSVR)
    MSVR involves an initial assessment (including vocational goal setting), followed by up to 10 hours of individually tailored support over six months according to need. The support will focus on supporting the person with MS to remain at work by addressing topics such as: * Understanding MS * Advice on reasonable adjustments * Support requesting reasonable adjustments * Fatigue management * Managing cognition at work * Information about legal rights * Disclosure * Long-term career planning * Man

Primary outcome measures

  • Health-related quality of life [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Work Productivity and Activity Impairment Questionnaire- Multiple Sclerosis [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
Secondary outcome measures (8)
  • Goal Attaiment Scaling [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Patient Health Questionnaire - 9 (PHQ-9) [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Generalised Anxiety Disorder - 7 (GAD-7) [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Perceived Difficulties Questionnaire [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Health-related quality of life [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Fatigue levels [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Self-efficacy [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]
  • Reasonable Adjustments [Time frame: At baseline, and -6, -9 and 12-months post-randomisation.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • University of Nottingham — Nottingham

Publications

  • De Dios Perez B, Kendrick D, das Nair R, Evangelou N, Newsome I, Radford K. Optimising access to vocational rehabilitation through multiple sclerosis charities: Protocol for a feasibility randomised controlled trial. PLoS One. 2025 Jun 27;20(6):e0325570. doi: 10.1371/journal.pone.0325570. eCollection 2025. PMID 40577335

Identifiers

NCT: NCT06966115 · FMHS 102-0325 · 184

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗