Optimising Access to Vocational Rehabilitation for People With Multiple Sclerosis

NCT06966115 | Not Yet Recruiting

• 2 other identifiers: FMHS 102-0325184
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Explore the feasibility and acceptability of providing employment support through MS charities.
2. 2.Determine the parameters for a future large-scale randomised controlled trial.
3. 3.Explore the experiences of those receiving and delivering the MSVR intervention.

Conditions

Multiple Sclerosis

Keywords

Vocational Rehabilitation; multiple sclerosis; job retention

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life

  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).

  At baseline, and -6, -9 and 12-months post-randomisation.

• Work Productivity and Activity Impairment Questionnaire- Multiple Sclerosis

  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.

  At baseline, and -6, -9 and 12-months post-randomisation.

Secondary Outcomes (8)

• Goal Attaiment Scaling

  At baseline, and -6, -9 and 12-months post-randomisation.

• Patient Health Questionnaire - 9 (PHQ-9)

  At baseline, and -6, -9 and 12-months post-randomisation.

• Generalised Anxiety Disorder - 7 (GAD-7)

  At baseline, and -6, -9 and 12-months post-randomisation.

• Perceived Difficulties Questionnaire

  At baseline, and -6, -9 and 12-months post-randomisation.

• Health-related quality of life

  At baseline, and -6, -9 and 12-months post-randomisation.

Study Arms (2)

MSVR

EXPERIMENTAL

Participants in the MSVR group will be asked to complete a questionnaire booklet to explore variables of interest. Participants will then be invited to an optional semi-structured, feedback interview to provide qualitative information on their experience of the intervention.

Behavioral: Multiple Sclerosis Vocational Rehabilitation (MSVR)

Control Group

NO INTERVENTION

Usual care

Interventions

Multiple Sclerosis Vocational Rehabilitation (MSVR) BEHAVIORAL

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 * Managing mood difficulties * Signposting to local and national resources. MSVR addresses the individual needs of the person with MS and offers advice remotely (e.g., via telephone, videoconference, or email). The sessions will be arranged at a time convenient for the person, and the support needed will vary according to the complexity of their workplace difficulties.

MSVR

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 11, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)