Multiple SclerosisMS_Work_HubNCT06966115
Optimising Access to Vocational Rehabilitation for People With Multiple Sclerosis
A study testing Multiple Sclerosis Vocational Rehabilitation (MSVR) in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multiple Sclerosis Vocational Rehabilitation (MSVR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18
- Can give informed consent,
- Can communicate in English,
- Are in paid employment (including self-employed).
Who cannot join
- Planning to retire within the next 12 months.
- Currently receiving vocational rehabilitation support from the NHS or other employer services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimising Access to Vocational Rehabilitation Through Multiple Sclerosis Charities: A Feasibility Randomised Controlled Trial
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.
Read more
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:
- Explore the feasibility and acceptability of providing employment support through MS charities.
- Determine the parameters for a future large-scale randomised controlled trial.
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Multiple Sclerosis Vocational Rehabilitation (MSVR)
- Keywords
- Vocational Rehabilitation, multiple sclerosis, job retention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis Vocational Rehabilitation (MSVR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multiple Sclerosis Vocational Rehabilitation (MSVR) |
| Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Secondary outcomes (8)
Goal Attaiment Scaling
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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Patient Health Questionnaire - 9 (PHQ-9)
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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Generalised Anxiety Disorder - 7 (GAD-7)
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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Perceived Difficulties Questionnaire
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".
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Health-related quality of life
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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Fatigue levels
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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Self-efficacy
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.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Reasonable Adjustments
Questions regarding whether the employer has provided or not reasonable adjustments to the employee in the workplace.
Measured: At baseline, and -6, -9 and 12-months post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start10 Jun 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca de Dios Perez, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966115
- Sponsor's protocol ID
- FMHS 102-0325
- Other IDs
- 184
- Acronym
- MS_Work_Hub
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40577335
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Access to Vocational Rehabilitation Through Multiple Sclerosis Charities: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06966115
- Acronym / sponsor ID
- MS_Work_Hub / FMHS 102-0325
- Conditions
- Multiple Sclerosis
- Keywords
- Vocational Rehabilitation, multiple sclerosis, job retention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Explore the feasibility and acceptability of providing employment support through MS charities.
- Determine the parameters for a future large-scale randomised controlled trial.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSVR | Experimental | Behavioral: Multiple Sclerosis Vocational Rehabilitation (MSVR)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. |
| Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18
- Can give informed consent,
- Can communicate in English,
- Are in paid employment (including self-employed).
Key exclusion criteria (2 listed)
- Planning to retire within the next 12 months.
- Currently receiving vocational rehabilitation support from the NHS or other employer services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 * 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. | Behavioural | MSVR |
Primary outcome
Health-related quality of life
Time frame: 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
Time frame: 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.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 40577335De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Sclerosis Vocational Rehabilitation (MSVR) in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: At baseline, and -6, -9 and 12-months post-randomisation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.