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Multiple SclerosisRialSMNCT06805318

Feasibility of a Vocational Rehabilitation Intervention for Job Retention in Workers With MS-RiaLSM Intervention Project

A study testing Vocational Rehabilitation intervention for pwMS in people with Multiple Sclerosis and Vocational Rehabilitation, run by Fondazione Italiana Sclerosi Multipla at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system with both inflammatory and degenerative characteristics that affects approximately 136,000 people in Italy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis, Vocational Rehabilitation
What is being tested?
Vocational Rehabilitation intervention for pwMS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesItaly
Study dates
15 Jan 2025to 31 Oct 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed MS diagnosis
  • Age ≥18 years
  • Currently employed at the beginning of the study entry
  • Have worked at least one day in the last 12 months
  • MSQ-Job >=15
  • Written informed consent

Who cannot join

  • Presence of other pathologies impacting on work productivity

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michela Ponzio, PhD contact

+39 0102713246

michela.ponzio@aism.it

Marco Salivetto, MS contact

+39 0102713832

marco.salivetto@aism.it

Italy2 sites, 2 recruiting
  • Servizio di Riabilitazione AISM Liguria, Italian Multiple Sclerosis Society

    Genoa, Liguria, 16149

    Giampaolo Brichetto, PhD, +39 0102713532, giampaolo.brichetto@aism.it

    Recruiting
  • IRCCS Fondazione Santa Lucia

    Rome, Lazio, 00179

    Maria Grazia Grasso, PhD, +39 0651501920, mg.grasso@hsantalucia.it

    Not yet recruiting

Other trials in Italy

About this study

Official title: Development and Assessment of a Vocational Rehabilitation Intervention for Job Retention in Workers With Multiple Sclerosis (RiaLSM Intervention Project)

Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system with both inflammatory and degenerative characteristics that affects approximately 136,000 people in Italy. The highest incidence of disease onset occurs between the ages of 20 and 40, which corresponds to the most productive period of a person's life. For this reason, one of the main social consequences of MS is the reduction or abandonment of work activity, which often begins in the early stages of the disease. Vocational Rehabilitation (VR) interventions, as reported in the literature, are used to manage and reduce work-related difficulties. The goal of VR is to enable individuals who experience difficulties in performing work activities to access, find, and maintain employment. This approach is characterized by its multi-professional and multidimensional nature, involving different types of interventions carried out by various professionals in diverse settings.

The overall aim of the project is to define a Vocational Rehabilitation (VR) protocol to reduce work-related challenges and promote job retention for workers with MS within the Italian healthcare and social context. The intervention will be organised into three different areas: rehabilitation, reasonable accommodation and education. Participants will receive any of the three interventions or a combination of these. The study will involve a multidisciplinary team of doctors (e.g. neurologist, physiatrist), psychologists, occupational therapists, physiotherapists, social workers, and labour law experts who will be involved according to the subject's specific needs.

Being tested
Vocational Rehabilitation intervention for pwMS
Keywords
Multiple Sclerosis, Vocational Rehabilitation, Occupational Rehabilitation, Return to Work, Work Maintenance, Work Placement, Vocational Guidance, Reasonable Accomodation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vocational Rehabilitation intervention for pwMSBehavioural

    The VR intervention will cover three areas of intervention:

    • Rehabilitation Area: this intervention has the goal of managing the work performance from a rehabilitative point of view.
    • Reasonable accommodation area: this intervention has the goal of assessing the needs of reasonable accommodations, such has workspace modification, change in organization of the activities, management of work time, etc.., and propose it to the employer.
    • Educational and Formative Area: this area is responsible for the implementation of educational intervention for the employees and the employers about multiple sclerosis and its impact on work performance, the rights and obligations of the employer and employee about disability management on the workplace.
Study groups in NCT06805318
Study groupRoleWhat they receive
VR interventionExperimentalThis is a single-arm study. Therefore, the intervention will be conducted on the whole sample. The nature of the rehabilitation program will vary and will cover three different areas: the rehabilitation area, the reasonable accommodation area, and the educational and formative area. Participants can receive any of the three types of intervention, or a combination of these, based on individual needs.
Receives: Behavioral: Vocational Rehabilitation intervention for pwMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interception

    Number of eligible participants who has been invited to the VR intervention.

    Measured: Up to 6 months

  2. Acceptance

    Number of participants who accepts to be included in the VR intervention.

    Measured: Up to 6 months

  3. Adherence

    Number of participants who complete the VR intervention.

    Measured: Up to 6 months

  4. Lost to Follow-Up

    Number of dropouts from the VR intervention.

    Measured: Up to 6 months

  5. Canadian Occupational Performance Measure (COPM)

    The COPM employs a semi-structured interview that guides patients to define their concerns in three main areas: Self-care, Productivity - Paid or unpaid work, and Leisure. For the purposes of the study, only the "Paid or unpaid work" dimension will be assessed. Participants report two different scores regarding work activities' satisfaction and performance ranging from 1 to 10.

    Measured: Baseline, up to 6 months

  6. Client Satisfaction Questionnaire (CSQ)

    The Client Satisfaction Questionnaire collects data regarding satisfaction of participants on the VR intervention, using a 4 degree Likert scale ranging from one (not satisfied at all) to 4 (completly satisfied)

    Measured: Up to 6 months

  7. Global Perceived Effect (GPE) scale

    This is a patient reported rating scale commonly used in clinical and research settings. For the purposes of the study, it is used to assess the overall perception of effectiveness related to the global VR Intervention in terms of reduction of work difficulties. A scale likert ranging from 1 to 7, where 1 indicates the lowest perceived effectiveness of the intervention on work difficulties, and 7 the highest perceived effectiveness.

    Measured: Up to 6 months

  8. Barthel Index (BI)

    The scale measures the level of autonomy in the basic activity of daily living. It assesses ten different basic activities of daily living: using the toilet, bathing, bowel functions, dressing, eating, walking, climbing stairs and moving from bed to chair. By assessing each of these functions it is possible to calculate an autonomy index ranging from 0 (totally dependent) to 100 (totally independent)

    Measured: Baseline, up to 6 months

  9. Hospital Anxiety Depression scale (HADS)

    The scale assesses the presence of mood disorders. It is one of the most self-reported questionnaires widely used in the hospital and research context. Its aim is to screen for the presence of anxiety and depression. It consists of 14 items used to define two separate scores for anxiety and depression. For both scores there is a cut-off (8) useful for classifying the clinical condition of the patient as healthy or pathological.

    Measured: Baseline, up to 6 months

  10. Modified Fatigue (MFIS-21)

    The scale measures fatigue level. It consists of 21 items, which can be summed up to define 3 dimensions of fatigue: physical, cognitive and social. Subjects can respond to the items with a likert scale ranging from 0 (no fatigue) to 4 (highest level of fatigue)

    Measured: Baseline, up to 6 months

  11. Multiple Sclerosis Neuropsychological Questionnaire for patient (MSNQ-p)

    The questionnaire identifies possible participants at risk for cognitive impairment. This is a 15 self-reported outcome aimed to assess the presence of cognitive impairment in pwMS. Items covered different domain of cognitive functioning: processing speed, dual-task processing, attention, memory, executive function, and psychosocial comportment. The response scale ranges from 0 to 4, where 0 is "problem not encountered" and 4 "occurs very Frequently". A total maximum score of 60 is computed.

    Measured: Baseline, up to 6 months

  12. WHO Disability Assessment Schedule (WHODAS)

    The scale measures the impact of health conditions in daily life activities according to the Functioning, Disability and Health (ICF) framework. This questionnaire developed by the World Health Organization aimed to assess the impact of health status on client's level of functioning in six functional domains: cognition, mobility, self-care, getting along, life activities, participation. A score on a liker scale ranging from 1 to 5 indicates the impact of disability, with 1 indicating absence of impact and 5 the greatest possible impact. Each domain consists of five items. The score of each item are summed up to obtain a score for the individual functional domain. A total score is gained summing the total score of each functional domain.

    Measured: Baseline, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start15 Jan 2025
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
The study design will be an explorative interventional pilot study. Participants will be recruited in the study among workers with MS in contact with AISM (Italian Multiple Sclerosis Society) Rehabilitation Service in Liguria, and Santa Lucia Foundation IRCCS, Rome. A sample of 30 workers with job difficulties (MSQ-Job\>=15) will be recruited for interventional study among subjects participating in a previous cross-sectional study. The VR intervention will be based on individual needs, covering three areas of intervention: the medical-rehabilitation area, the reasonable accommodation area, and the education area. During baseline evaluation, a maximum of 5 priority work difficulties will be identified for each subject. At the end of the VR intervention, the following aspects will be evaluated: resolution of work difficulties, satisfaction and effectiveness of the intervention through the Global Perceived Effect.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06805318
Sponsor's protocol ID
CET Liguria:329/2024-DBid13998
Other IDs
Grant BRic 2022, ID 31
Acronym
RialSM
Status last verified
Jan 2025
First submitted
3 Jan 2025
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vitturi BK, Rahmani A, Dini G, Montecucco A, Debarbieri N, Bandiera P, Ponzio M, Battaglia MA, Brichetto G, Inglese M, Persechino B, Durando P. Work Barriers and Job Adjustments of People with Multiple Sclerosis: A Systematic Review. J Occup Rehabil. 2023 Sep;33(3):450-462. doi: 10.1007/s10926-022-10084-1. Epub 2022 Nov 18.

    PubMed 36399281
  • Ponzio M, Pignattelli E, Verri A, Grange E, Persechino B, Vitturi BK, Bandiera P, Manacorda T, Inglese M, Durando P, Battaglia MA. Job Retention by People With Disabilities: A Qualitative Study of the Perspectives of People With Multiple Sclerosis. Med Lav. 2024 Jun 21;115(3):e2024018. doi: 10.23749/mdl.v115i3.15947.

    PubMed 38922837
  • Ponzio M, Podda J, Pignattelli E, Verri A, Persechino B, Vitturi BK, Bandiera P, Manacorda T, Inglese M, Durando P, Battaglia MA. Work Difficulties in People with Multiple Sclerosis. J Occup Rehabil. 2024 Sep;34(3):606-617. doi: 10.1007/s10926-023-10149-9. Epub 2023 Nov 3.

    PubMed 37921967
  • Sweetland J, Riazi A, Cano SJ, Playford ED. Vocational rehabilitation services for people with multiple sclerosis: what patients want from clinicians and employers. Mult Scler. 2007 Nov;13(9):1183-9. doi: 10.1177/1352458507078414. Epub 2007 Jul 10.

    PubMed 17623726
  • Escorpizo R, Reneman MF, Ekholm J, Fritz J, Krupa T, Marnetoft SU, Maroun CE, Guzman JR, Suzuki Y, Stucki G, Chan CC. A conceptual definition of vocational rehabilitation based on the ICF: building a shared global model. J Occup Rehabil. 2011 Jun;21(2):126-33. doi: 10.1007/s10926-011-9292-6.

    PubMed 21328061

Questions about this trial

What is this clinical trial studying?

A study testing Vocational Rehabilitation intervention for pwMS in people with Multiple Sclerosis and Vocational Rehabilitation, run by Fondazione Italiana Sclerosi Multipla at 2 sites in Italy.

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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

Contact Michela Ponzio, PhD (+39 0102713246, michela.ponzio@aism.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interception (time frame: Up to 6 months). The study lists 12 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 NCT06805318, which also lists 5 linked publications.

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 17 Jun 2025.

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