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NCT Number: NCT06805318

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Santa Lucia, Rome, Lazio, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Presence of other pathologies impacting on work productivity

Treatment and study plan

Vocational Rehabilitation intervention for pwMS

Behavioral

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.

Primary outcomes

  1. Interception

    Time frame: Up to 6 months

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

  2. Acceptance

    Time frame: Up to 6 months

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

  3. Adherence

    Time frame: Up to 6 months

    Number of participants who complete the VR intervention.

  4. Lost to Follow-Up

    Time frame: Up to 6 months

    Number of dropouts from the VR intervention.

  5. Canadian Occupational Performance Measure (COPM)

    Time frame: Baseline, up to 6 months

    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.

  6. Client Satisfaction Questionnaire (CSQ)

    Time frame: Up to 6 months

    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)

  7. Global Perceived Effect (GPE) scale

    Time frame: Up to 6 months

    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.

  8. Barthel Index (BI)

    Time frame: Baseline, up to 6 months

    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)

  9. Hospital Anxiety Depression scale (HADS)

    Time frame: Baseline, up to 6 months

    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.

  10. Modified Fatigue (MFIS-21)

    Time frame: Baseline, up to 6 months

    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)

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

    Time frame: Baseline, up to 6 months

    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.

  12. WHO Disability Assessment Schedule (WHODAS)

    Time frame: Baseline, up to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Salivetto, MS

CONTACT

[email protected]

+39 0102713832

Michela Ponzio, PhD

CONTACT

[email protected]

+39 0102713246

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Sclerosi Multipla

Other

Collaborators

  • Department of Health Science (DiSSaL), University of Genoa, Genoa
  • IRCCS San Martino Hospital, Genoa
  • IRCCS Santa Lucia Foundation, Rome
  • Italian Multiple Sclerosis Society (AISM)Liguria, Genoa
  • Italian Workers' Compensation Authority (INAIL)

Registry information

Official study title

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

Acronym: RialSM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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