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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Vocational Rehabilitation

• Registration Number: NCT06805318
• Lead Sponsor: Fondazione Italiana Sclerosi Multipla

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study Start: 2025-01-15
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-03
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Interception	Up to 6 months	Number of eligible participants who has been invited to the VR intervention.
Hospital Anxiety Depression scale (HADS)	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.
Modified Fatigue (MFIS-21)	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)
Multiple Sclerosis Neuropsychological Questionnaire for patient (MSNQ-p)	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.
WHO Disability Assessment Schedule (WHODAS)	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.
Adherence	Up to 6 months	Number of participants who complete the VR intervention.
Lost to Follow-Up	Up to 6 months	Number of dropouts from the VR intervention.
Acceptance	Up to 6 months	Number of participants who accepts to be included in the VR intervention.
Canadian Occupational Performance Measure (COPM)	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.
Client Satisfaction Questionnaire (CSQ)	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)
Global Perceived Effect (GPE) scale	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.
Barthel Index (BI)	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)

Trial Locations

Locations (2)

IRCCS Fondazione Santa Lucia; 🇮🇹 Rome, Lazio, Italy

Servizio di Riabilitazione AISM Liguria, Italian Multiple Sclerosis Society; 🇮🇹 Genoa, Liguria, Italy