Clinical trial NCT06805318: Feasibility of a Vocational Rehabilitation Intervention for Job Retention in Workers With MS-RiaLSM Intervention Project
Official title: Development and Assessment of a Vocational Rehabilitation Intervention for Job Retention in Workers With Multiple Sclerosis (RiaLSM Intervention Project)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Vocational Rehabilitation
Keywords: Multiple Sclerosis
Vocational Rehabilitation
Occupational Rehabilitation
Return to Work
Work Maintenance
Work Placement
Vocational Guidance
Reasonable Accomodation
Lead sponsor: Fondazione Italiana Sclerosi Multipla
Sponsor class: OTHER
Collaborators: name: Italian Multiple Sclerosis Society (AISM)Liguria, Genoa
name: IRCCS Santa Lucia Foundation, Rome
name: IRCCS San Martino Hospital, Genoa
name: Italian Workers' Compensation Authority (INAIL)
name: Department of Health Science (DiSSaL), University of Genoa, Genoa
First posted: 2025-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Interception
timeFrame: Up to 6 months
measure: Acceptance
timeFrame: Up to 6 months
measure: Adherence
timeFrame: Up to 6 months
measure: Lost to Follow-Up
timeFrame: Up to 6 months
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline, up to 6 months
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Up to 6 months
measure: Global Perceived Effect (GPE) scale
timeFrame: Up to 6 months
measure: Barthel Index (BI)
timeFrame: Baseline, up to 6 months
measure: Hospital Anxiety Depression scale (HADS)
timeFrame: Baseline, up to 6 months
measure: Modified Fatigue (MFIS-21)
timeFrame: Baseline, up to 6 months
measure: Multiple Sclerosis Neuropsychological Questionnaire for patient (MSNQ-p)
timeFrame: Baseline, up to 6 months
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: Baseline, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS Fondazione Santa Lucia
state: Lazio
city: Genoa
country: Italy
facility: Servizio di Riabilitazione AISM Liguria, Italian Multiple Sclerosis Society
state: Liguria
Study officials:
affiliation: Fondazione Italiana Sclerosi Multipla
name: Giampaolo Brichetto, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.