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

NCT ID: NCT06805318

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis Vocational Rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VR intervention

This 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.

Group Type EXPERIMENTAL

Vocational Rehabilitation intervention for pwMS

Intervention Type 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.

Interventions

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Vocational Rehabilitation intervention for pwMS

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Multiple Sclerosis Society (AISM)Liguria, Genoa

UNKNOWN

Sponsor Role collaborator

IRCCS Santa Lucia Foundation, Rome

UNKNOWN

Sponsor Role collaborator

IRCCS San Martino Hospital, Genoa

UNKNOWN

Sponsor Role collaborator

Italian Workers' Compensation Authority (INAIL)

UNKNOWN

Sponsor Role collaborator

Department of Health Science (DiSSaL), University of Genoa, Genoa

UNKNOWN

Sponsor Role collaborator

Fondazione Italiana Sclerosi Multipla

OTHER

Sponsor Role lead

Responsible Party

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Michela Ponzio, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giampaolo Brichetto, PhD

Role: STUDY_DIRECTOR

Fondazione Italiana Sclerosi Multipla

Locations

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IRCCS Fondazione Santa Lucia

Rome, Lazio, Italy

Site Status NOT_YET_RECRUITING

Servizio di Riabilitazione AISM Liguria, Italian Multiple Sclerosis Society

Genoa, Liguria, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Michela Ponzio, PhD

Role: CONTACT

+39 0102713246

Marco Salivetto, MS

Role: CONTACT

+39 0102713832

Facility Contacts

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Maria Grazia Grasso, PhD

Role: primary

+39 0651501920

Giampaolo Brichetto, PhD

Role: primary

+39 0102713532

References

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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.

Reference Type BACKGROUND
PMID: 36399281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38922837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37921967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17623726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21328061 (View on PubMed)

Other Identifiers

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Grant BRic 2022, ID 31

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CET Liguria:329/2024-DBid13998

Identifier Type: -

Identifier Source: org_study_id

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