Development and Assessment of a Vocational Rehabilitation Intervention for Job Retention in Workers With Multiple Sclerosis (RiaLSM Intervention Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Interception
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of other pathologies impacting on work productivity
研究组 & 干预措施
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.
干预措施: Vocational Rehabilitation intervention for pwMS (Behavioral)
结局指标
主要结局
Interception
时间窗: Up to 6 months
Number of eligible participants who has been invited to the VR intervention.
Acceptance
时间窗: Up to 6 months
Number of participants who accepts to be included in the VR intervention.
Adherence
时间窗: Up to 6 months
Number of participants who complete the VR intervention.
Lost to Follow-Up
时间窗: Up to 6 months
Number of dropouts from the VR intervention.
Canadian Occupational Performance Measure (COPM)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
Hospital Anxiety Depression scale (HADS)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Michela Ponzio, PhD
Principal Investigator
Fondazione Italiana Sclerosi Multipla