How to Develop the Highest Possible Leading-edge Interdisciplinary Care Model for People With MS, That Will be Relevant to All Stakeholders and Declinable to Different Local Contexts With the Ultimate Goal of Ensuring the Highest Level of Quality of Care in MS.

NCT07289724 | Recruiting

• 1 other identifier: APHP250160
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and degenerative disease of the central nervous system. It is currently not curable, although several disease-modifying treatments (DMT) reduce the occurrence of relapses and slow disability progression. It affects about 2.8 million persons worldwide (1 million in Europe) with 3 women per 1 man. MS usually starts between 20 and 40 years old, and most people live with the disease for several decades, as life expectancy is reduced by 6-13 years compared to general population. Disease courses are highly heterogeneous and unpredictable at individual level. MS may lead to limited walking abilities but also to invisible symptoms: cognitive dysfunction, pain, bladder dysfunction, and fatigue. This results in a very high burden on affected persons, their families and society. Overall costs among 30 European countries were evaluated in 2010 to 14.559 million euros. The chronic nature of MS implies a high level of use of health services during the entire life span. MS-specific therapeutic options have undergone extensive development since the 2000s, as well as the understanding of the usefulness of comprehensive MS care. The usual core component of MS care is the neurologist/general practitioner (GP) dyad, and only neurologists are allowed to prescribe MS-specific DMT. With the expanding therapeutic area (and the required strategies to prevent and minimize the risks of adverse events) combined with the heterogeneity of the course and the symptoms, it is more and more difficult for a single physician to acquire and maintain the expertise necessary to comply with gold standard care. Patients may also need referrals to other specialists (physiotherapists, neuropsychologists, psychiatrists, occupational therapists…) depending on their needs. They sometimes use the terms "labyrinth" or "obstacle course" to describe the complex, non-linear, multi-professionals' pathway they are facing. In the past years, the concept of multidisciplinary MSCU emerged as an organisational innovation, and structures were established at different scales in several countries. These teams available in a single place provide the high level of expertise needed for complex cases or specific steps of the care process. They also dispense formalized diagnostic procedures, protocols for initiation and follow-up of DMT. Their organisation can vary across regions and healthcare systems and needs to be balanced with clinical practice according to local conditions. Thus, there are about 2450 neurologists (67% in public hospitals, 33% private practice) in France, and 23 MS expert centres were labeled by the Ministry of Health in 2017 (one per region, systematically in university public hospitals). In Italy, there are approximately 8000 neurologists and 240 MS centres of varying size, often located within neurology departments in public hospitals. The ability to coordinate interdisciplinary care in each MS centre depends on the capacity and quality of the local health and social care system. The presence of such a new actor in MS management leads to new questions regarding its role and place in the pre-existing system, and how the previous actors (mainly general neurologists, GP, people with MS) accept or use it. To date, little is known on the impact of MSCU on integrated care and personalized approach. Therefore, it is crucial to understand how key stakeholders, such as health professionals, payers and people affected by MS perceive this new and innovative element of the care pathway.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; care pathway; coordination of care; multiple sclerosis care units

Outcome Measures

Primary Outcomes (1)

• most appropriate care pathway

  In order to assess the care pathway as a whole, this survey will identify the key stages and characteristics that are likely to lead to a positive or negative experience of the care pathway. In order to define the most appropriate care pathway, proposals will be made, for example, on the most complex or risky moments in the pathway, the moments that require the greatest expertise in MS care.

  Baseline

Study Arms (3)

Patient

Patient with MS

Other: Focus group; Other: individual interview

Healthcare professional

Healthcare professional working with MS patients;

Other: Focus group; Other: individual interview

Carer

Carer for someone with MS

Other: Focus group; Other: individual interview

Interventions

Focus group OTHER

With regard to focus groups, these group interviews will take place at specialist centres. Three CRC centres have agreed to host them on their premises. Groups of 6 to 8 people will be invited, the average duration of half a day, or approximately 3½ hours, including welcome and a break. In each of the three approved expert centres, there will be a group composed solely of patients and carers, followed by a group composed of healthcare professionals who are experts in MS, and finally a mixed group (i.e. three FG sessions and therefore three different half-days in each centre three centres).

Carer; Healthcare professional; Patient

individual interview OTHER

The semi-structured individual interview contains topics that have been thought out in advance, but their form and order are left to the flow of the interview. This type of interview takes the form of a conversation in order to reduce the artificial nature of the exchange. It is an interaction between the researcher and the interviewee whose experience is of direct interest to the research being conducted.

Carer; Healthcare professional; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

erson diagnosed with MS, carer for someone with MS, Healthcare professional working with MS patients.

You may qualify if:

• Person diagnosed with MS;
• Carer for someone with MS;
• Healthcare professional working with MS patients;
• Adult;
• Person who has not objected to participating in the research.

You may not qualify if:

• Any person who has objected to the use of their data.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Paris

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Emmanuelle LERAY, PhD

CONTACT

+33 (0) 2 99 02 25 13; emmanuelle.leray@ehesp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 17, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)