Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)

NCT03662347 | Unknown

• 2 other identifiers: 2018-A00403-52APJC2016/SeDIF_SEP-EPSTEIN/AS
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is the most common symptom and the most disabling symptom of Multiple Sclerosis, and its inefficient management can be a source of multiple consultations (increase in health costs) and a reduction in productivity (work stoppages). Hence the need to define the most effective therapeutic strategy to reduce fatigue in Multiple Sclerosis. One of the aims of this project is to provide clinical indicators that can serve as evaluation criteria for determining the most effective fatigue management strategy in Multiple Sclerosis. The primary objective of the study is to determine the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptomatic State (PASS) for fatigue in Multiple Sclerosis. The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Fatigue score: EMIF-SEP scale

  measured by EMIF-SEP scale (French version of the fatigue impact scale in multiple sclerosis): 40 items and 4 dimensions (physical, psychological, cognitive, social)

  changes between 0,1 and 2 years

Secondary Outcomes (4)

• The quality of life: SF-36

  changes between 0,1 and 2 years

• The quality of life: MuSIQoL

  changes between 0,1 and 2 years

• Nutritional behaviors (physical activity and sedentary lifestyle)

  changes between 0,1 and 2 years

• Psychological state (optimism, anxiety, depression)

  changes between 0,1 and 2 years

Eligibility Criteria

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

Study Population

The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

You may qualify if:

• Patient \> or = 18 years old
• Patient with Multiple Sclerosis according to Mc Donald's diagnostic criteria
• Patient registered in the RelSEP registry
• Being able to fill out a questionnaire
• Person who has received complete information on the organization of the research and who has not objected to the exploitation of his data

You may not qualify if:

• Patients no longer residing in Lorraine
• Bedridden patients
• Patients under guardianship, curatorship or safeguard of justice
• Patients with other serious pathologies with heavy treatments (eg cancer under chemotherapy or radiotherapy).

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan EPSTEIN

  CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan EPSTEIN

CONTACT

+33383859304; j.epstein@chru-nancy.fr

Andreia CARVALHO DE FREITAS

CONTACT

+33383859305; A.CARVALHODEFREITAS@chru-nancy.fr

Study Design

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

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: March 19, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 8, 2020

Record last verified: 2020-01

Locations

FR (1)