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

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).

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis

Detailed Description

Two-year patient follow-up is planned with data collection at 0, 12 and 24 months.

In addition to data already collected as part of the establishment and monitoring of the ReLSEP registry, more specific data for this study will be collected at 0, 12 and 24 months by self-questionnaires sent to patients' homes.

• Study Type: Observational
• Enrollment (Anticipated): 2100

Contacts and Locations

Study Locations

• France
  • Vandoeuvre Les Nancy, France, 54511
    • Recruiting
    • CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine
    • Contact: Jonathan EPSTEIN; Email: j.epstein@chru-nancy.fr
    • Principal Investigator: Jonathan EPSTEIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of life: SF-36	measured by SF-36 (36-Item Short Form Survey)	changes between 0,1 and 2 years
The quality of life: MuSIQoL	measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)	changes between 0,1 and 2 years
Nutritional behaviors (physical activity and sedentary lifestyle)	measured by GPAQ (Global Physical Activity Questionnaire)	changes between 0,1 and 2 years
Psychological state (optimism, anxiety, depression)	measured by HAD (Hospital Anxiety and Depression scale)	changes between 0,1 and 2 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Jonathan EPSTEIN, CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2018-A00403-52; APJC2016/SeDIF_SEP-EPSTEIN/AS (Other Identifier: sponsor code)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No