Clinical trial NCT03662347: Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
Official title: Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fatigue score: EMIF-SEP scale
timeFrame: changes between 0,1 and 2 years
Secondary outcomes:
measure: The quality of life: SF-36
timeFrame: changes between 0,1 and 2 years
measure: The quality of life: MuSIQoL
timeFrame: changes between 0,1 and 2 years
measure: Nutritional behaviors (physical activity and sedentary lifestyle)
timeFrame: changes between 0,1 and 2 years
measure: Psychological state (optimism, anxiety, depression)
timeFrame: changes between 0,1 and 2 years
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine
Study officials:
affiliation: CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine
name: Jonathan EPSTEIN
role: PRINCIPAL_INVESTIGATOR
References: