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).
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
2,100
CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine
Vandœuvre-lès-Nancy, France
RECRUITINGFatigue 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)
Time frame: changes between 0,1 and 2 years
The quality of life: SF-36
measured by SF-36 (36-Item Short Form Survey)
Time frame: changes between 0,1 and 2 years
The quality of life: MuSIQoL
measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)
Time frame: changes between 0,1 and 2 years
Nutritional behaviors (physical activity and sedentary lifestyle)
measured by GPAQ (Global Physical Activity Questionnaire)
Time frame: changes between 0,1 and 2 years
Psychological state (optimism, anxiety, depression)
measured by HAD (Hospital Anxiety and Depression scale)
Time frame: changes between 0,1 and 2 years
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