Multiple Sclerosis Clinical Trial
Official title:
Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (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).
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.
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