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| ID | Type | Description | Link |
|---|---|---|---|
| APJC2016/SeDIF_SEP-EPSTEIN/AS | Other Identifier | sponsor code |
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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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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan EPSTEIN | Contact | +33383859304 | j.epstein@chru-nancy.fr | |
| Andreia CARVALHO DE FREITAS | Contact | +33383859305 | A.CARVALHODEFREITAS@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan EPSTEIN | CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |