Multiple Sclerosis
Conditions
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.
Interventions
None listed
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score: EMIF-SEP scale | changes between 0,1 and 2 years | measured by EMIF-SEP scale (French version of the fatigue impact scale in multiple sclerosis): 40 items and 4 dimensions (physical, psychological, cognitive, social) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The quality of life: SF-36 | changes between 0,1 and 2 years | measured by SF-36 (36-Item Short Form Survey) |
| The quality of life: MuSIQoL | changes between 0,1 and 2 years | measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire) |
| Nutritional behaviors (physical activity and sedentary lifestyle) | changes between 0,1 and 2 years | measured by GPAQ (Global Physical Activity Questionnaire) |
| Psychological state (optimism, anxiety, depression) | changes between 0,1 and 2 years | measured by HAD (Hospital Anxiety and Depression scale) |
Countries
France
Contacts
Primary ContactJonathan EPSTEIN
Backup ContactAndreia CARVALHO DE FREITAS
Outcome results
None listed