Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP) (SeDiF_SEP)
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|ClinicalTrials.gov Identifier: NCT03662347|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 8, 2020
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).
|Condition or disease|
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|
|Estimated Enrollment :||2100 participants|
|Official Title:||Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)|
|Actual Study Start Date :||March 19, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
- Fatigue score: EMIF-SEP scale [ Time Frame: 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)
- The quality of life: SF-36 [ Time Frame: changes between 0,1 and 2 years ]measured by SF-36 (36-Item Short Form Survey)
- The quality of life: MuSIQoL [ Time Frame: changes between 0,1 and 2 years ]measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)
- Nutritional behaviors (physical activity and sedentary lifestyle) [ Time Frame: changes between 0,1 and 2 years ]measured by GPAQ (Global Physical Activity Questionnaire)
- Psychological state (optimism, anxiety, depression) [ Time Frame: changes between 0,1 and 2 years ]measured by HAD (Hospital Anxiety and Depression scale)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662347
|Contact: Jonathan EPSTEINfirstname.lastname@example.org|
|Contact: Andreia CARVALHO DE FREITAS||+33383859305||A.CARVALHODEFREITAS@chru-nancy.fr|
|CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine||Recruiting|
|Vandoeuvre Les Nancy, France, 54511|
|Contact: Jonathan EPSTEIN email@example.com|
|Principal Investigator: Jonathan EPSTEIN|
|Principal Investigator:||Jonathan EPSTEIN||CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine|