A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina

• Multiple Sclerosis International Quality of Life (MusiQoL) in multiple sclerosis fatigue (MSF) [Fatigue Severity Scale (FSS) >5] versus multiple sclerosis nonfatigue (MSNF) (FSS <4) subjects [ Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) ] [ Designated as safety issue: No ]
  

• Demographic characteristics [ Time Frame: Initial visit (Day 0) ] [ Designated as safety issue: No ]
  Demographic and baseline variables include age, gender, race, baseline disease severity, sleep history, and baseline sleep assessments.
  
  
• Duration of the disease [ Time Frame: Initial visit (Day 0) ] [ Designated as safety issue: No ]
  Identifying the number of years since disease onset.
  
  
• Treatment or treatment changes [ Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) ] [ Designated as safety issue: No ]
  Idnetifying the agents used for the treatment and the treatment duration.
  
  
• Expanded Disability Status Scale (EDSS) [ Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) ] [ Designated as safety issue: No ]
  EDSS >=3,5 disability and EDSS <=3,5 no disability
  
  
• Hamilton Depression Inventory-17 (HDI-17) [ Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) ] [ Designated as safety issue: No ]
  
• Fatigue Severity Scale (FSS) [ Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) ] [ Designated as safety issue: No ]
  

Fatigue is recognized as one of the most frequent symptoms of MS and its impact on QoL of subjects is high. Fatigue in MS is sometimes considered as a prodromic symptom or as a peculiar symptom that must be differentiated from natural fatigue, pathological fatigue of other chronic diseases; as well as from fatigue caused by the excessive effort in case of gait disorder, spasticity or paresis. The origin of the fatigue symptom in MS is unknown and the cause is likely to be multifactorial. The evaluation of the fatigue is challenging, due to its variability and hence, scales such as Krupp's Fatigue Severity Scale (FSS) has been developed for measuring MS fatigue.

OBJECTIVES

Primary objective:

• To determine the impact of fatigue on QoL of MS subjects in Argentina

Secondary objective:

• To evaluate correlation between FSS and disability, depression, demographic variables; and between FSS and the use of disease modifying drugs
• To determine the impact of depression and neurological disability on QoL of MS subjects in Argentina

The subjects will be managed with the clinical and therapeutic elements that the treating doctor considers appropriate, without modifying their decisions due to the subject inclusion into the study. The epidemiologic data required by this study will be collected by the investigator from the documents in which each subject visit is registered, whether programmed or not. Once the recruiting period of 12 months is over, the collection of data will continue during the full 24 months period for each subject. The closure of the study will be marked by the follow-up of the last subject who entered the study.