A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina
Condition: Multiple Sclerosis, Relapsing-remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fatigue
Study type: Observational

Summary: 
      This is an observational, non-controlled, multicentric, prospective study planned to be
      conducted in 66 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina.
      Fatigue is recognized as one of the most frequent symptoms of MS with a high incidence in MS
      subjects. The link between fatigue and the degree of disability and other manifestations of
      the disease, such as depression has not been yet clearly understood. Hence, this study aims
      to understand the way in which fatigue impairs the quality of life (QoL) of MS subjects. This
      epidemiologic study can contribute to a better understanding of the way in which fatigue
      correlates with depression and the intensity with which both situations impact on the QoL of
      MS subjects.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects diagnosed with MS in Argentina.
      
Keywords: Multiple sclerosis; Multiple sclerosis, Relapsing-remitting; Expanded Disability Status Scale; Fatigue; Hamilton Depression Inventory; Depression