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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.
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:
Secondary objective:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics | Demographic and baseline variables include age, gender, race, baseline disease severity, sleep history, and baseline sleep assessments. | Initial visit (Day 0) |
| Duration of the disease |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with MS in Argentina.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Norma Aydeé Deri | Hospital Fernandez, Buenos Aires, Argentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Fernandez de Buenos Aires | Capital Federal | Buenos Aires | Argentina |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D003863 | Depression |
| 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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Identifying the number of years since disease onset.
| Initial visit (Day 0) |
| Treatment or treatment changes | identifying the agents used for the treatment and the treatment duration. | Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) |
| Expanded Disability Status Scale (EDSS) | EDSS >=3,5 disability and EDSS <=3,5 no disability | Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) |
| Hamilton Depression Inventory-17 (HDI-17) | Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) |
| Fatigue Severity Scale (FSS) | Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |