A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01080001|
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : March 7, 2014
|Condition or disease|
|Multiple Sclerosis, Relapsing-remitting|
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.
- To determine the impact of fatigue on QoL of MS subjects in Argentina
- 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.
|Study Type :||Observational|
|Actual Enrollment :||71 participants|
|Official Title:||Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||November 2012|
- 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) ]
- Demographic characteristics [ Time Frame: Initial visit (Day 0) ]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) ]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) ]identifying 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) ]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) ]
- 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) ]
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): NCT01080001
|Hospital Fernandez de Buenos Aires|
|Capital federal, Buenos Aires, Argentina|
|Principal Investigator:||Dr. Norma Aydeé Deri||Hospital Fernandez, Buenos Aires, Argentina|