A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment
NCT ID: NCT00702065
Last Updated: 2014-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
599 participants
OBSERVATIONAL
2007-11-30
2010-10-31
Brief Summary
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Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.
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Detailed Description
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Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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1
No interventions assigned to this group
2
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient is 18 years old or more (inclusive, at time of informed consent).
3. Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)
4. Patient can be with or without treatment
5. Patient has read, understood, signed and dated informed consent form
6. Patient is able to fill in the questionnaire by him/herself
Exclusion Criteria
2. Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure
3. Patient suffers from dementia in the opinion of the investigator
4. Patient suffers of major medical or psychiatric illness in the opinion of the investigator
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Las Vegas, Nevada, United States
Reseach site
Buenos Aires, , Argentina
Research Site
Buenos Aires, , Argentina
Research Site
Camperdown, , Australia
Research Site
Melbourne, , Australia
Research Site
New Lambton Heights, , Australia
Research Site
Victoria, , Australia
Research Site
Graz, , Austria
Research Site
Linz, , Austria
Research Site
Vienna, , Austria
Research Site
Lomme, , France
Research Site
Marseille, , France
Research Site
Bad Wildbad, , Germany
Research Site
Bochum, , Germany
Research Site
München, , Germany
Research Site
Afula, , Israel
Research Site
Ashkelon, , Israel
Research Site
Haifa, , Israel
Research Site
Holon, , Israel
Research Site
Brindisi, , Italy
Research Site
Centro Bologna, , Italy
Research Site
Florence, , Italy
Research Site
Modena, , Italy
Research Site
Palermo, , Italy
Research Site
Lorenskog, , Norway
Reseach Site
Málaga, , Spain
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Glasgow, , United Kingdom
Research Site
Nottingham, , United Kingdom
Countries
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References
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Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life(MusiQoL) questionnaire to changes in disability in subjects with multiple sclerosis: 12-month results. Eur J Neurol 2010;17(Suppl 3):486
Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life and Short Form-36 questionnaires to Expanded Disability Status Scale score changes in subjects with multiple sclerosis: 12-month results of an international observational study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): 13-16 October 2010, Gothenburg, Sweden; P650
Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life questionnaire to Expanded Disability Status Scale score changes in subjects with Multiple Sclerosis: Month 12 results from an international observational study. 13th Annual ISPOR Annual European Congress: November 2010, Prague, Czech Republic; P25667
Baumstarck K, Pelletier J, Boucekine M, Auquier P; MusiQoL study group. Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study. Rev Neurol (Paris). 2015 Feb;171(2):173-80. doi: 10.1016/j.neurol.2014.09.005. Epub 2015 Jan 2.
Boucekine M, Loundou A, Baumstarck K, Minaya-Flores P, Pelletier J, Ghattas B, Auquier P. Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study. BMC Med Res Methodol. 2013 Feb 15;13:20. doi: 10.1186/1471-2288-13-20.
Other Identifiers
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27904
Identifier Type: -
Identifier Source: org_study_id
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