Multiple Sclerosis Clinical Trial
— ECOPASEPOfficial title:
Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden and Social Participation.
The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. To the investigators' knowledge, there is currently no data including intangible costs related to caregivers and calculating the overall economic cost of Multiple Sclerosis, particularly, in France.
Status | Completed |
Enrollment | 233 |
Est. completion date | June 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participant aged 18 or more - Confirmed MS diagnosis (McDonald 2005) - Defined type of MS according classification of Lublin and Reingold Exclusion Criteria: - Subject living in an institution - Severe cognitive dysfunction preventing to answer questionnaire - Subject already included in other clinical study (phase 1 to 3) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University | La Ligue Française Contre la Sclérose en Plaques, Novartis, Région Nord-Pas de Calais, France, Université de Lille |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annual average total health care cost of the Multiple Sclerosis by patient | Global cost of Multiple Sclerosis considering direct medical and non-medical costs as well as the indirect and intangible costs associated to the patient-caregiver | 1 year | No |
Secondary | Score of social participation | Correlation between the score of social participation and health care costs of the disease will be determined | 1 year | No |
Secondary | Validity of life quality measurement EQ-5D | The EQ-5D index is a generic measure of health status that provides a simple descriptive profile and a single index value that can be used in the clinical and economic evaluation of health care | 1 year | No |
Secondary | Utilities measured by the Short Form-6D (SF-6D) | The SF-6D is a utility index based on a descriptive system composed of 11 items from six dimensions of the SF-36: physical functioning, role limitations, social functioning, pain, mental functioning and vitality. | 1 year | No |
Secondary | QALY | Health related quality in life will be measured as Quality adjusted life years (QALY) | 1 year | No |
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