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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02592265
Other study ID # RC-P0018
Secondary ID
Status Completed
Phase N/A
First received October 11, 2015
Last updated September 19, 2016
Start date October 2012
Est. completion date June 2016

Study information

Verified date October 2015
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority France: Ministry of HealthFrance: French Data Protection Authority
Study type Observational

Clinical Trial Summary

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.


Description:

The goal of this study is to evaluate prospectively the economic burden of Multiple Sclerosis (MS) in France by calculating direct costs (medical and non-medical) and indirect costs and by estimating consequences of MS on utility (QALY) of patients and caregivers in a societal perspective.


Recruitment information / eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Lille Catholic University La Ligue Française Contre la Sclérose en Plaques, Novartis, Région Nord-Pas de Calais, France, Université de Lille

Outcome

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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