Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden

Completed

• Conditions: Multiple Sclerosis; Quality of Life; Physical Disability; Economic Burden; Capability; Social Interaction

• Registration Number: NCT02592265
• Lead Sponsor: Lille Catholic University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2015-08
• Status Verified: 2015-10
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Completion: 2016-06
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual average total health care cost of the Multiple Sclerosis by patient	1 year	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

Secondary Outcome Measures

Name	Time	Method
Score of social participation	1 year	Correlation between the score of social participation and health care costs of the disease will be determined
Validity of life quality measurement EQ-5D	1 year	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
Utilities measured by the Short Form-6D (SF-6D)	1 year	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.
QALY	1 year	Health related quality in life will be measured as Quality adjusted life years (QALY)