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

Multiple Sclerosis Clinical Trial

— ECOPASEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592265
• Other study ID #: RC-P0018
• 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

Related Conditions & MeSH terms

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

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