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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 233

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

At least 230 patients in secondary and tertiary centers (8) affiliated to the regional supportive care network (GSEP) in north of France.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of social participation	Correlation between the score of social participation and health care costs of the disease will be determined	1 year
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
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
QALY	Health related quality in life will be measured as Quality adjusted life years (QALY)	1 year

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Novartis; Région Nord-Pas de Calais, France; Université de Lille; La Ligue Française Contre la Sclérose en Plaques
• Investigators: Principal Investigator: Arnaud KWIATKOWSKI, Groupement des Hôpitaux de l'institut Catholique de Lille; Study Director: Amélie LANSIAUX, Groupement des Hôpitaux de l'Institut Catholique de LilleGroupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Stress, Psychological; Multiple Sclerosis; Sclerosis; Financial Stress
• Other Study ID Numbers: RC-P0018