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

NCT ID: NCT02592265

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Lille

OTHER

Sponsor Role collaborator

Région Nord-Pas de Calais, France

OTHER

Sponsor Role collaborator

La Ligue Française Contre la Sclérose en Plaques

OTHER

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud KWIATKOWSKI

Role: PRINCIPAL_INVESTIGATOR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Amélie LANSIAUX

Role: STUDY_DIRECTOR

Groupement des Hôpitaux de l'Institut Catholique de LilleGroupement des Hôpitaux de l'Institut Catholique de Lille

Other Identifiers

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RC-P0018

Identifier Type: -

Identifier Source: org_study_id

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